Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049, 26465-26475 [2018-12222]
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Health care providers (Primary Care
Physician, Emergency Physician,
Nurse Practitioner and Physician
Assistant).
TBI Provider Survey .........................
600
1
15/60
150
Focus group screener ......................
Focus group questionnaire ..............
Focus group discussion guide .........
36
31
31
1
1
1
5/60
5/60
85/60
3
3
44
...........................................................
........................
........................
........................
200
Total ...........................................
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–12251 Filed 6–6–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
049
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing a publication containing
modifications the Agency is making to
the list of standards FDA recognizes for
use in premarket reviews (FDA
Recognized Consensus Standards). This
publication, entitled ‘‘Modifications to
the List of Recognized Standards,
Recognition List Number: 049’’
(Recognition List Number: 049), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: These modifications to the list of
recognized standards are applicable
June 7, 2018.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2004–N–0451 for ‘‘Food and Drug
Administration Modernization Act of
1997: Modifications to the List of
Recognized Standards, Recognition List
Number: 049.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
PO 00000
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https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
049.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
An electronic copy of Recognition List
Number: 049 is available on the internet
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
See section IV for electronic access to
the searchable database for the current
list of FDA recognized consensus
standards, including Recognition List
Number: 049 modifications and other
standards related information. Submit
written requests for a single hard copy
of the document entitled ‘‘Modifications
to the List of Recognized Standards,
Recognition List Number: 049’’ to Scott
Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring,
MD 20993. Send one self-addressed
adhesive label to assist that office in
processing your request, or fax your
request to 301–847–8144.
FOR FURTHER INFORMATION CONTACT:
Scott Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring,
MD 20993, 301–796–6287,
CDRHStandardsStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115)
amended section 514 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360d). Amended section
514 allows FDA to recognize consensus
standards developed by international
and national organizations for use in
satisfying portions of device premarket
review submissions or other
requirements.
In the Federal Register notice of
February 25, 1998 (63 FR 9561), FDA
announced the availability of a guidance
entitled ‘‘Recognition and Use of
Consensus Standards.’’ The notice
described how FDA would implement
its standard recognition program and
provided the initial list of recognized
standards. The guidance was updated in
September 2007 and is available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm077274.htm.
Modifications to the initial list of
recognized standards, as published in
the Federal Register, can be accessed at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
These notices describe the addition,
withdrawal, and revision of certain
standards recognized by FDA. The
Agency maintains hypertext markup
language (HTML) and portable
document format (PDF) versions of the
list of FDA Recognized Consensus
Standards. Additional information on
the Agency’s standards program is
available at https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/Standards/default.htm.
II. Modifications to the List of
Recognized Standards, Recognition List
Number: 049
FDA is announcing the addition,
withdrawal, correction, and revision of
certain consensus standards the Agency
is recognizing for use in premarket
submissions and other requirements for
devices. FDA is incorporating these
modifications to the list of FDA
Recognized Consensus Standards in the
Agency’s searchable database. FDA is
using the term ‘‘Recognition List
Number: 049’’ to identify the current
modifications.
In table 1, FDA describes the
following modifications: (1) The
withdrawal of standards and their
replacement by others, if applicable; (2)
the correction of errors made by FDA in
listing previously recognized standards;
and (3) the changes to the
supplementary information sheets of
recognized standards that describe
revisions to the applicability of the
standards.
In section III, FDA lists modifications
the Agency is making that involve the
initial addition of standards not
previously recognized by FDA.
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Old recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
A. Anesthesiology
........................
1–95 ..................
........................
1–107 ................
........................
1–109 ................
1–121 ................
........................
1–129
1–128 ................
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1–86 ..................
1–130
ISO 8185 Third edition 2008–06–15 (Corrected version), Respiratory
tract humidifiers for medical use—Particular requirements for respiratory humidification systems.
ISO 5366–3 Second edition 2001–08–15 Anaesthetic and Respiratory
Equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy
Tubes [Including TECHNICAL CORRIGENDUM 1 (2003)].
ANSI/AAMI/ISO 5356–1:2004 Anaesthetic and respiratory equipment—Conical connectors—Part 1: Cones and sockets.
ANSI/AAMI/ISO 5362:2006 Anaesthetic reservoir bags .........................
ISO 5359 Fourth edition 2014–10–01 Anaesthetic and respiratory
equipment—Low-pressure hose assemblies for use with medical
gases [Including AMENDMENT 1 (2017)].
ISO 18082 First edition 2014–06–15 Anaesthetic and respiratory
equipment—Dimensions of noninterchangeable screw-threaded
(NIST) low-pressure connectors for medical gases [Including
AMENDMENT 1 (2017)].
Withdrawn. See 1–138.
Withdrawn. See 1–117.
Transferred. See 1–62.
Transferred. See 1–75.
Withdrawn and replaced with
newer version including amendment.
Withdrawn and replaced with
newer version including amendment.
B. Biocompatibility
2–118 ................
........................
2–120 ................
........................
2–153 ................
........................
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ANSI/AAMI/ISO 10993–11:2006/(R)2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity.
ANSI/AAMI/ISO 10993–6:2007/(R)2014 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation.
ANSI/AAMI/ISO 10993–5:2009/(R)2014 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity.
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Transferred. See 2–176.
Withdrawn.
Transferred. See 2–245.
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
2–156 ................
........................
2–163 ................
........................
2–165 ................
........................
2–171 ................
2–249
2–172 ................
........................
2–173 ................
........................
2–180 ................
........................
2–181 ................
........................
2–190 ................
........................
2–198 ................
........................
2–207 ................
2–250
2–221 ................
........................
2–226 ................
........................
2–229 ................
2–251
2–230 ................
2–252
2–231 ................
2–253
ANSI/AAMI/ISO 10993–1:2009/(R)2013 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process.
ANSI/AAMI/ISO 10993–9:2009/(R)2014 Biological evaluation of medical devices—Part 9: Framework for identification and quantification
of potential degradation products.
ANSI/AAMI/ISO 10993–14:2001/(R) 2011 Biological evaluation of
medical devices—Part 14: Identification and quantification of degradation products form ceramics.
ISO 10993–16 Third edition 2017–05 Biological evaluation of medical
devices—Part 16: Toxicokinetic study design for degradation products and leachables.
ANSI/AAMI/TIR 10993–19:2006 Biological evaluation of medical devices—Part 19: Physicochemical, morphological, and topographical
characterization of materials.
ANSI/AAMI/ISO 10993–10:2010/(R)2014 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization.
ANSI/AAMI/ISO 10993–16:2010/(R)2014 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation
products and leachables from medical devices.
ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices
for human subjects—Good clinical practice [Including: Technical
Corrigendum 1 (2011)].
ANSI/AAMI/ISO 10993–13:2010/(R)2014 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation
products from polymeric medical devices.
ANSI/AAMI/ISO 10993–12:2012 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials.
ASTM F756–17 Standard Practice for Assessment of Hemolytic Properties of Materials.
ANSI/AAMI/ISO 10993–2:2006 (R2014) Biological evaluation of medical devices—Part 2: Animal welfare requirements.
ANSI/AAMI/ISO 10993–3:2014 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
USP 40–NF35:2017 <87> Biological Reactivity Test, In Vitro—Direct
Contact Test.
USP 40–NF35:2017 <87> Biological Reactivity Test, In Vitro—Elution
Test.
USP 40–NF35:2017 <88> Biological Reactivity Tests, In Vivo ..............
2–232 ................
2–254
USP 40–NF35:2017 <151> Pyrogen Test (USP Rabbit Test) ...............
2–234 ................
........................
2–236 ................
........................
2–239 ................
........................
2–242 ................
........................
ANSI/AAMI/ISO 10993–4:2002/(R) 2013 & A1:2006/(R)2013 Biological
evaluation of medical devices—Part 4: Selection of tests for interaction with blood [Including AMENDMENT 1 (2006)].
ANSI/AAMI/ISO 10993–17:2002(R) 2012 Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable
substances.
ANSI/AAMI/ISO TIR 10993–20:2006 Biological Evaluation of Medical
Devices—Part 20: Principles and methods for immunotoxicology
testing of medical devices.
ANSI/AAMI/ISO TIR 37137:2014 Cardiovascular biological evaluation
of medical devices—Guidance for absorbable implants.
Title of standard 1
Change
Transferred. See 2–220.
Transferred. See 2–168.
Transferred. See 2–170.
Withdrawn and
newer version.
replaced
Transferred. See 2–167.
Transferred. See 2–174.
Withdrawn.
Transferred. See 2–205.
Transferred. See 2–169.
Transferred. See 2–191.
Withdrawn and replaced
newer version.
Transferred. See 2–222.
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........................
3–83 ..................
........................
3–101 ................
........................
3–106 ................
........................
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ANSI/AAMI/ISO
81060–1:2007/(R)2013
Non-invasive
sphygmomanometers—Part 1: Requirements and test methods for nonautomated measurement type.
ANSI/AAMI/ISO
14708–5:2010
Implants
for
surgery—Active
implantable medical devices—Part 5: Circulatory support devices.
ANSI/AAMI/IEC 60601–2–27:2011 Medical electrical equipment—Part
2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
ANSI/AAMI/IEC 60601–2–25:2011/(R)2016 Medical electrical equipment—Part 2–25: Particular requirements for the basic safety and
essential performance of electrocardiographs.
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with
Transferred. See 2–228.
Withdrawn and replaced with
newer version.
Withdrawn and replaced with
newer version.
Withdrawn and replaced with
newer version.
Withdrawn and replaced with
newer version. Extent of Recognition.
Withdrawn.
Transferred. See 2–237.
Transferred. See 2–240.
Transferred. See 2–241.
C. Cardiovascular
3–80 ..................
with
Transferred. See 3–96.
Transferred. See 3–92.
Transferred. See 3–126.
Transferred. See 3–105.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
3–109 ................
........................
3–111 ................
........................
3–112 ................
........................
3–117 ................
........................
3–120 ................
........................
3–124 ................
3–150
3–128 ................
........................
3–130 ................
3–151
3–131 ................
........................
3–140 ................
........................
3–141 ................
........................
