[Federal Register Volume 67, Number 191 (Wednesday, October 2, 2002)]
[Notices]
[Pages 61893-61910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24954]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0530]
FDA Modernization Act of 1997: Modifications to the List of
Recognized Standards, Recognition List Number: 007
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA will recognize for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 007'' (recognition list number: 007), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: The recognition of standards announced in this document will
become effective October 2, 2002. Submit written comments concerning
this document at any time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of ``Modifications to the List of Recognized Standards,
Recognition List Number: 007'' to the Division of Small Manufacturers
Assistance (DSMA), Center for Devices and Radiological Health (CDRH)
(HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville,
MD 20850. Send two self-addressed adhesive labels to assist that office
in processing your requests, or fax your request to 301-443-8818.
Submit written comments concerning this document to the contact person
(see FOR FURTHER INFORMATION CONTACT). Identify comments with the
docket number found in brackets in the heading of this document. You
may access this document on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html. See section V of this document for electronic
access to the searchable database for the current list of ``FDA
Recognized Consensus Standards,'' including recognition list number:
007 modifications, and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4766, ext. 156.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 of the act 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 a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of guidance entitled
``Recognition and Use of Consensus Standards.'' This notice described
how FDA will implement its standards program recognizing the use of
certain standards and provided the initial list of recognized
standards.
In Federal Register notices published on October 16, 1998 (63 FR
55617); July 12, 1999 (64 FR 37546); November 15, 2000 (65 FR 69022);
May 7, 2001 (66 FR 23032), and January 14, 2002 (67 FR 1774), FDA
modified its initial list of recognized standards. These notices
described the addition, withdrawal, and revision of certain standards
recognized by FDA.
FDA maintains the agency's current list of ``FDA Recognized
Consensus Standards'' in a searchable database that may be accessed
directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the
modifications and minor revisions described in this notice into the
database and this recognition of consensus standards will be effective
upon publication in the Federal Register. FDA will announce additional
modifications and minor revisions to the list of recognized consensus
standards, as needed, in the Federal Register once a year, or more
often, if necessary.
For each of the recognized standards, FDA provides in the database
a supplementary information sheet that includes information such as:
1. Devices affected by the standard;
2. Processes affected by the standard (premarket notification
(510(k), premarket approval (PMA), investigational device exemption
(IDE), product development protocol (PDP), and quality systems
regulation (QSR));
3. Extent of recognition (all or part of the standard, for what
purpose the standard is recognized);
4. Related citations in the Code of Federal Regulations that
identify the devices covered;
5. Related product codes that are used by FDA to identify the
devices covered; and
6. Guidances relevant to the devices affected by the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 007
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the agency
[[Page 61894]]
will recognize for use in satisfying portions of premarket review
submissions for devices. FDA will incorporate these modifications in
the list of ``FDA Recognized Consensus Standards'' in the agency's
searchable database. FDA is also establishing two new categories of
recognized standards: (1) ``Materials'' and (2) ``tissue engineering''
standards. The tables below reflect the changes FDA is making to the
list of recognized standards. These changes include:
[sbull] Withdrawn and replaced with a newer version
[sbull] Withdrawn and transferred to materials
[sbull] Contact person
[sbull] Transition statement added to the extend of recognition
[sbull] Citations and product codes
[sbull] Withdrawn
[sbull] Title correction
[sbull] Product codes and relevant guidance
[sbull] Devices affected
[sbull] Devices affected and type of standard
The following tables are divided by standards categories, include
the two new categories of materials and tissue engineering standards,
and identify the old item number, the name of the standard, the
specific change, and the new replacement number, if any.
