1. The following
publications are hereby adopted by reference by the State Board of Health in
the forms most recently published, unless the Board gives notice, in accordance
with subsection 2, that the most recent edition or revision is not suitable for
use in this State:
(a) American National
Standard ANSI/AAMI ST79, "Comprehensive guide to steam sterilization and
sterility assurance in health care facilities," of the Association for the
Advancement of Medical Instrumentation. A copy of the standard may be obtained
from the Association for the Advancement of Medical Instrumentation at the
Internet address
http://my.aami.org/store for
the price of $200 for members and $346 for nonmembers.
(b) ASTM Standard F67, "Standard
Specification for Unalloyed Titanium, for Surgical Implant Applications," of
ASTM International. A copy of the standard may be obtained by mail from ASTM
International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken,
Pennsylvania 19428-2959, by telephone at (610) 832-9585 or at the Internet
address
http://www.astm.org, at a cost of
$45.
(c) ASTM Standard F136,
"Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications," of ASTM International.
A copy of the standard may be obtained by mail from ASTM International, 100
Barr Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania 19428-2959,
by telephone at (610) 832-9585 or at the Internet address
http://www.astm.org, at a cost of
$45.
(d) ASTM Standard F138,
"Standard Specification for Wrought 18Chromium-14Nickel-2.5M olybdenum
Stainless Steel Bar and Wire for Surgical Implants," of ASTM International. A
copy of the standard may be obtained by mail from ASTM International, 100 Barr
Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania 19428-2959, by
telephone at (610) 832-9585 or at the Internet address
http://www.astm.org, at a cost of
$45.
(e) ASTM Standard F754,
"Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet,
Tube and Rod Shapes Fabricated from Granular Molding Powders," of ASTM
International. A copy of the standard may be obtained by mail from ASTM
International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken,
Pennsylvania 19428-2959, by telephone at (610) 832-9585 or at the Internet
address
http://www.astm.org, at a cost of
$40.
(f) ISO 5832-1, "Implants for
surgery - Metallic materials - Part 1: Wrought stainless steel," of the
International Organization for Standardization. A copy of the standard may be
obtained from the American National Standards Institute, 25 West 43rd Street,
4th Floor, New York, New York 10036, by telephone at (212) 642-4900 or at the
Internet address http://www.webstore.ansi.org [File Link Not
Available], at a price of $36 for members and $45 for
nonmembers.
(g) ISO 5832-3
"Implants for surgery - Metallic materials - Part 3: Wrought titanium
6-aluminum 4-vanadium alloy," of the International Organization for
Standardization. A copy of the standard may be obtained from the American
National Standards Institute, 25 West 43rd Street, 4th Floor, New York, New
York 10036, by telephone at (212) 642-4900 or at the Internet address
http://www.webstore.ansi.org [File Link Not Available] , at a
price of $54.40 for members and $68.00 for nonmembers.
(h) ISO 10993-1, "Biological evaluation of
medical devices - Part 1: Evaluation and testing within a risk management
process," of the International Organization for Standardization. A copy of the
standard may be obtained from the American National Standards Institute, 25
West 43rd Street, 4th Floor, New York, New York 10036, by telephone at (212)
642-4900 or at the Internet address http://www.webstore.ansi.org [File
Link Not Available], at a price of $148.
(i) ISO 10993-6, "Biological evaluation of
medical devices - Part 6: Tests for local effects after implantation," of the
International Organization for Standardization. A copy of the standard may be
obtained from the American National Standards Institute, 25 West 43rd Street,
4th Floor, New York, New York 10036, by telephone at (212) 642-4900 or at the
Internet address http://www.webstore.ansi.org [File Link Not
Available] , at a price of $129.60 for members and $162.00 for
nonmembers.
(j) ISO 10993-10,
"Biological evaluation of medical devices - Part 10: Tests for irritation and
skin sensitization," of the International Organization for Standardization. A
copy of the standard may be obtained from the American National Standards
Institute, 25 West 43rd Street, 4th Floor, New York, New York 10036, by
telephone at (212) 642-4900 or at the Internet address
http://www.webstore.ansi.org [File Link Not Available] , at a
price of $167.20 for members and $209.00 for nonmembers.
(k)
United States Pharmacopeia -
National Formulary, published by the United States Pharmacopeial
Convention. A copy of this publication may be obtained from the United States
Pharmacopeial Convention, Customer Service Department, 7135 English Muffin Way,
Frederick, Maryland 271704, or at the Internet address
http://www.usp.org/store/products [File Link Not Available],
for the price of $850.
2. The State Board of Health will review each
edition or revision of the publications adopted by reference pursuant to
subsection 1 to ensure its suitability for the State. If the Board determines
that an edition or revision is not suitable for this State, it will hold a
public hearing to review its determination and give notice of that hearing
within 6 months after the date on which the edition or revision was published,
and give 30 days' notice of that hearing. If, after the hearing, the Board does
not change its determination, the Board will give notice within 30 days after
the hearing that the applicable addition or revision is not suitable for this
State within 30 days after the hearing. If the Board does not give such notice,
the edition or revision shall be deemed part of the publication adopted by
reference pursuant to subsection 1.
Added to
NAC by Bd. of Health by
R112-16A,
eff. 12/19/2017