3–146 ................
........................
3–148 ................
........................
Title of standard 1
Change
ANSI/AAMI/ISO 27186:2010 Active implantable medical devices—
Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements.
ANSI/AAMI/ISO
25539–3:2011
Cardiovascular
implants—
Endovascular devices—Part 3: Vena cava filters.
ANSI/AAMI/ISO 7199:2009 Cardiovascular implants and artificial organs—Blood gas exchangers (oxygenators).
ANSI/AAMI/ISO 81060–2 Second edition 2013–05–01 Non-invasive
sphygmomanometers—Part 2: Clinical validation of automated
measurement type.
ANSI/AAMI/ISO
25539–2:2012
Cardiovascular
implants—
Endovascular devices—Part 2: Vascular stents.
ISO 7199 Third edition 2016–11–15 Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators).
ANSI/AAMI/ISO 14117:2012 Active implantable medical devices—
Electromagnetic compatibility—EMC test protocols for implantable
cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.
ANSI/AAMI/IEC 80601–2–30:2009 & A1:2013/(R2016) Medical electrical equipment—Part 2–30: Particular requirements for the basic
safety and essential performance of automated non-invasive sphygmomanometers.
ANSI/AAMI/ISO 27185:2012 Cardiac rhythm management devices—
Symbols to be used with cardiac rhythm management device labels,
and information to be supplied—General requirements.
ANSI/AAMI/ISO 5840–3:2013 Cardiovascular implants—Cardiac valve
prostheses—Part 3: Heart valve substitutes implanted by
transcatheter techniques.
ANSI/AAMI/ISO 5841–3:2013 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS–1) for implantable pacemakers.
ANSI/AAMI/ISO 5840–1:2015 Cardiovascular implants—Cardiac valve
prostheses—Part 1: General requirements.
ANSI/AAMI/ISO 5840–2:2015 Cardiovascular implants—Cardiac valve
prostheses—Part 2: Surgically implanted heart valve substitutes.
Transferred. See 3–89.
Transferred. See 3–103.
Transferred. See 3–124.
Transferred. See 3–122.
Transferred. See 3–116.
Withdrawn and replaced
newer version.
Transferred. See 3–139.
Reaffirmation. Extent of Recognition. Transferred. See 3–123.
Transferred. See 3–132.
Transferred. See 3–133.
Transferred. See 3–125.
Transferred. See 3–145.
Transferred. See 3–147.
D. Dental/Ear, Nose, and Throat (ENT)
4–50 ..................
4–89 ..................
........................
........................
4–91 ..................
........................
4–119 ................
........................
4–193 ................
........................
4–230 ................
........................
4–235 ................
........................
4–237 ................
........................
ADA Specification No. 18: 1992 Alginate Impression Materials .............
ANSI/ADA Specification No. 53 Reaffirmed by ANSI: August 2013
Polymer-Based Crown and Bridge Materials.
ANSI/ADA Standard No. 80/ISO 7491:2000 Reaffirmed by ANSI: May
2013 Dental Materials—Determination of Color Stability.
ANSI/ADA Specification No. 82:1998/ISO 13716:1999 Reaffirmed by
ANSI: January 2009 Dental Reversible/Irreversible Hydrocolloid Impression Material Systems.
ANSI/ADA Standard No. 15–2008/ISO 22112:2005 Reaffirmed by
ANSI: May 2013 Artificial Teeth for Dental Prostheses.
ANSI/ADA Standard No. 30/ISO 3107:2011 Approved by ANSI: February 2013 Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol
Cements.
ANSI/ADA Standard No. 100/ISO 27020:2010 Approved by ANSI: November 2012 Orthodontic Brackets and Tubes.
ANSI/ADA Standard No.120–2009/ISO 20127:2005 Reaffirmed by
ANSI: September 8, 2014 Powered Toothbrushes.
Withdrawn. See 4–240.
Reaffirmation.
Transferred. See 4–241.
Withdrawn. See 4–240.
Transferred. See 4–151.
Transferred. See 4–198.
Transferred. See 4–218.
Transferred. See 4–238.
E. General I (Quality Systems/Risk Management) (QS/RM)
........................
5–70 ..................
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5–65 ..................
........................
5–92 ..................
........................
5–96 ..................
........................
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ANSI/AAMI/ISO 80369–1:2010 Small bore connectors for liquids and
gases in healthcare applications—Part 1: General requirements.
ANSI/AAMI/ISO 14971:2007/(R)2010 (Corrected 4 October 2007)
Medical devices—Application of risk management to medical devices.
ANSI/AAMI/IEC 60601–1–8:2006 and A1:2012 Medical Electrical
Equipment—Part 1–8: General requirements for basic safety and
essential performance—Collateral Standard: General requirements,
tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
ANSI/AAMI/IEC 62366–1:2015 Medical devices—Part 1: Application of
usability engineering to medical devices.
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Transferred. See 5–63.
Transferred. See 5–40.
Transferred. See 5–76.
Transferred. See 5–114.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
5–100 ................
........................
5–118 ................
........................
5–119 ................
........................
Title of standard 1
Change
ANSI/AAMI/ISO 80369–20:2015 Small-bore connectors for liquids and
gases in healthcare applications—Part 20: Common test methods.
ANSI/AAMI/ISO 15223–1:2016 Medical devices—Symbols to be used
with medical device labels, labelling and information to be supplied—Part 1: General requirements.
ANSI/AAMI/ISO 80369–5:2016 Small-bore connectors for liquids and
gases in healthcare applications—Part 5: Connectors for limb cuff
inflation applications.
Transferred. See 5–97.
Transferred. See 5–117.
Transferred. See 5–107.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19–2 ..................
........................
19–12 ................
........................
ANSI/AAMI/IEC 60601–1–2:2007 (R2012) Medical electrical equipment—Part 1–2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests.
ANSI/AAMI/IEC 60601–1–2:2014 Medical electrical equipment—Part
1–2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests.
Transferred. See 19–1.
Transferred. See 19–8.
G. General Hospital/General Plastic Surgery (GH/GPS)
6–401
6–178 ................
........................
6–214 ................
........................
6–217 ................
6–402
6–227 ................
........................
6–229 ................
........................
6–232 ................
6–403
6–230 ................
........................
6–235 ................
........................
6–270 ................
........................
6–304 ................
6–404
6–307 ................
6–405
6–323 ................
6–406
6–337 ................
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6–149 ................
........................
ASTM D7160–16 Standard Practice for Determination of Expiration
Dating for Medical Gloves.
ASTM D6124–06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves.
ASTM D6355–07 (Reapproved 2017) Standard Test Method for
Human Repeat Insult Patch Testing of Medical Glove.
ASTM F1670/F1670M–17 Standard Test Method for Resistance of
Materials Used in Protective Clothing to Penetration by Synthetic
Blood.
ANSI/AAMI/IEC 60601–2–21:2009 Medical electrical equipment—Part
2–21: Particular requirements for the basic safety and essential performance of infant radiant warmers.
ANSI/AAMI/IEC 60601–2–2:2009 Medical electrical equipment—Part
2–2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment.
ISO 80601–2–56 Second edition 2017–03 Medical electrical equipment—Part 2–56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature
measurement.
ANSI/AAMI/IEC 60601–2–19:2009 Medical electrical equipment—Part
2–19: Particular requirements for the basic safety and essential performance of infant incubators.
ANSI/AAMI/IEC 60601–2–50:2009 Medical electrical equipment—Part
2–50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment.
ASTM F1840–10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles.
ISO 7886–1 Second edition 2017–05 Sterile hypodermic syringes for
single use—Part 1: Syringes for manual use.
IEC 80601–2–59 Edition 2.0 2017–09 Medical electrical equipment—
Part 2–59: Particular requirements for the basic safety and essential
performance of screening thermographs for human febrile temperature screening.
ASTM F1862/F1862M–17 Standard Test Method for Resistance of
Medical Face Masks to Penetration by Synthetic Blood (Horizontal
Projection of Fixed Volume at a Known Velocity).
ANSI/AAMI/IEC 60601–2–20:2009 Medical electrical equipment—Part
2–20: Particular requirements for the basic safety and essential performance of transport incubators [Including AMENDMENT 1 (2016)].
Withdrawn and
newer version.
Reaffirmation.
replaced
with
replaced
with
Reaffirmation.
Withdrawn and
newer version.
Transferred. See 6–388.
Transferred. See 6–389.
Withdrawn and
newer version.
replaced
Transferred. See 6–385.
Transferred. See 6–387.
Reaffirmation.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
Withdrawn and
newer version.
replaced
with
Transferred. See 6–386.
H. In Vitro Diagnostics (IVD)
7–271 ................
VerDate Sep<11>2014
........................
17:19 Jun 06, 2018
CLSI M100 27th Edition Performance Standards for Antimicrobial Susceptibility Testing.
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with
Extent of recognition.
07JNN1
26470
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
I. Materials
8–113 ................
........................
8–337 ................
........................
8–356 ................
........................
8–446 ................
8–460
ASTM F1147–05 (Reapproved 2017) e1 Standard Test Method for
Tension Testing of Calcium Phosphate and Metallic Coatings.
ASTM F621–12 (Reapproved 2017) Standard Specification for Stainless Steel Forgings for Surgical Implants.
ASTM F67–13 (Reapproved 2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250,
UNS R50400, UNS R50550, UNS R50700).
ASTM F2848–17 Standard Specification for Medical-Grade Ultra-High
Molecular Weight Polyethylene Yarns.
Reaffirmation.
Reaffirmation.
Reaffirmation.
Withdrawn and replaced with
newer version. Extent of recognition.
J. Nanotechnology
No new entries at this time
K. Neurology
17–1 ..................
........................
17–8 ..................
17–15
17–10 ................
........................
17–11 ................
17–16
ANSI/AAMI NS28:1988/(R)2015 Intracranial pressure monitoring devices.
ISO 14708–3 Second edition 2017–04 Implants for surgery—Active
implantable medical devices—Part 3: Implantable neurostimulators.
ANSI/AAMI/ISO 14708–3:2008/(R)2011 Implants for surgery—Active
implantable medical devices—Part 3: Implantable neurostimulators.