A. Biocompatibility
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
12 ASTM F813-01, Withdrawn and
Standard Practice replaced with
for Direct Contact newer version
Cell Culture 56
Evaluation of
Materials for
Medical Devices
------------------------------------------------------------------------
13 ASTM E895-84 Withdrawn and 57
(2001)e1, Standard replaced with
Test Method for Agar newer version
Diffusion Cell
Culture Screening
for Cytotoxicity
------------------------------------------------------------------------
46 USP 25--NF20, Withdrawn and 58
Biological Tests replaced with
<87, newer version
Biological
Reactivity Test, In
Vitro--Direct
Contact Test
------------------------------------------------------------------------
47 USP 25--NF20, Withdrawn and 59
Biological Tests replaced with
<88, newer version
Biological
Reactivity Test, In
Vitro--Elution Test
------------------------------------------------------------------------
48 USP 25--NF20, Withdrawn and 60
Biological Tests replaced with
<88, newer version
Biological
Reactivity Test, In
Vivo, Classification
of Plastics--Simple
Preparation
------------------------------------------------------------------------
49 USP 25--NF20, Withdrawn and 61
Biological Tests replaced with
<88, newer version
Biological
Reactivity Test, In
Vivo--Intracutaneous
Test
------------------------------------------------------------------------
50 USP 25--NF20, Withdrawn and 62
Biological Tests replaced with
<88, newer version
Biological
Reactivity Test, In
Vivo--Systemic
Injection Test
------------------------------------------------------------------------
55 ANSI/AAMI/ISO 10993- Withdrawn and 63
6:1995/(R)2001: replaced with
Biological newer version
evaluation of
medical devices--
Part 6: Test for
local effects after
implantation
------------------------------------------------------------------------
54 ANSI/AAMI/ISO 10993- Withdrawn and 64
5: Biological replaced with
evaluation of change in
medical devices-- extent of
Part 5: Tests for in recognition
vitro cytotoxicity
------------------------------------------------------------------------
B. Cardiovascular/Neurology
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
12 ASTM F961-96, Withdrawn and .............
Standard transferred
Specification for to materials
Cobalt-35 Nickel-20
Chromium-10
Molybdenum Alloy
Forgings for
Surgical Implants
[UNS R30035]
------------------------------------------------------------------------
21 ASTM F75-01, Standard Withdrawn and .............
Specification for transferred
Cobalt-28 Chromium-6 to materials
Molybdenum Alloy
Castings and Casting
Alloy for Surgical
Implant (UNS R30075)
------------------------------------------------------------------------
22 ASTM F90-01, Standard Withdrawn and .............
Specification for transferred
Wrought Cobalt-20 to materials
Chromium-15 Tungsten-
10 Nickel Alloy for
Surgical Implant
Applications (UNS
R30605)
------------------------------------------------------------------------
[[Page 61895]]
24 ASTM F560-98, Withdrawn and .............
Standard transferred
Specification for to materials
Unalloyed Tantalum
for Surgical Implant
Applications (UNS
R05200, UNS R05400)
------------------------------------------------------------------------
28 ASTM F1058-97, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought Cobalt-
Chromium-Nickel-
Molybdenum-Iron
Alloy for Surgical
Implant Applications
------------------------------------------------------------------------
34 ASTM F138-00, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought 18 Chromium-
14 Nickel-2.5
Molybdenum Stainless
Bar and Wire for
Surgical Implants
(UNS S31673)
------------------------------------------------------------------------
35 ASTM F562-00, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought Cobalt-35
Nickel-20 Chromium-
10 Molybdenum Alloy
for Surgical Implant
Applications
------------------------------------------------------------------------
36 ASTM F136-98e1, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought Titanium-6
Aluminum-4 Vanadium
ELI (Extra Low
Interstitial) Alloy
(UNS R56401) for
Surgical Implant
Applications
------------------------------------------------------------------------
C. Dental/ENT
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
01 ASTM F67-00, Standard Withdrawn ............
Specification for and
Unalloyed Titanium for transferred
Surgical Implant to
Applications (UNS R50250, materials
UNS R50550, UNS R50700)
------------------------------------------------------------------------
02 ASTM F75-01, Standard Withdrawn ............
Specification for Cobalt- and
28 Chromium-6 Molybdenum transferred
Alloy Castings and to
Casting Alloy for materials
Surgical Implant (UNS R
30075)