IEC 60601–2–10 Edition 2.1 2016–04 Medical electrical equipment—
Part 2–10: Particular requirements for the basic safety and essential
performance of nerve and muscle stimulators.
Reaffirmation. Extent of recognition.
Withdrawn and replaced with
newer version.
Withdrawn.
Withdrawn and
newer version.
replaced
with
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9–64 ..................
........................
9–66 ..................
........................
9–81 ..................
........................
9–91 ..................
........................
9–91 ..................
9–114
9–93 ..................
9–115
9–103 ................
........................
9–104 ................
........................
9–105 ................
........................
9–106 ................
........................
9–107 ................
........................
ANSI/AAMI/IEC 60601–2–2:2009 Medical electrical equipment—Part
2–2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency
surgical accessories.
ANSI/AAMI/ISO
8638:2010
Cardiovascular
implants
and
extracorporeal blood circuit for hemodialyzers, hemodiafilters, and
hemofilters.
ANSI/AAMI/IEC 60601–2–16:2012 Medical electrical equipment—Part
2–16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment.
ANSI/AAMI/ISO
8637:2010
Cardiovascular
implants
and
extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters,
and hemoconcentrators [Including AMENDMENT 1 (2013)].
IEC 60601–2–18: Edition 3.0 2009–08, medical electrical equipment—
part 2–18: particular requirements for the basic safety and essential
performance of endoscopic equipment.
ISO 25841 Third edition 2017–08 Female condoms—Requirements
and test methods.
ANSI/AAMI/ISO 26722:2014 Water treatment equipment for
haemodialysis applications and related therapies.
ANSI/AAMI/ISO 13958:2014 Concentrates for hemodialysis and related therapies.
ANSI/AAMI/ISO 13959:2014 Water for hemodialysis and related therapies.
ANSI/AAMI/ISO 11663:2014 Quality of dialysis fluid for hemodialysis
and related therapies.
ANSI/AAMI/ISO 23500:2014 Guidance for the preparation and quality
management of fluids for hemodialysis and related therapies.
Withdrawn. Duplicate recognition.
See 6–229.
Transferred. See 9–89.
Transferred. See 9–80
Transferred. See 9–92.
Withdrawn and replaced with new
recognition number.
Withdrawn and replaced
newer version.
Transferred. See 9–101.
with
Transferred. See 9–97.
Transferred. See 9–98.
Transferred. See 9–100.
Transferred. See 9–99.
sradovich on DSK3GMQ082PROD with NOTICES
M. Ophthalmic
10–43 ................
10–105
10–46 ................
10–106
10–54 ................
10–107
10–80 ................
10–108
VerDate Sep<11>2014
17:19 Jun 06, 2018
ISO 11979–8 Third edition 2017–04 Ophthalmic Implants—Intraocular
lenses—Part 8: Fundamental requirements.
ISO 18369–3 Second edition 2017–08 Ophthalmic optics—Contact
lenses—Part 3: Measurement methods.
ISO 18369–4 Second edition 2017–08 Ophthalmic optics—Contact
lenses—Part 4: Physicochemical properties of contact lens materials.
ISO 18369–2 Third edition 2017–08 Ophthalmic optics—Contact
lenses—Part 2: Tolerances.
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Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
07JNN1
replaced
with
replaced
with
replaced
with
replaced
with
26471
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
10–83 ................
Replacement
recognition
No.
10–109
Title of standard 1
Change
ISO 18369–1 Second edition 2017–08 Ophthalmic optics—Contact
lenses—Part 1: Vocabulary, classification system and recommendations for labelling specifications.
Withdrawn and
newer version.
replaced
with
N. Orthopedic
11–259 ..............
........................
ASTM F2887—12 Standard Specification for Total Elbow Prostheses ..
Withdrawn. See 11–321.
O. Physical Medicine
16–200 ..............
16–201
ISO 7176–19 Second edition 2008–07–15 AMENDMENT 1 2015–11–
15. Wheelchairs—Part 19: Wheeled mobility devices for use as
seats in motor vehicles [Including AMENDMENT 1 (2015)].
Withdrawn and replaced with a
newer version including amendment.
P. Radiology
12–139 ..............
........................
12–202 ..............
12–308
12–204 ..............
12–309
12–251 ..............
12–310
12–252 ..............
12–311
12–227 ..............
12–312
12–276 ..............
12–313
12–155 ..............
12–314
12–192 ..............
12–315
12–258 ..............
12–316
NEMA UD 2–2004 (R2009) Acoustic Output Measurement Standard
for Diagnostic Ultrasound Equipment, Revision 3.
IEC 60601–2–43 Edition 2.1 2017–05 CONSOLIDATED VERSION
Medical electrical equipment—Part 2–43: Particular requirements for
the safety and essential performance of X-Ray Equipment for interventional procedures.
IEC 60601–2–28 Edition 3.0 2017–06 Medical electrical equipment—
Part 2–28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis.
IEC 60601–2–63 Edition 1.1 2017–07 CONSOLIDATED VERSION
Medical electrical equipment—Part 2–63: Particular requirements for
the basic safety and essential performance of dental extra-oral XRay equipment.
IEC 60601–2–65 Edition 1.1 2017–05 CONSOLIDATED VERSION
Medical electrical equipment—Part 2–65: Particular requirements for
the basic safety and essential performance of dental intra-oral XRay equipment.
IEC 61391–1 Edition 1.1 2017–07 CONSOLIDATED VERSION
Ultrasonics—Pulse-echo scanners—Part 1: Techniques for calibrating spatial measurement systems and measurement of system
point-spread function response.
IEC TS 62462 Edition 2.0 2017–07 Ultrasonics—Output test—Guidance for the maintenance of ultrasound physiotherapy systems.
ISO 11554 Fourth edition 2017–07 Optics and photonics—Lasers and
laser-related equipment—Test methods for laser beam power, energy and temporal characteristics.
NEMA Standards Publication MS 8–2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems.
IEC 62359 Edition 2.1 2017–09 CONSOLIDATED VERSION
Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.
Withdrawn. Duplicate recognition.
See 12–105.
Withdrawn and replaced with
newer version.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Q. Software/Informatics
........................
13–41 ................
sradovich on DSK3GMQ082PROD with NOTICES
13–39 ................
........................
13–43 ................
........................
13–45 ................
........................
VerDate Sep<11>2014
17:19 Jun 06, 2018
ANSI/AAMI/IEC 80001–1:2010 Application of risk management for IT
Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.
ANSI/AAMI/IEC TIR80001–2–1:2012 Application of risk management
for IT-networks incorporating medical devices—Part 2–1: Step by
step risk management of medical IT-networks; Practical applications
and examples.
ANSI/AAMI/IEC TIR80001–2–2:2012 Technical Information Report Application of risk management for IT-networks incorporating medical
devices—Part 2–2: Guidance for the disclosure and communication
of medical device security needs, risks and controls.
ANSI/AAMI/IEC TIR80001–2–3:2012 Technical Information Report Application of risk management for IT-networks incorporating medical
devices—Part 2–3: Guidance for wireless networks.
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Transferred. See 13–38.
Transferred. See 13–40.
Transferred. See 13–42.
Transferred. See 13–44.
07JNN1
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
13–64 ................
........................
Title of standard 1
Change
ANSI/AAMI/IEC TIR80001–2–4:2012 Technical Information Report Application of risk management for IT-networks incorporating medical
devices—Part 2–4: General implementation guidance for healthcare
delivery organizations.
Transferred. See 13–63.
R. Sterility
........................
14–222 ..............
........................
14–227 ..............
........................
14–238 ..............
........................
14–261 ..............
........................
14–274 ..............
........................
14–278 ..............
........................
14–285 ..............
........................
14–287 ..............
........................
14–291 ..............
........................
14–295 ..............
........................
14–298 ..............
........................
14–330 ..............
14–510
14–339 ..............
........................
14–348 ..............
........................
14–349 ..............
........................
14–350 ..............
........................
14–351 ..............
........................
14–358 ..............
sradovich on DSK3GMQ082PROD with NOTICES
14–221 ..............
........................
14–376 ..............
........................
14–387 ..............
........................
14–425 ..............
........................
VerDate Sep<11>2014
17:19 Jun 06, 2018
ANSI/AAMI/ISO TIR 11139:2006 Sterilization of health care products—
Vocabulary.
ANSI/AAMI/ISO 18472:2006/(R)2010 Sterilization of health care products—Biological and chemical indicators—Test equipment.
ANSI/AAMI/ISO 11737–1:2006 (R)2011 Sterilization of health care
products—Microbiological methods—Part 1: Determination of the
population of microorganisms on product.
ANSI/AAMI/ISO 11140–5:2007/(R)2012 Sterilization of health care
products—Chemical indicators—Part 5: Class 2 indicators for Bowie
and Dick air removal test sheets and packs.
ANSI/AAMI/ISO 17665–1:2006/(R)2013 Sterilization of health care
products—Moist heat—Part 1: Requirements for the development,
validation, and routine control of a sterilization process for medical
devices.
ANSI/AAMI/ISO 15882:2008/(R)2013 Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results.
ANSI/AAMI/ISO 10993–7:2008(R)2012 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals.
ANSI/AAMI/ISO 14161:2009/(R)2014 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results.
ANSI/AAMI/ISO 11737–2:2009/(R)2014 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed
in the definition, validation and maintenance of a sterilization process.
ANSI/AAMI/ISO 14937:2009/(R)2013 Sterilization of health care products—General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices.
ANSI/AAMI ST81:2004/(R)2016 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of
resterilizable medical devices.
ANSI/AAMI/ISO 11137–3:2006/(R)2010 Sterilization of health care
products—Radiation—Part 3: Guidance on dosimetric aspects.
ISO 11137–3 Second edition 2017–06 Sterilization of health care
products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control.
ANSI/AAMI/ISO 20857:2010/(R)2015 Sterilization of health care products—Dry heat—Requirements for the development, validation and
routine control of a sterilization process for medical devices.
ANSI/AAMI/ISO 13408–2:2003/(R)2013 Aseptic processing of health
care products—Part 2: Filtration.
ANSI/AAMI/ISO 13408–3:2006/(R)2015 Aseptic processing of health
care products—Part 3: Lyophilization.
ANSI/AAMI/ISO 13408–4:2005/(R)2014 Aseptic processing of health
care products—Part 4: Clean-in-place technologies.
ANSI/AAMI/ISO 13408–5:2006/(R)2015 Aseptic processing of health
care products—Part 5: Sterilization in place.
ANSI/AAMI/ISO 14160:2011/(R)2016 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for
characterization, development, validation and routine control of a
sterilization process for medical devices.
ANSI/AAMI/ISO TIR 17665–2:2009 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI/
AAMI/ISO 17665–1.
ANSI/AAMI/ISO 13408–7:2012 Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products.
ANSI/AAMI/ISO 13408–6:2005/(R) 2013 & A1:2013 Aseptic processing of health care products—Part 6: Isolator systems [Including
AMENDMENT1 (2013)].
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Transferred. See 14–325.
Transferred. See 14–354.
Transferred. See 14–407.
Transferred. See 14–332.
Transferred. See 14–333.
Transferred. See 14–334.
Transferred. See 14–408.
Transferred. See 14–336.
Transferred. See 14–327.
Transferred. See 14–337.
Reaffirmation.
Withdrawn. See 14–510.
Withdrawn and
newer version.
replaced
Transferred. See 14–340.
Transferred. See 14–138.
Transferred. See 14–239.
Transferred. See 14–191.
Transferred. See 14–240.
Transferred. See 14–361.
Transferred. See 14–277.
Transferred. See 14–388.
Transferred. See 14–424.
07JNN1
with
26473
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
14–426 ..............
........................
14–438 ..............
........................
14–439 ..............
14–511
14–457 ..............
........................
14–458 ..............
........................
14–459 ..............
........................
14–461 ..............
........................
14–479 ..............
........................
Title of standard 1
Change
ANSI/AAMI/ISO 13408–1:2008 (R2011) Aseptic processing of health
care
products—Part
1:
General
requirements
[Including
AMENDMENT1 (2013)].
ANSI/AAMI/ISO 11137–2:2013 Sterilization of health care products—
Radiation—Part 2: Establishing the sterilization dose.
ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization
and sterility assurance in health care facilities.
ANSI/AAMI/ISO 11607–1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile
barrier systems and packaging [Including AMENDMENT 1 (2013)].
ANSI/AAMI/ISO 11607–2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming,
sealing and assembly processes [Including AMENDMENT 1 (2013)].
ANSI/AAMI/ISO 11140–1:2014 Sterilization of health care products—
Chemical indicators—Part 1: General requirements.
ANSI/AAMI/ISO 11137–1:2006/(R)2010 Sterilization of health care
products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
[Including AMENDMENT 1 (2013)].
ANSI/AAMI/ISO 11135:2014 Sterilization of health care products—
Ethylene oxide—Requirements for development, validation and routine control of a sterilization process for medical devices.
Transferred. See 14–427.
Transferred. See 14–409.
Withdrawn and replaced
newer version.
Transferred. See 14–454.
with
Transferred. See 14–455.
Transferred. See 14–460.
Transferred. See 14–428.
Transferred. See 14–452.
S. Tissue Engineering
15–17 ................
........................
15–23 ................
........................
15–37 ................
15–51
15–42 ................
15–52
1 All
ASTM F2311–08 Standard Guide for Classification of Therapeutic Skin
Substitutes.
ASTM F2739–08 Standard Guide for Quantitating Cell Viability within
Biomaterial Scaffolds.
ASTM F2347–15 Standard Guide for Characterization and Testing of
Hyaluronan as Starting Materials Intended for Use in Biomedical
and Tissue Engineered Medical Product Applications.
ASTM F2064–17 Standard Guide for Characterization and Testing of
Alginates as Starting Materials Intended for Use in Biomedical and
Tissue Engineered Medical Product Applications.
Withdrawn.
Withdrawn. See 15–50.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In table 2, FDA provides the listing of
new entries and consensus standards
added as modifications to the list of
recognized standards under Recognition
List Number: 049.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Title of standard 1
Recognition No.
Reference No. and Date
A. Anesthesiology
1–131 .................
Medical suction equipment—Part 1: Electrically powered suction equipment ..........................
1–132 .................
Medical suction equipment—Part 2: Manually powered suction equipment ............................
1–133 .................
Medical suction equipment—Part 3: Suction equipment powered from
pressure gas source.
Biocompatibility evaluation of breathing gas pathways in healthcare
Evaluation and testing within a risk management process.
Biocompatibility evaluation of breathing gas pathways in healthcare
Tests for emissions of particulate matter.
Biocompatibility evaluation of breathing gas pathways in healthcare
Tests for emissions of volatile organic compounds.
Biocompatibility evaluation of breathing gas pathways in healthcare
Tests for leachables in condensate.
Medical electrical equipment—Part 2–74: Particular requirements for
sential performance of respiratory humidifying equipment.
1–134 .................
1–135 .................
sradovich on DSK3GMQ082PROD with NOTICES
1–136 .................
1–137 .................
1–138 .................
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applications—Part 1:
applications—Part 2:
applications—Part 3:
applications—Part 4:
basic safety and es-
E:\FR\FM\07JNN1.SGM
07JNN1
ISO 10079–1 Third Edition
2015–11–01.
ISO 10079–2 Third Edition
2014–05–01.
ISO 10079–3 Third Edition
2014–05–01.
ISO 18562–1 First edition
2017–03.
ISO 18562–2 First edition
2017–03.
ISO 18562–3 First edition
2017–03.
ISO 18562–4 First edition
2017–03.
ISO 80601–2–74 First edition
2017–05.
26474
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and Date
B. Biocompatibility
No new entries at this time
C. Cardiovascular
No new entries at this time
D. Dental/Ear, Nose, and Throat (ENT)
4–240 .................
Dentistry—Hydrocolloid impression materials ...........................................................................
4–241 .................
Dental materials—Determination of colour stability ..................................................................
ISO 21563 First edition 2013–
08–15.
ISO 7491 Second edition
2000–09–01.
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time
G. General Hospital/General Plastic Surgery (GH/GPS)
6–407 .................
Standard Specification for Adult Portable Bed Rails and Related Products ............................
ASTM F3186–17.
H. In Vitro Diagnostics (IVD)
7–274 .................
Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline .................
CLSI MM17–A Vol. 28 No. 9
(Replaces MM17–P Vol. 27
No. 21).
I. Materials
8–461 .................
8–462 .................
8–463 .................
8–464 .................
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable
Medical Devices.
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles ..................
Standard Guide for Additive Manufacturing—General Principles—Requirements for Purchased AM Parts.
Assessment of the safety of magnetic resonance imaging for patients with an active
implantable medical device.
ASTM F3208–17.
ASTM F3260–17.
ISO/ASTM 52901 First edition
2017–08.
ISO 10974 Second edition
2018.
J. Nanotechnology
18–9 ...................
18–10 .................
Nanotechnologies—Guidance on physico-chemical characterization of engineered
nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)].
Nanotechnologies—Endotoxin test on nanomaterial samples for in vitro systems—Limulus
amebocyte lysate (LAL) test.
ISO/TR 13014 First edition
2012–05–15.
ISO 29701 First edition 2010–
09–15.
K. Neurology
No new entries at this time
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9–115 .................
9–116 .................
Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies
based on self-reports.
Condoms—Guidance on clinical studies—Part 2: Female condoms, clinical function studies
based on self-reports.
ISO 29943–1 First edition
2017–07.
ISO 29943–2 First edition
2017–07.
sradovich on DSK3GMQ082PROD with NOTICES
M. Ophthalmic
10–110 ...............
Ophthalmic implants—Ophthalmic viscosurgical devices [Including AMENDMENT 1 (2017)]
N. Orthopedic
No new entries at this time
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ISO 15798 Third edition
2013–09–15 AMENDMENT
1 2017–05.
26475
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and Date
O. Physical Medicine
16–202 ...............
RESNA Standard for Wheelchairs Volume 4: Wheelchairs and Transportation ......................
RESNA WC–4:2017.
P. Radiology
No new entries at this time
Q. Software/Informatics
13–104 ...............
Software Cybersecurity for Network-Connectable Products, Part 2–1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems.
ANSI/UL 2900–2–1, First Edition September 1, 2017.
R. Sterility
No new entries at this time
S. Tissue Engineering
15–53 .................
15–54 .................
1 All
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular
Therapies.
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model.
ASTM F3207–17.
standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA
Recognized Consensus Standards in a
searchable database that may be
accessed at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA
will be incorporating the modifications
and revisions described in this notice
into the database and, upon publication
in the Federal Register, this recognition
of consensus standards will be effective.
FDA will be announcing additional
modifications and revisions to the list of
recognized consensus standards, as
needed, in the Federal Register once a
year, or more often if necessary.
Beginning with recognition list 049,
FDA will no longer include in the
database the CDRH Office and Division
associated with recognized standards,
Devices Affected, and Processes
Affected. Beginning with recognition
list 049 FDA will automatically
incorporate, upon publication, a U.S.
parallel adoption of an existing
recognized international standard.
sradovich on DSK3GMQ082PROD with NOTICES
ASTM F3206 –17.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
be considered, such recommendations
should contain, at a minimum, the
following information available at
https://www.fda.gov/MedicalDevices/
VerDate Sep<11>2014
17:19 Jun 06, 2018
Jkt 244001
DeviceRegulationandGuidance/
Standards/ucm123739.htm.
Dated: May 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12222 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1635]
Prescription Drug User Fee Act
Waivers for Fixed-Combination
Antiretroviral Drugs for the President’s
Emergency Plan for AIDS Relief; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Prescription Drug User Fee Act
Waivers for Fixed-Combination
Antiretroviral Drugs for the President’s
Emergency Plan for AIDS Relief.’’ This
draft guidance describes circumstances
under which an applicant may be
eligible for a barrier-to-innovation
waiver for some new drug applications
(NDAs) for fixed-combination versions
and single-entity versions of previously
approved antiretroviral therapies for the
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
treatment of human immunodeficiency
virus (HIV).