------------------------------------------------------------------------
03 ASTM F90-01, Standard Withdrawn ............
Specification for Wrought and
Cobalt-20 Chromium-15 transferred
Tungsten-10 Nickel Alloy to
for Surgical Implant materials
Applications (UNS R30605)
------------------------------------------------------------------------
04 ASTM F136-98e1, Standard Withdrawn ............
Specification for Wrought and
Titanium-6 Aluminum-4 transferred
Vanadium ELI (Extra Low to
Interstitial) Alloy (UNS materials
R56401) for Surgical
Implant Applications
------------------------------------------------------------------------
05 ASTM F138-00, Standard Withdrawn ............
Specification for Wrought and
18 Chromium-14 Nickel-2.5 transferred
Molybdenum Stainless Bar to
and Wire for Surgical materials
Implants (UNS S31673)
------------------------------------------------------------------------
06 ASTM F139-00, Standard Withdrawn ............
Specification for Wrought and
18 Chromium-14 Nickel-2.5 transferred
Molybdenum Stainless to
Steel Sheet and Strip for materials
Surgical Implants (UNS
S31673)
------------------------------------------------------------------------
07 ASTM F562-00, Standard Withdrawn ............
Specification for Wrought and
Cobalt-35 Nickel-20 transferred
Chromium-10 Molybdenum to
Alloy for Surgical materials
Implant Applications
------------------------------------------------------------------------
08 ASTM F620-00, Standard Withdrawn ............
Specification for Alpha and
Beta Titanium Alloy transferred
Forgings for Surgical to
Implants materials
------------------------------------------------------------------------
09 ASTM F621-97, Standard Withdrawn ............
Specification for and
Stainless Steel Forgings transferred
for Surgical Implants to
materials
------------------------------------------------------------------------
10 ASTM F688-00, Standard Withdrawn ............
Specification for Wrought and
Cobalt-35 Nickel-2.5 transferred
Molybdenum Alloy Plate, to
Sheet, and Foil for materials
Surgical Implants (UNS
R30035)
------------------------------------------------------------------------
[[Page 61896]]
11 ASTM F745-00, Standard Withdrawn ............
Specification for 18 and
Chromium-12.5 Nickel-2.5 transferred
Molybdenum Stainless to
Steel for Cast and materials
Solution-Annealed
Surgical Implant
Applications
------------------------------------------------------------------------
12 ASTM F799-99, Standard Withdrawn ............
Specification for Cobalt- and
28 Chromium-6 Molybdenum transferred
Alloy Forgings for to
Surgical Implants (UNS materials
R31537, R31538, R31539)
------------------------------------------------------------------------
13 ASTM F961-96, Standard Withdrawn ............
Specification for Cobalt- and
35 Nickel-20 Chromium-10 transferred
Molybdenum Alloy Forgings to
for Surgical Implants materials
[UNS R30035]
------------------------------------------------------------------------
14 ASTM F1088-87 (1992)e1, Withdrawn ............
Standard Specification and
for Beta-Tricalcium transferred
Phosphate for Surgical to
Implantation materials
------------------------------------------------------------------------
15 ASTM F1091-91(2000), Withdrawn ............
Standard Specification and
for Wrought Cobalt-20 transferred
Chromium-15 Tungsten-10 to
Nickel Alloy Surgical materials
Fixation Wire (UNS R
30605)
------------------------------------------------------------------------
16 ASTM F1108-97a, Standard Withdrawn ............
Specification for Ti6A14V and
Alloy Castings for transferred
Surgical Implants (UNS to
R56406) materials
------------------------------------------------------------------------
17 ASTM F1185-88(1993)e1, Withdrawn ............
Standard Specification and
for Composition of transferred
Ceramic Hydroxylapatite to
for Surgical Implants materials
------------------------------------------------------------------------
18 ASTM F1295-01, Standard Withdrawn ............
Specification for Wrought and
Titanium-6 Aluminum-7 transferred
Niobium Alloy for to
Surgical Implant materials
Applications (UNS R56700)