DATES: Submit either electronic or
written comments on the guidance
August 6, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26465-26475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12222]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 049
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 049'' (Recognition List Number: 049), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: These modifications to the list of recognized standards are
applicable June 7, 2018.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 049.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday. FDA will
consider any comments received in determining whether to amend the
current listing of modifications to the list of recognized standards,
Recognition List Number: 049.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the
[[Page 26466]]
``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 049 is available on
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
See section IV for electronic access to the searchable database for
the current list of FDA recognized consensus standards, including
Recognition List Number: 049 modifications and other standards related
information. Submit written requests for a single hard copy of the
document entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 049'' to Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8144.
FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In the Federal Register notice of February 25, 1998 (63 FR 9561),
FDA announced the availability of a guidance entitled ``Recognition and
Use of Consensus Standards.'' The notice described how FDA would
implement its standard recognition program and provided the initial
list of recognized standards. The guidance was updated in September
2007 and is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274.htm.
Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions of
the list of FDA Recognized Consensus Standards. Additional information
on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 049
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 049'' to identify the current
modifications.
In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
----------------------------------------------------------------------------------------------------------------
A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-86............................. .............. ISO 8185 Third edition 2008-06- Withdrawn. See 1-138.
15 (Corrected version),
Respiratory tract humidifiers
for medical use--Particular
requirements for respiratory
humidification systems.
1-95............................. .............. ISO 5366-3 Second edition 2001- Withdrawn. See 1-117.
08-15 Anaesthetic and
Respiratory Equipment--
Tracheostomy Tubes--Part 3:
Paediatric Tracheostomy Tubes
[Including TECHNICAL
CORRIGENDUM 1 (2003)].
1-107............................ .............. ANSI/AAMI/ISO 5356-1:2004 Transferred. See 1-62.
Anaesthetic and respiratory
equipment--Conical connectors--
Part 1: Cones and sockets.
1-109............................ .............. ANSI/AAMI/ISO 5362:2006 Transferred. See 1-75.
Anaesthetic reservoir bags.
1-121............................ 1-129 ISO 5359 Fourth edition 2014-10- Withdrawn and replaced with
01 Anaesthetic and respiratory newer version including
equipment--Low-pressure hose amendment.
assemblies for use with medical
gases [Including AMENDMENT 1
(2017)].
1-128............................ 1-130 ISO 18082 First edition 2014-06- Withdrawn and replaced with
15 Anaesthetic and respiratory newer version including
equipment--Dimensions of amendment.
noninterchangeable screw-
threaded (NIST) low-pressure
connectors for medical gases
[Including AMENDMENT 1 (2017)].
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-118............................ .............. ANSI/AAMI/ISO 10993-11:2006/ Transferred. See 2-176.
(R)2010 Biological evaluation
of medical devices--Part 11:
Tests for systemic toxicity.
2-120............................ .............. ANSI/AAMI/ISO 10993-6:2007/ Withdrawn.
(R)2014 Biological evaluation
of medical devices--Part 6:
Tests for local effects after
implantation.
2-153............................ .............. ANSI/AAMI/ISO 10993-5:2009/ Transferred. See 2-245.
(R)2014 Biological evaluation
of medical devices--Part 5:
Tests for in vitro cytotoxicity.
[[Page 26467]]
2-156............................ .............. ANSI/AAMI/ISO 10993-1:2009/ Transferred. See 2-220.
(R)2013 Biological evaluation
of medical devices--Part 1:
Evaluation and testing within a
risk management process.
2-163............................ .............. ANSI/AAMI/ISO 10993-9:2009/ Transferred. See 2-168.
(R)2014 Biological evaluation
of medical devices--Part 9:
Framework for identification
and quantification of potential
degradation products.
2-165............................ .............. ANSI/AAMI/ISO 10993-14:2001/(R) Transferred. See 2-170.
2011 Biological evaluation of
medical devices--Part 14:
Identification and
quantification of degradation
products form ceramics.
2-171............................ 2-249 ISO 10993-16 Third edition 2017- Withdrawn and replaced with
05 Biological evaluation of newer version.
medical devices--Part 16:
Toxicokinetic study design for
degradation products and
leachables.
2-172............................ .............. ANSI/AAMI/TIR 10993-19:2006 Transferred. See 2-167.
Biological evaluation of
medical devices--Part 19:
Physicochemical, morphological,
and topographical
characterization of materials.
2-173............................ .............. ANSI/AAMI/ISO 10993-10:2010/ Transferred. See 2-174.
(R)2014 Biological evaluation
of medical devices--Part 10:
Tests for irritation and skin
sensitization.
2-180............................ .............. ANSI/AAMI/ISO 10993-16:2010/ Withdrawn.
(R)2014 Biological evaluation
of medical devices--Part 16:
Toxicokinetic study design for
degradation products and
leachables from medical devices.
2-181............................ .............. ANSI/AAMI/ISO 14155:2011 Transferred. See 2-205.
Clinical investigation of
medical devices for human
subjects--Good clinical
practice [Including: Technical
Corrigendum 1 (2011)].
2-190............................ .............. ANSI/AAMI/ISO 10993-13:2010/ Transferred. See 2-169.
(R)2014 Biological evaluation
of medical devices--Part 13:
Identification and
quantification of degradation
products from polymeric medical
devices.
2-198............................ .............. ANSI/AAMI/ISO 10993-12:2012 Transferred. See 2-191.
Biological evaluation of
medical devices--Part 12:
Sample preparation and
reference materials.
2-207............................ 2-250 ASTM F756-17 Standard Practice Withdrawn and replaced with
for Assessment of Hemolytic newer version.
Properties of Materials.
2-221............................ .............. ANSI/AAMI/ISO 10993-2:2006 Transferred. See 2-222.
(R2014) Biological evaluation
of medical devices--Part 2:
Animal welfare requirements.
2-226............................ .............. ANSI/AAMI/ISO 10993-3:2014 Transferred. See 2-228.
Biological evaluation of
medical devices--Part 3: Tests
for genotoxicity,
carcinogenicity, and
reproductive toxicity.
2-229............................ 2-251 USP 40-NF35:2017 <87> Biological Withdrawn and replaced with
Reactivity Test, In Vitro-- newer version.
Direct Contact Test.
2-230............................ 2-252 USP 40-NF35:2017 <87> Biological Withdrawn and replaced with
Reactivity Test, In Vitro-- newer version.
Elution Test.
2-231............................ 2-253 USP 40-NF35:2017 <88> Biological Withdrawn and replaced with
Reactivity Tests, In Vivo. newer version.
2-232............................ 2-254 USP 40-NF35:2017 <151> Pyrogen Withdrawn and replaced with
Test (USP Rabbit Test). newer version. Extent of
Recognition.
2-234............................ .............. ANSI/AAMI/ISO 10993-4:2002/(R) Withdrawn.
2013 & A1:2006/(R)2013
Biological evaluation of
medical devices--Part 4:
Selection of tests for
interaction with blood
[Including AMENDMENT 1 (2006)].
2-236............................ .............. ANSI/AAMI/ISO 10993-17:2002(R) Transferred. See 2-237.
2012 Biological evaluation of
medical devices--Part 17:
Establishment of allowable
limits for leachable substances.
2-239............................ .............. ANSI/AAMI/ISO TIR 10993-20:2006 Transferred. See 2-240.
Biological Evaluation of
Medical Devices--Part 20:
Principles and methods for
immunotoxicology testing of
medical devices.
2-242............................ .............. ANSI/AAMI/ISO TIR 37137:2014 Transferred. See 2-241.
Cardiovascular biological
evaluation of medical devices--
Guidance for absorbable
implants.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-80............................. .............. ANSI/AAMI/ISO 81060-1:2007/ Transferred. See 3-96.
(R)2013 Non-invasive
sphygmomanometers--Part 1:
Requirements and test methods
for non-automated measurement
type.
3-83............................. .............. ANSI/AAMI/ISO 14708-5:2010 Transferred. See 3-92.
Implants for surgery--Active
implantable medical devices--
Part 5: Circulatory support
devices.
3-101............................ .............. ANSI/AAMI/IEC 60601-2-27:2011 Transferred. See 3-126.
Medical electrical equipment--
Part 2-27: Particular
requirements for the basic
safety and essential
performance of
electrocardiographic monitoring
equipment.
3-106............................ .............. ANSI/AAMI/IEC 60601-2-25:2011/ Transferred. See 3-105.
(R)2016 Medical electrical
equipment--Part 2-25:
Particular requirements for the
basic safety and essential
performance of
electrocardiographs.
[[Page 26468]]
3-109............................ .............. ANSI/AAMI/ISO 27186:2010 Active Transferred. See 3-89.
implantable medical devices--
Four-pole connector system for
implantable cardiac rhythm
management devices--Dimensional
and test requirements.
3-111............................ .............. ANSI/AAMI/ISO 25539-3:2011 Transferred. See 3-103.
Cardiovascular implants--
Endovascular devices--Part 3:
Vena cava filters.
3-112............................ .............. ANSI/AAMI/ISO 7199:2009 Transferred. See 3-124.
Cardiovascular implants and
artificial organs--Blood gas
exchangers (oxygenators).
3-117............................ .............. ANSI/AAMI/ISO 81060-2 Second Transferred. See 3-122.
edition 2013-05-01 Non-invasive
sphygmomanometers--Part 2:
Clinical validation of
automated measurement type.
3-120............................ .............. ANSI/AAMI/ISO 25539-2:2012 Transferred. See 3-116.
Cardiovascular implants--
Endovascular devices--Part 2:
Vascular stents.
3-124............................ 3-150 ISO 7199 Third edition 2016-11- Withdrawn and replaced with
15 Cardiovascular implants and newer version.
artificial organs--Blood-gas
exchangers (oxygenators).
3-128............................ .............. ANSI/AAMI/ISO 14117:2012 Active Transferred. See 3-139.
implantable medical devices--
Electromagnetic compatibility--
EMC test protocols for
implantable cardiac pacemakers,
implantable cardioverter
defibrillators, and cardiac
resynchronization devices.
3-130............................ 3-151 ANSI/AAMI/IEC 80601-2-30:2009 & Reaffirmation. Extent of
A1:2013/(R2016) Medical Recognition. Transferred.
electrical equipment--Part 2- See 3-123.