------------------------------------------------------------------------
19 ASTM F1314-01, Standard Withdrawn ............
Specification for Wrought and
Nitrogen Strengthened 22 transferred
Chromium-13 Nickel-5 to
Manganese-2.5 Molybdenum materials
Stainless Steel Alloy Bar
and Wire for Surgical
Implants (UNS S20910)
------------------------------------------------------------------------
20 ASTM F1341-99, Standard Withdrawn ............
Specification for and
Unalloyed Titanium Wire transferred
UNS R50250, UNS R50400, to
UNS R50500, UNS R50700, materials
for Surgical Implant
Applications
------------------------------------------------------------------------
21 ASTM F1350-01, Standard Withdrawn ............
Specification for Wrought and
18 Chromium-14 Nickel- transferred
2.5, Molybdenum Stainless to
Steel Surgical Fixation materials
Wire (UNS S31673)
------------------------------------------------------------------------
23 ASTM F1472-00, Standard Withdrawn ............
Specification for Wrought and
Titanium-6 Aluminum-4 transferred
Vanadium Alloy (UNS to
R56400) for Surgical materials
Implant Applications
------------------------------------------------------------------------
24 ASTM F1537-00, Standard Withdrawn ............
Specification for Wrought and
Cobalt-28-Chromium-6- transferred
Molybdenum Alloy for to
Surgical Implants (UNS materials
R31537, UNS R31538, and
UNS R31539)
------------------------------------------------------------------------
25 F1580-95e1, Standard Withdrawn ............
Specification for and
Titanium and Titanium-6% transferred
Aluminum-4% Vanadium to
Alloy Powders for materials
Coatings of Surgical
Implants
------------------------------------------------------------------------
26 ASTM F1586-02, Standard Withdrawn ............
Specification for Wrought and
Nitrogen Strengthened 21 transferred
Chromium-Nickel-3 to
Manganese-2.5 Molybdenum materials
Stainless Steel Bar for
Surgical Implants (UNS
S31675)
------------------------------------------------------------------------
27 ASTM F1609-95, Standard Withdrawn ............
Specification for Calcium and
Phosphate Coatings for transferred
Implantable materials to
materials
------------------------------------------------------------------------
28 ASTM F1713-96, Standard Withdrawn ............
Specification for Wrought and
Titanium-13 Niobium-13 transferred
Zirconium Alloy for to
Surgical Implant materials
Applications
------------------------------------------------------------------------
42 ANSI/ADA Specification No. Contact 42
3:1994, Dental Impression person
Compound
------------------------------------------------------------------------
[[Page 61897]]
44 ANSI/ADA Specification No. Contact 44
11:1968, Agar Impression person
Material
------------------------------------------------------------------------
45 ANSI/ADA Specification No. Contact 45
13:1981, Denture Cold- person
Curing Repair Resin
------------------------------------------------------------------------
48 ANSI/ADA Specification No. Contact 48
16:1989, Dental person
Impression Paste Zinc
Oxide Eugenol Type
------------------------------------------------------------------------
49 ANSI/ADA Specification No. Contact 49
17:1983, Denture Base person
Temporary Relining Resin
------------------------------------------------------------------------
50 ANSI/ADA Specification No. Contact 50
18:1992, Alginate person
Impression Materials
------------------------------------------------------------------------
51 ANSI/ADA Specification No. Contact 51
20:1968, Dental person
Duplicating Material
------------------------------------------------------------------------
52 ANSI/ADA Specification No. Contact 52
27:1993, Resin-Based person
Filling Materials
------------------------------------------------------------------------
53 ANSI/ADA Specification No. Contact 53
30:1990, Dental Zinc person
Oxide-Eugenol and Zinc
Oxide Non-Eugenol Cements
------------------------------------------------------------------------
55 ANSI/ADA Specification No. Contact 55
48:1983, Ultraviolet person,
Activator and Disclosing update to
Lights processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
56 ANSI/ADA Specification No. Contact 56
57:1993, Endodontic person,
Sealing Materials update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
59 ANSI/ADA Specification No. Withdrawn 91
80:2001, Color Stability and
Test Procedures replaced
with newer
version,
update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
60 ANSI/ADA Specification No. Contact 60
96:1994, Dental-Water- person,
Based Cements update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
62 ISO 1563:1990, Dental Contact 62
Alginate Impression person,
Material update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
63 ISO 1564:1995, Dental Contact 63
Aqueous Impression person,
Materials Based on Agar update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
64 ISO 3107:1998, Dental Zinc Contact 64
Oxide Eugenol Cements and person,
Zinc Oxide Non-Eugenol update to
Cements processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
65 ISO 3336:1993, Dentistry-- Contact 65
Synthetic Polymer Teeth person,
update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
66 ISO 4049:1998, Dentistry-- Contact 66
Resin-Based Filling person,
Materials update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
[[Page 61898]]
69 ISO 6872:1995, Amendment 1- Contact 69
1997 Dental Ceramic person,
update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
71 ISO 6876:1986, Dental Root Contact 71
Canal Sealing Materials person,
update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
72 ISO 6877:1995, Dental Root Contact 72
Canal Obturating Points person,
update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
80 ISO 9917:1991, Dental Contact 80
Water-Based Cements person,
update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
81 ISO 10139-1:1991, Contact 81
Dentistry--Resilient person,
Lining Materials for Update to
Removable Dentures Part CDRH
1: Short Term Materials Offices to
include OC/
DE2, and
update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
82 ISO 10477:1998, Dentistry-- Contact 82
Polymer-Based Crown and person,
Bridge Materials update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
85 ANSI/ADA Specification Contact 85
15:1999, Synthetic Resin person,
Teeth update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
86 ANSI/ADA Specification No. Contact 86
38:2000, Metal-Ceramic person,
System update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
87 ANSI/ADA Specification No. Contact 87
69:1999, Dental Ceramic person,
update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
88 ANSI/ADA Specification No. Contact 88
78:2000, Endodontic person
Obturating Points
------------------------------------------------------------------------
89 ANSI/ASA Specification No. Contact 89
53:1999, Polymer-Based Person,
Crown and Bridge Resins update to
processes
impacted to
include
quality
system
regulation
------------------------------------------------------------------------
D. General
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
28 IEC 60601-1-2 (Second Transition 28
Edition, 2001), statement
Medical Electrical added to the
Equipment--Part1: extent of
General Requirements recognition
for Safety;
Electomagnetic
Compatibility--Requi
rements and Tests
------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
[[Page 61899]]
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
13 ISO 595/1 First Citations and 13
Edition 1986-12-15, product codes
Reusable All Glass
or Metal-and-Glass
Syringes for Medical
Use, Part 1:
Dimensions
------------------------------------------------------------------------
49 ASTM D6355-98, Withdrawn .............
Standard Test Method
for Human Repeat
Insult Patch Testing
of Medical Gloves
------------------------------------------------------------------------
57 USP 24 <11, Sterile Water
for Injection
------------------------------------------------------------------------
62 ISO 8536-6, First Citations and 62
Edition, 1996-04-01, product codes
Infusion Equipment
for Medical Use--
Part 6: Freeze
Drying Closures for
Infusion Bottles
------------------------------------------------------------------------
63 ISO 8536-7, Second Citations and 63
Edition, 1999-09-01, product codes
Infusion Equipment,
Caps made of
Aluminum-Plastic