30: Particular requirements for
the basic safety and essential
performance of automated non-
invasive sphygmomanometers.
3-131............................ .............. ANSI/AAMI/ISO 27185:2012 Cardiac Transferred. See 3-132.
rhythm management devices--
Symbols to be used with cardiac
rhythm management device
labels, and information to be
supplied--General requirements.
3-140............................ .............. ANSI/AAMI/ISO 5840-3:2013 Transferred. See 3-133.
Cardiovascular implants--
Cardiac valve prostheses--Part
3: Heart valve substitutes
implanted by transcatheter
techniques.
3-141............................ .............. ANSI/AAMI/ISO 5841-3:2013 Transferred. See 3-125.
Implants for surgery--Cardiac
pacemakers--Part 3: Low-profile
connectors (IS-1) for
implantable pacemakers.
3-146............................ .............. ANSI/AAMI/ISO 5840-1:2015 Transferred. See 3-145.
Cardiovascular implants--
Cardiac valve prostheses--Part
1: General requirements.
3-148............................ .............. ANSI/AAMI/ISO 5840-2:2015 Transferred. See 3-147.
Cardiovascular implants--
Cardiac valve prostheses--Part
2: Surgically implanted heart
valve substitutes.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-50............................. .............. ADA Specification No. 18: 1992 Withdrawn. See 4-240.
Alginate Impression Materials.
4-89............................. .............. ANSI/ADA Specification No. 53 Reaffirmation.
Reaffirmed by ANSI: August 2013
Polymer-Based Crown and Bridge
Materials.
4-91............................. .............. ANSI/ADA Standard No. 80/ISO Transferred. See 4-241.
7491:2000 Reaffirmed by ANSI:
May 2013 Dental Materials--
Determination of Color
Stability.
4-119............................ .............. ANSI/ADA Specification No. Withdrawn. See 4-240.
82:1998/ISO 13716:1999
Reaffirmed by ANSI: January
2009 Dental Reversible/
Irreversible Hydrocolloid
Impression Material Systems.
4-193............................ .............. ANSI/ADA Standard No. 15-2008/ Transferred. See 4-151.
ISO 22112:2005 Reaffirmed by
ANSI: May 2013 Artificial Teeth
for Dental Prostheses.
4-230............................ .............. ANSI/ADA Standard No. 30/ISO Transferred. See 4-198.
3107:2011 Approved by ANSI:
February 2013 Dental Zinc Oxide/
Eugenol & Zinc Oxide/Non-
Eugenol Cements.
4-235............................ .............. ANSI/ADA Standard No. 100/ISO Transferred. See 4-218.
27020:2010 Approved by ANSI:
November 2012 Orthodontic
Brackets and Tubes.
4-237............................ .............. ANSI/ADA Standard No.120-2009/ Transferred. See 4-238.
ISO 20127:2005 Reaffirmed by
ANSI: September 8, 2014 Powered
Toothbrushes.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-65............................. .............. ANSI/AAMI/ISO 80369-1:2010 Small Transferred. See 5-63.
bore connectors for liquids and
gases in healthcare
applications--Part 1: General
requirements.
5-70............................. .............. ANSI/AAMI/ISO 14971:2007/(R)2010 Transferred. See 5-40.
(Corrected 4 October 2007)
Medical devices--Application of
risk management to medical
devices.
5-92............................. .............. ANSI/AAMI/IEC 60601-1-8:2006 and Transferred. See 5-76.
A1:2012 Medical Electrical
Equipment--Part 1-8: General
requirements for basic safety
and essential performance--
Collateral Standard: General
requirements, tests and
guidance for alarm systems in
medical electrical equipment
and medical electrical systems.
5-96............................. .............. ANSI/AAMI/IEC 62366-1:2015 Transferred. See 5-114.
Medical devices--Part 1:
Application of usability
engineering to medical devices.
[[Page 26469]]
5-100............................ .............. ANSI/AAMI/ISO 80369-20:2015 Transferred. See 5-97.
Small-bore connectors for
liquids and gases in healthcare
applications--Part 20: Common
test methods.
5-118............................ .............. ANSI/AAMI/ISO 15223-1:2016 Transferred. See 5-117.
Medical devices--Symbols to be
used with medical device
labels, labelling and
information to be supplied--
Part 1: General requirements.
5-119............................ .............. ANSI/AAMI/ISO 80369-5:2016 Small- Transferred. See 5-107.
bore connectors for liquids and
gases in healthcare
applications--Part 5:
Connectors for limb cuff
inflation applications.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-2............................. .............. ANSI/AAMI/IEC 60601-1-2:2007 Transferred. See 19-1.
(R2012) Medical electrical
equipment--Part 1-2: General
requirements for basic safety
and essential performance--
Collateral standard:
Electromagnetic compatibility--
Requirements and tests.
19-12............................ .............. ANSI/AAMI/IEC 60601-1-2:2014 Transferred. See 19-8.
Medical electrical equipment--
Part 1-2: General requirements
for basic safety and essential
performance--Collateral
Standard: Electromagnetic
disturbances--Requirements and
tests.
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-149............................ 6-401 ASTM D7160-16 Standard Practice Withdrawn and replaced with
for Determination of Expiration newer version.
Dating for Medical Gloves.
6-178............................ .............. ASTM D6124-06 (Reapproved 2017) Reaffirmation.
Standard Test Method for
Residual Powder on Medical
Gloves.
6-214............................ .............. ASTM D6355-07 (Reapproved 2017) Reaffirmation.
Standard Test Method for Human
Repeat Insult Patch Testing of
Medical Glove.
6-217............................ 6-402 ASTM F1670/F1670M-17 Standard Withdrawn and replaced with
Test Method for Resistance of newer version.
Materials Used in Protective
Clothing to Penetration by
Synthetic Blood.
6-227............................ .............. ANSI/AAMI/IEC 60601-2-21:2009 Transferred. See 6-388.
Medical electrical equipment--
Part 2-21: Particular
requirements for the basic
safety and essential
performance of infant radiant
warmers.
6-229............................ .............. ANSI/AAMI/IEC 60601-2-2:2009 Transferred. See 6-389.
Medical electrical equipment--
Part 2-2: Particular
requirements for the basic
safety and essential
performance of high frequency
surgical equipment.
6-232............................ 6-403 ISO 80601-2-56 Second edition Withdrawn and replaced with
2017-03 Medical electrical newer version.
equipment--Part 2-56:
Particular requirements for
basic safety and essential
performance of clinical
thermometers for body
temperature measurement.
6-230............................ .............. ANSI/AAMI/IEC 60601-2-19:2009 Transferred. See 6-385.
Medical electrical equipment--
Part 2-19: Particular
requirements for the basic
safety and essential
performance of infant
incubators.
6-235............................ .............. ANSI/AAMI/IEC 60601-2-50:2009 Transferred. See 6-387.
Medical electrical equipment--
Part 2-50: Particular
requirements for the basic
safety and essential
performance of infant
phototherapy equipment.
6-270............................ .............. ASTM F1840-10 (Reapproved 2016) Reaffirmation.
Standard Terminology for
Surgical Suture Needles.
6-304............................ 6-404 ISO 7886-1 Second edition 2017- Withdrawn and replaced with
05 Sterile hypodermic syringes newer version.
for single use--Part 1:
Syringes for manual use.
6-307............................ 6-405 IEC 80601-2-59 Edition 2.0 2017- Withdrawn and replaced with
09 Medical electrical newer version.
equipment--Part 2-59:
Particular requirements for the
basic safety and essential
performance of screening
thermographs for human febrile
temperature screening.
6-323............................ 6-406 ASTM F1862/F1862M-17 Standard Withdrawn and replaced with
Test Method for Resistance of newer version.
Medical Face Masks to
Penetration by Synthetic Blood
(Horizontal Projection of Fixed
Volume at a Known Velocity).
6-337............................ .............. ANSI/AAMI/IEC 60601-2-20:2009 Transferred. See 6-386.
Medical electrical equipment--
Part 2-20: Particular
requirements for the basic
safety and essential
performance of transport
incubators [Including AMENDMENT
1 (2016)].
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-271............................ .............. CLSI M100 27th Edition Extent of recognition.
Performance Standards for
Antimicrobial Susceptibility
Testing.
----------------------------------------------------------------------------------------------------------------
[[Page 26470]]
I. Materials
----------------------------------------------------------------------------------------------------------------
8-113............................ .............. ASTM F1147-05 (Reapproved 2017) Reaffirmation.
[egr]\1\ Standard Test Method
for Tension Testing of Calcium
Phosphate and Metallic Coatings.
8-337............................ .............. ASTM F621-12 (Reapproved 2017) Reaffirmation.
Standard Specification for
Stainless Steel Forgings for
Surgical Implants.
8-356............................ .............. ASTM F67-13 (Reapproved 2017) Reaffirmation.
Standard Specification for
Unalloyed Titanium, for
Surgical Implant Applications
(UNS R50250, UNS R50400, UNS
R50550, UNS R50700).
8-446............................ 8-460 ASTM F2848-17 Standard Withdrawn and replaced with
Specification for Medical-Grade newer version. Extent of
Ultra-High Molecular Weight recognition.
Polyethylene Yarns.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
No new entries at this time ...........................
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
17-1............................. .............. ANSI/AAMI NS28:1988/(R)2015 Reaffirmation. Extent of
Intracranial pressure recognition.
monitoring devices.
17-8............................. 17-15 ISO 14708-3 Second edition 2017- Withdrawn and replaced with
04 Implants for surgery--Active newer version.
implantable medical devices--
Part 3: Implantable
neurostimulators.
17-10............................ .............. ANSI/AAMI/ISO 14708-3:2008/ Withdrawn.
(R)2011 Implants for surgery--
Active implantable medical
devices--Part 3: Implantable
neurostimulators.
17-11............................ 17-16 IEC 60601-2-10 Edition 2.1 2016- Withdrawn and replaced with
04 Medical electrical newer version.
equipment--Part 2-10:
Particular requirements for the
basic safety and essential
performance of nerve and muscle
stimulators.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-64............................. .............. ANSI/AAMI/IEC 60601-2-2:2009 Withdrawn. Duplicate
Medical electrical equipment-- recognition. See 6-229.