Combinations for
Infusion Bottles
------------------------------------------------------------------------
76 ISO 1135-4, Second Citations and 76
Edition, 1998-03-15, product codes
Transfusion
Equipment for
Medical Use--Part 4:
Transfusion Sets for
Single Use
------------------------------------------------------------------------
80 ASTM E1112-00, Contact person 80
Standards
Specification for
Electronic
Thermometers for
Intermittent
Determinations of
Patient Temperatures
------------------------------------------------------------------------
41 USP 25, Nonabsorbable Withdrawn and 82
Surgical Sutures replaced with
newer version
------------------------------------------------------------------------
50 ASTM D6319-00ae3, Withdrawn and 83
Standard replaced with
Specification for newer version
Nitrile Examination
Gloves for Medical
Application
------------------------------------------------------------------------
51 ASTM D6124-01, Withdrawn and 84
Standard Test Method replaced with
for Residual Powder newer version
on Medical Globes
------------------------------------------------------------------------
52 ASTM D5250-00e4, Withdrawn and 85
Standard replaced with
Specification for newer version
Poly (vinyl
chloride) Gloves for
Medical Application
------------------------------------------------------------------------
54 ASTM D3578-01ae2, Withdrawn and 86
Standard replaced with
Specification for newer version
Rubber Examination
Gloves
------------------------------------------------------------------------
55 ASTM D3577-01ae2, Withdrawn and 87
Standard replaced with
Specification for newer version
Rubber Surgical
Gloves
------------------------------------------------------------------------
56 USP 25 <11, Sterile Sodium replaced with
Chloride for newer version
Irrigation
------------------------------------------------------------------------
58 USP 25, Absorbable Withdrawn and 89
Surgical Sutures replaced with
newer version
------------------------------------------------------------------------
59 USP 25 <881, Tensile replaced with
Strength newer version
------------------------------------------------------------------------
60 USP 25 <861, Sutures-- replaced with
Diameter newer version
------------------------------------------------------------------------
61 USP 25 <871, Sutures Needle replaced with
Attachment newer version
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
Dental 01, Ortho ASTM F67-00, Standard Transferred 01
123 Specification for from dental/
Unalloyed Titanium for ENT and
Surgical Implant orthopaedic
Applications (UNS R50250, s
UNS R50550, UNS R 50700)
------------------------------------------------------------------------
[[Page 61900]]
Cardio 21, ASTM F75-01, Standard Transferred 02
Dental 02, Specification for Cobalt- from
Ortho 86 28 Chromium-6 Molybdenum cardiovascu
Alloy Castings and lar/
Casting Alloy for neurology
Surgical Implant (UNS dental/ENT
R30075) and
orthopaedic
s
------------------------------------------------------------------------
Cardio 22, ASTM F90-01, Standard Transferred 03
Dental 03, Specification for Wrought from
Ortho 87 Cobalt-20 Chromium-15 cardiovascu
Tungsten-10 Nickel Alloy lar
for Surgical Implant neurology,
Applications (UNS R30605) dental/ENT
and
orthopaedic
s
------------------------------------------------------------------------
Cardio 36, ASTM F136-98e1, Standard Transferred 04
Dental 04, Specification for Wrought from
Ortho 88 Titanium-6 Aluminum-4 cardiovascu
Vanadium ELI (Extra Low lar/
Interstitial) Alloy (UNS neurology,
R56401) for Surgical dental/ENT
Implant Applications and
orthopaedic
s
------------------------------------------------------------------------
Cardio 34, ASTM F138-00, Standard Transferred 05
Dental 05, Specification for Wrought from
Ortho 144 18 Chromium-14 Nickel-2.5 cardiovascu
Molybdenum Stainless Bar lar/
and Wire for Surgical neurology,
Implants (UNS S31673) dental/ENT
and
orthopaedic
s
------------------------------------------------------------------------
Dental 06, Ortho ASTM F139-00, Standard Transferred 06
125 Specification for Wrought from dental/
18 Chromium-14 Nickel-2.5 ENT and
Molybdenum Stainless orthopaedic