Part 2-2: Particular
requirements for the basic
safety and essential
performance of high frequency
surgery equipment and high
frequency surgical accessories.
9-66............................. .............. ANSI/AAMI/ISO 8638:2010 Transferred. See 9-89.
Cardiovascular implants and
extracorporeal blood circuit
for hemodialyzers,
hemodiafilters, and hemofilters.
9-81............................. .............. ANSI/AAMI/IEC 60601-2-16:2012 Transferred. See 9-80
Medical electrical equipment--
Part 2-16: Particular
requirements for basic safety
and essential performance of
hemodialysis, hemodiafiltration
and hemofiltration equipment.
9-91............................. .............. ANSI/AAMI/ISO 8637:2010 Transferred. See 9-92.
Cardiovascular implants and
extracorporeal systems--
Hemodialyzers, hemodiafilters,
hemofilters, and
hemoconcentrators [Including
AMENDMENT 1 (2013)].
9-91............................. 9-114 IEC 60601-2-18: Edition 3.0 2009- Withdrawn and replaced with
08, medical electrical new recognition number.
equipment--part 2-18:
particular requirements for the
basic safety and essential
performance of endoscopic
equipment.
9-93............................. 9-115 ISO 25841 Third edition 2017-08 Withdrawn and replaced with
Female condoms--Requirements newer version.
and test methods.
9-103............................ .............. ANSI/AAMI/ISO 26722:2014 Water Transferred. See 9-101.
treatment equipment for
haemodialysis applications and
related therapies.
9-104............................ .............. ANSI/AAMI/ISO 13958:2014 Transferred. See 9-97.
Concentrates for hemodialysis
and related therapies.
9-105............................ .............. ANSI/AAMI/ISO 13959:2014 Water Transferred. See 9-98.
for hemodialysis and related
therapies.
9-106............................ .............. ANSI/AAMI/ISO 11663:2014 Quality Transferred. See 9-100.
of dialysis fluid for
hemodialysis and related
therapies.
9-107............................ .............. ANSI/AAMI/ISO 23500:2014 Transferred. See 9-99.
Guidance for the preparation
and quality management of
fluids for hemodialysis and
related therapies.
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-43............................ 10-105 ISO 11979-8 Third edition 2017- Withdrawn and replaced with
04 Ophthalmic Implants-- newer version.
Intraocular lenses--Part 8:
Fundamental requirements.
10-46............................ 10-106 ISO 18369-3 Second edition 2017- Withdrawn and replaced with
08 Ophthalmic optics--Contact newer version.
lenses--Part 3: Measurement
methods.
10-54............................ 10-107 ISO 18369-4 Second edition 2017- Withdrawn and replaced with
08 Ophthalmic optics--Contact newer version.
lenses--Part 4: Physicochemical
properties of contact lens
materials.
10-80............................ 10-108 ISO 18369-2 Third edition 2017- Withdrawn and replaced with
08 Ophthalmic optics--Contact newer version.
lenses--Part 2: Tolerances.
[[Page 26471]]
10-83............................ 10-109 ISO 18369-1 Second edition 2017- Withdrawn and replaced with
08 Ophthalmic optics--Contact newer version.
lenses--Part 1: Vocabulary,
classification system and
recommendations for labelling
specifications.
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-259........................... .............. ASTM F2887--12 Standard Withdrawn. See 11-321.
Specification for Total Elbow
Prostheses.
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-200........................... 16-201 ISO 7176-19 Second edition 2008- Withdrawn and replaced with
07-15 AMENDMENT 1 2015-11-15. a newer version including
Wheelchairs--Part 19: Wheeled amendment.
mobility devices for use as
seats in motor vehicles
[Including AMENDMENT 1 (2015)].
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-139........................... .............. NEMA UD 2-2004 (R2009) Acoustic Withdrawn. Duplicate
Output Measurement Standard for recognition. See 12-105.
Diagnostic Ultrasound
Equipment, Revision 3.
12-202........................... 12-308 IEC 60601-2-43 Edition 2.1 2017- Withdrawn and replaced with
05 CONSOLIDATED VERSION Medical newer version.
electrical equipment--Part 2-
43: Particular requirements for
the safety and essential
performance of X-Ray Equipment
for interventional procedures.
12-204........................... 12-309 IEC 60601-2-28 Edition 3.0 2017- Withdrawn and replaced with
06 Medical electrical newer version.
equipment--Part 2-28:
Particular requirements for the
basic safety and essential
performance of X-ray tube
assemblies for medical
diagnosis.
12-251........................... 12-310 IEC 60601-2-63 Edition 1.1 2017- Withdrawn and replaced with
07 CONSOLIDATED VERSION Medical newer version.
electrical equipment--Part 2-
63: Particular requirements for
the basic safety and essential
performance of dental extra-
oral X-Ray equipment.
12-252........................... 12-311 IEC 60601-2-65 Edition 1.1 2017- Withdrawn and replaced with
05 CONSOLIDATED VERSION Medical newer version.
electrical equipment--Part 2-
65: Particular requirements for
the basic safety and essential
performance of dental intra-
oral X-Ray equipment.
12-227........................... 12-312 IEC 61391-1 Edition 1.1 2017-07 Withdrawn and replaced with
CONSOLIDATED VERSION newer version.
Ultrasonics--Pulse-echo
scanners--Part 1: Techniques
for calibrating spatial
measurement systems and
measurement of system point-
spread function response.
12-276........................... 12-313 IEC TS 62462 Edition 2.0 2017-07 Withdrawn and replaced with
Ultrasonics--Output test-- newer version.
Guidance for the maintenance of
ultrasound physiotherapy
systems.
12-155........................... 12-314 ISO 11554 Fourth edition 2017-07 Withdrawn and replaced with
Optics and photonics--Lasers newer version.
and laser-related equipment--
Test methods for laser beam
power, energy and temporal
characteristics.
12-192........................... 12-315 NEMA Standards Publication MS 8- Withdrawn and replaced with
2016 Characterization of the newer version.
Specific Absorption Rate (SAR)
for Magnetic Resonance Imaging
Systems.
12-258........................... 12-316 IEC 62359 Edition 2.1 2017-09 Withdrawn and replaced with
CONSOLIDATED VERSION newer version.
Ultrasonics--Field
characterization--Test methods
for the determination of
thermal and mechanical indices
related to medical diagnostic
ultrasonic fields.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-39............................ .............. ANSI/AAMI/IEC 80001-1:2010 Transferred. See 13-38.
Application of risk management
for IT Networks incorporating
medical devices--Part 1: Roles,
responsibilities and activities.
13-41............................ .............. ANSI/AAMI/IEC TIR80001-2-1:2012 Transferred. See 13-40.
Application of risk management
for IT-networks incorporating
medical devices--Part 2-1: Step
by step risk management of
medical IT-networks; Practical
applications and examples.
13-43............................ .............. ANSI/AAMI/IEC TIR80001-2-2:2012 Transferred. See 13-42.
Technical Information Report
Application of risk management
for IT-networks incorporating
medical devices--Part 2-2:
Guidance for the disclosure and
communication of medical device
security needs, risks and
controls.
13-45............................ .............. ANSI/AAMI/IEC TIR80001-2-3:2012 Transferred. See 13-44.
Technical Information Report
Application of risk management
for IT-networks incorporating
medical devices--Part 2-3:
Guidance for wireless networks.
[[Page 26472]]
13-64............................ .............. ANSI/AAMI/IEC TIR80001-2-4:2012 Transferred. See 13-63.
Technical Information Report
Application of risk management
for IT-networks incorporating
medical devices--Part 2-4:
General implementation guidance
for healthcare delivery
organizations.
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
14-221........................... .............. ANSI/AAMI/ISO TIR 11139:2006 Transferred. See 14-325.
Sterilization of health care
products--Vocabulary.
14-222........................... .............. ANSI/AAMI/ISO 18472:2006/(R)2010 Transferred. See 14-354.
Sterilization of health care
products--Biological and
chemical indicators--Test
equipment.
14-227........................... .............. ANSI/AAMI/ISO 11737-1:2006 Transferred. See 14-407.
(R)2011 Sterilization of health
care products--Microbiological
methods--Part 1: Determination
of the population of
microorganisms on product.
14-238........................... .............. ANSI/AAMI/ISO 11140-5:2007/ Transferred. See 14-332.
(R)2012 Sterilization of health
care products--Chemical
indicators--Part 5: Class 2
indicators for Bowie and Dick
air removal test sheets and
packs.
14-261........................... .............. ANSI/AAMI/ISO 17665-1:2006/ Transferred. See 14-333.
(R)2013 Sterilization of health
care products--Moist heat--Part
1: Requirements for the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-274........................... .............. ANSI/AAMI/ISO 15882:2008/(R)2013 Transferred. See 14-334.
Sterilization of health care
products--Chemical indicators--
Guidance for selection, use and
interpretation of results.
14-278........................... .............. ANSI/AAMI/ISO 10993- Transferred. See 14-408.
7:2008(R)2012 Biological
evaluation of medical devices--
Part 7: Ethylene oxide
sterilization residuals.
14-285........................... .............. ANSI/AAMI/ISO 14161:2009/(R)2014 Transferred. See 14-336.
Sterilization of health care
products--Biological
indicators--Guidance for the
selection, use and
interpretation of results.
14-287........................... .............. ANSI/AAMI/ISO 11737-2:2009/ Transferred. See 14-327.
(R)2014 Sterilization of
medical devices--
Microbiological methods--Part
2: Tests of sterility performed
in the definition, validation
and maintenance of a
sterilization process.
14-291........................... .............. ANSI/AAMI/ISO 14937:2009/(R)2013 Transferred. See 14-337.
Sterilization of health care
products--General requirements
for characterization of a
sterilizing agent and the
development, validation and
routine control of a
sterilization process for
medical devices.
14-295........................... .............. ANSI/AAMI ST81:2004/(R)2016 Reaffirmation.
Sterilization of medical
devices--Information to be
provided by the manufacturer
for the processing of
resterilizable medical devices.