Steel Sheet and Strip for s
Surgical Implants (UNS
S31673)
------------------------------------------------------------------------
Cardio 24, Ortho ASTM F560-98, Standard Transferred 07
90 Specification for from
Unalloyed Tantalum for cardiovascu
Surgical Implant lar/
Applications (UNS R05200, neurology
UNS R05400) and
orthopaedic
s
------------------------------------------------------------------------
Cardio 35, ASTM F562-00, Standard Transferred 08
Dental 07, Specification for Wrought from
Ortho 127 Cobalt-35 Nickel-20 cardiovascu
Chromium-10 Molybdenum lar/
Alloy for Surgical neurology,
Implant Applications dental/ENT
and
orthopaedic
s
------------------------------------------------------------------------
Ortho 146 ASTM F603-00, Standard Transferred 10
Specification for High- from
Purity Dense Aluminum orthopaedic
Oxide for Surgical s
Implant Application
------------------------------------------------------------------------
Dental 08, Ortho ASTM F620-00, Standard Transferred 11
147 Specification for Alpha from dental/
Beta Titanium Alloy ENT and
Forgings for Surgical orthopaedic
Implants s
------------------------------------------------------------------------
Dental 09, Ortho ASTM F621-97, Standard Transferred 12
97 Specification for from dental/
Stainless Steel Forgings ENT and
for Surgical Implants orthopaedic
s
------------------------------------------------------------------------
Ortho 148 ASTM F648-00, Standard Transferred 13
Specification for Ultra- from
High-Molecular-Weight orthopaedic
Polyethylene Powder and s
Fabricated Form for
Surgical Implants
------------------------------------------------------------------------
Dental 10, Ortho ASTM F688-00, Standard Transferred 14
128 Specification for Wrought from dental/
Cobalt-35 Nickel-2.5 ENT and
Molybdenum Alloy Plate, orthopaedic
Sheet, and Foil for s
Surgical Implants (UNS
R30035)
------------------------------------------------------------------------
Dental 11, Ortho ASTM F745-00, Standard Transferred 15
129 Specification for 18 from dental/
Chromium-12.5 Nickel-2.5 ENT and
Molybdenum Stainless orthopaedic
Steel for Cast and s
Solution-Annealed
Surgical Implant
Applications
------------------------------------------------------------------------
Ortho 149 ASTM F746-87 (1999), Transferred 16
Standard Test Method for from
Pitting or Crevice orthopaedic
Corrosion of Metallic s
Surgical Implant
Materials
------------------------------------------------------------------------
Dental 12, Ortho ASTM F799-99, Standard Transferred 17
130 Specification for Cobalt- from dental/
28 Chromium-6 Molybdenum ENT and
Alloy Forgings for orthopaedic
Surgical Implants (UNS s
R31537, R31538, R31539)
------------------------------------------------------------------------
Ortho 27 ASTM F899-95, Standard Transferred 18
Specification for from
Stainless Steel Billet, orthopaedic
Bar, and Wire for s
Surgical Instruments
------------------------------------------------------------------------
Cardio 12, ASTM F961-96, Standard Transferred 19
Dental 13, Specification for Cobalt- from
Ortho 28 35 Nickel-20 Chromium-10 cardiovascu
Molybdenum Alloy Forgings lar/
for Surgical Implants neurology,
[UNS R30035] dental/ENT
and
orthopaedic
s
------------------------------------------------------------------------
[[Page 61901]]
Cardio 28 ASTM F1058-97, Standard Transferred 20
Specification for Wrought from
Cobalt-Chromium-Nickel- cardiovascu
Molybdenum-Iron Alloy for lar/
Surgical Implant neurology
Applications
------------------------------------------------------------------------
Dental 14, Ortho ASTM F1088-87 (1992)e1, Transferred 21
132 Standard Specification from dental/
for Beta-Tricalcium ENT and
Phosphate for Surgical orthopaedic
Implantation s
------------------------------------------------------------------------
Dental 15, Ortho ASTM F1091-91(2000), Transferred 22
151 Standard Specification from dental/
for Wrought Cobalt-20 ENT and
Chromium-15 Tungsten-10 orthopaedic
Nickel Alloy Surgical s
Fixation Wire (UNS R
30605)
------------------------------------------------------------------------
Dental 16, Ortho ASTM F1108-97a, Standard Transferred 23
133 Specification for Ti6A14V from dental/