14-298........................... .............. ANSI/AAMI/ISO 11137-3:2006/ Withdrawn. See 14-510.
(R)2010 Sterilization of health
care products--Radiation--Part
3: Guidance on dosimetric
aspects.
14-330........................... 14-510 ISO 11137-3 Second edition 2017- Withdrawn and replaced with
06 Sterilization of health care newer version.
products--Radiation--Part 3:
Guidance on dosimetric aspects
of development, validation and
routine control.
14-339........................... .............. ANSI/AAMI/ISO 20857:2010/(R)2015 Transferred. See 14-340.
Sterilization of health care
products--Dry heat--
Requirements for the
development, validation and
routine control of a
sterilization process for
medical devices.
14-348........................... .............. ANSI/AAMI/ISO 13408-2:2003/ Transferred. See 14-138.
(R)2013 Aseptic processing of
health care products--Part 2:
Filtration.
14-349........................... .............. ANSI/AAMI/ISO 13408-3:2006/ Transferred. See 14-239.
(R)2015 Aseptic processing of
health care products--Part 3:
Lyophilization.
14-350........................... .............. ANSI/AAMI/ISO 13408-4:2005/ Transferred. See 14-191.
(R)2014 Aseptic processing of
health care products--Part 4:
Clean-in-place technologies.
14-351........................... .............. ANSI/AAMI/ISO 13408-5:2006/ Transferred. See 14-240.
(R)2015 Aseptic processing of
health care products--Part 5:
Sterilization in place.
14-358........................... .............. ANSI/AAMI/ISO 14160:2011/(R)2016 Transferred. See 14-361.
Sterilization of health care
products--Liquid chemical
sterilizing agents for single-
use medical devices utilizing
animal tissues and their
derivatives--Requirements for
characterization, development,
validation and routine control
of a sterilization process for
medical devices.
14-376........................... .............. ANSI/AAMI/ISO TIR 17665-2:2009 Transferred. See 14-277.
Sterilization of health care
products--Moist heat--Part 2:
Guidance on the application of
ANSI/AAMI/ISO 17665-1.
14-387........................... .............. ANSI/AAMI/ISO 13408-7:2012 Transferred. See 14-388.
Aseptic processing of health
care products--Part 7:
Alternative processes for
medical devices and combination
products.
14-425........................... .............. ANSI/AAMI/ISO 13408-6:2005/(R) Transferred. See 14-424.
2013 & A1:2013 Aseptic
processing of health care
products--Part 6: Isolator
systems [Including AMENDMENT1
(2013)].
[[Page 26473]]
14-426........................... .............. ANSI/AAMI/ISO 13408-1:2008 Transferred. See 14-427.
(R2011) Aseptic processing of
health care products--Part 1:
General requirements [Including
AMENDMENT1 (2013)].
14-438........................... .............. ANSI/AAMI/ISO 11137-2:2013 Transferred. See 14-409.
Sterilization of health care
products--Radiation--Part 2:
Establishing the sterilization
dose.
14-439........................... 14-511 ANSI/AAMI ST79:2017 Withdrawn and replaced with
Comprehensive guide to steam newer version.
sterilization and sterility
assurance in health care
facilities.
14-457........................... .............. ANSI/AAMI/ISO 11607-1:2006/ Transferred. See 14-454.
(R)2010 Packaging for
terminally sterilized medical
devices--Part 1: Requirements
for materials, sterile barrier
systems and packaging
[Including AMENDMENT 1 (2013)].
14-458........................... .............. ANSI/AAMI/ISO 11607-2:2006/ Transferred. See 14-455.
(R)2010 Packaging for
terminally sterilized medical
devices--Part 2: Validation
requirements for forming,
sealing and assembly processes
[Including AMENDMENT 1 (2013)].
14-459........................... .............. ANSI/AAMI/ISO 11140-1:2014 Transferred. See 14-460.
Sterilization of health care
products--Chemical indicators--
Part 1: General requirements.
14-461........................... .............. ANSI/AAMI/ISO 11137-1:2006/ Transferred. See 14-428.
(R)2010 Sterilization of health
care products--Radiation--Part
1: Requirements for
development, validation and
routine control of a
sterilization process for
medical devices [Including
AMENDMENT 1 (2013)].
14-479........................... .............. ANSI/AAMI/ISO 11135:2014 Transferred. See 14-452.
Sterilization of health care
products--Ethylene oxide--
Requirements for development,
validation and routine control
of a sterilization process for
medical devices.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-17............................ .............. ASTM F2311-08 Standard Guide for Withdrawn.
Classification of Therapeutic
Skin Substitutes.
15-23............................ .............. ASTM F2739-08 Standard Guide for Withdrawn. See 15-50.
Quantitating Cell Viability
within Biomaterial Scaffolds.
15-37............................ 15-51 ASTM F2347-15 Standard Guide for Withdrawn and replaced with
Characterization and Testing of newer version.
Hyaluronan as Starting
Materials Intended for Use in
Biomedical and Tissue
Engineered Medical Product
Applications.
15-42............................ 15-52 ASTM F2064-17 Standard Guide for Withdrawn and replaced with
Characterization and Testing of newer version.
Alginates as Starting Materials
Intended for Use in Biomedical
and Tissue Engineered Medical
Product Applications.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 049.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No.
Recognition No. Title of standard \1\ and Date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-131................ Medical suction equipment--Part ISO 10079-1
1: Electrically powered Third Edition
suction equipment. 2015-11-01.
1-132................ Medical suction equipment--Part ISO 10079-2
2: Manually powered suction Third Edition
equipment. 2014-05-01.
1-133................ Medical suction equipment--Part ISO 10079-3
3: Suction equipment powered Third Edition
from a vacuum or positive 2014-05-01.
pressure gas source.
1-134................ Biocompatibility evaluation of ISO 18562-1
breathing gas pathways in First edition
healthcare applications--Part 2017-03.
1: Evaluation and testing
within a risk management
process.
1-135................ Biocompatibility evaluation of ISO 18562-2
breathing gas pathways in First edition
healthcare applications--Part 2017-03.
2: Tests for emissions of
particulate matter.
1-136................ Biocompatibility evaluation of ISO 18562-3
breathing gas pathways in First edition
healthcare applications--Part 2017-03.
3: Tests for emissions of
volatile organic compounds.
1-137................ Biocompatibility evaluation of ISO 18562-4
breathing gas pathways in First edition
healthcare applications--Part 2017-03.
4: Tests for leachables in
condensate.
1-138................ Medical electrical equipment-- ISO 80601-2-74
Part 2-74: Particular First edition
requirements for basic safety 2017-05.
and essential performance of
respiratory humidifying
equipment.
------------------------------------------------------------------------
[[Page 26474]]
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-240................ Dentistry--Hydrocolloid ISO 21563 First
impression materials. edition 2013-08-
15.
4-241................ Dental materials--Determination ISO 7491 Second
of colour stability. edition 2000-09-
01.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-407................ Standard Specification for ASTM F3186-17.
Adult Portable Bed Rails and
Related Products.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-274................ Verification and Validation of CLSI MM17-A Vol.
Multiplex Nucleic Acid Assays; 28 No. 9
Approved Guideline. (Replaces MM17-
P Vol. 27 No.
21).
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-461................ Standard Guide for Selecting ASTM F3208-17.
Test Soils for Validation of
Cleaning Methods for Reusable
Medical Devices.
8-462................ Standard Test Method for ASTM F3260-17.
Determining the Flexural
Stiffness of Medical Textiles.
8-463................ Standard Guide for Additive ISO/ASTM 52901
Manufacturing--General First edition
Principles--Requirements for 2017-08.
Purchased AM Parts.
8-464................ Assessment of the safety of ISO 10974 Second
magnetic resonance imaging for edition 2018.
patients with an active
implantable medical device.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
18-9................. Nanotechnologies--Guidance on ISO/TR 13014
physico-chemical First edition
characterization of engineered 2012-05-15.
nanoscale materials for
toxicologic assessment
[Including CORRIGENDUM 1
(2012)].
18-10................ Nanotechnologies--Endotoxin ISO 29701 First
test on nanomaterial samples edition 2010-09-
for in vitro systems--Limulus 15.
amebocyte lysate (LAL) test.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-115................ Condoms--Guidance on clinical ISO 29943-1
studies--Part 1: Male condoms, First edition
clinical function studies 2017-07.
based on self-reports.
9-116................ Condoms--Guidance on clinical ISO 29943-2
studies--Part 2: Female First edition
condoms, clinical function 2017-07.
studies based on self-reports.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-110............... Ophthalmic implants--Ophthalmic ISO 15798 Third
viscosurgical devices edition 2013-09-
[Including AMENDMENT 1 (2017)]. 15 AMENDMENT 1
2017-05.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
[[Page 26475]]
O. Physical Medicine
------------------------------------------------------------------------
16-202............... RESNA Standard for Wheelchairs RESNA WC-4:2017.
Volume 4: Wheelchairs and
Transportation.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-104............... Software Cybersecurity for ANSI/UL 2900-2-
Network-Connectable Products, 1, First
Part 2-1: Particular Edition
Requirements for Network September 1,
Connectable Components of 2017.
Healthcare and Wellness
Systems.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
15-53................ Standard Guide for Assessing ASTM F3206 -17.
Medical Device
Cytocompatibility with
Delivered Cellular Therapies.
15-54................ Standard Guide for in vivo ASTM F3207-17.
Evaluation of Rabbit Lumbar
Intertransverse Process Spinal
Fusion Model.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA
will be incorporating the modifications and revisions described in this
notice into the database and, upon publication in the Federal Register,
this recognition of consensus standards will be effective. FDA will be
announcing additional modifications and revisions to the list of
recognized consensus standards, as needed, in the Federal Register once
a year, or more often if necessary. Beginning with recognition list
049, FDA will no longer include in the database the CDRH Office and
Division associated with recognized standards, Devices Affected, and
Processes Affected. Beginning with recognition list 049 FDA will
automatically incorporate, upon publication, a U.S. parallel adoption
of an existing recognized international standard.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the following information available at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.
Dated: May 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12222 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P