Alloy Castings for ENT and
Surgical Implants (UNS orthopaedic
R56406) s
------------------------------------------------------------------------
Dental 17, Ortho ASTM F1185-88(1993)e1, Transferred 24
109 Standard Specification from dental/
for Composition of ENT and
Ceramic Hydroxylapatite orthopaedic
for Surgical Implants s
------------------------------------------------------------------------
Dental 18, Ortho ASTM F1295-01, Standard Transferred 25
134 Specification for Wrought from dental/
Titanium-6 Aluminum-7 ENT and
Niobium Alloy for orthopaedic
Surgical Implant s
Applications (UNS R56700)
------------------------------------------------------------------------
Dental 19, Ortho ASTM F1314-01, Standard Transferred 26
40 Specification for Wrought from dental/
Nitrogen Strengthened 22 ENT and
Chromium-13 Nickel-5 orthopaedic
Manganese-2.5 Molybdenum s
Stainless Steel Alloy Bar
and Wire for Surgical
Implants (UNS S20910)
------------------------------------------------------------------------
Dental 20, Ortho ASTM F1341-99, Standard Transferred 27
135 Specification for for dental/
Unalloyed Titanium Wire ENT and
UNS R50250, UNS R50400, orthopaedic
UNS R50500, UNS R50700, s
for Surgical Implant
Applications
------------------------------------------------------------------------
Dental 21, Ortho ASTM F1350-01, Standard Transferred 28
154 Specification for Wrought from dental/
18 Chromium-14 Nickel- ENT and
2.5, Molybdenum Stainless orthopaedic
Steel Surgical Fixation s
Wire (UNS S31673)
------------------------------------------------------------------------
Dental 23, Ortho ASTM F1472-00, Standard Transferred 29
136 Specification for Wrought from dental/
Titanium-6 Aluminum-4 ENT and
Vanadium Alloy (UNS orthopaedic
R56400) for Surgical s
Implant Applications
------------------------------------------------------------------------
Dental 24, Ortho ASTM F1537-00, Standard Transferred 30
137 Specification for Wrought from dental/
Cobalt-28-Chromium-6- ENT and
Molybdenum Alloy for orthopaedic
Surgical Implants (UNS s
R31537, UNS R31538, and
UNS R31539)
------------------------------------------------------------------------
Dental 25, Ortho ASTM F1580-95e1, Standard Transferred 31
139 Specification for from dental/
Titanium and Titanium-6% ENT and
Aluminum-4% Vanadium orthopaedic
Alloy Powders for s
Coatings of Surgical
Implants
------------------------------------------------------------------------
Dental 26, Ortho ASTM F1586-02, Standard Transferred 32
50 Specification for Wrought from dental/
Nitrogen Strengthened 21 ENT and
Chromium-Nickel-3 orthopaedic
Manganese-2.5 Molybdenum s
Stainless Steel Bar for
Surgical Implants (UNS
S31675)
------------------------------------------------------------------------
Dental 27, Ortho ASTM F1609-95, Standard Transferred 33
51 Specification for Calcium from dental/
Phosphate Coatings for ENT and
Implantable Materials orthopaedic
s
------------------------------------------------------------------------
Ortho 54 ASTM F1659-95, Standard Transferred 34
Test Method for Bending from
and Shear Testing of orthopaedic
Calcium Phosphate s
Coatings on Solid
Metallic Substrates
------------------------------------------------------------------------
Dental 28, Ortho ASTM F1713-96, Standard Transferred 35
56 Specification for Wrought from dental
Titanium-13 Niobium-13 /ENT and
Zirconium Alloy for orthopaedic
Surgical Implant s
Applications
------------------------------------------------------------------------
Ortho 116 ASTM F1801-97, Standard Transferred 36
Recommended Practice for from
Corrosion Fatigue Testing orthopaedic
of Metallic Implant s
Materials
------------------------------------------------------------------------
Rad 65 ASTM F2052-00, Standard Transferred 39
Test Method for from
Measurement of radiology
Magnetically Induced
Displacement Force on
Passive Implants in the
Magnetic Resonance
Environment
------------------------------------------------------------------------
[[Page 61902]]
G. Obstetrics and Gynecology (OB-GYN)/Gastroenterology
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
08 ISO 4047-1: 1996(E): Withdrawn and 26
Rubber Condoms--Part replaced with
1: Requirements newer version
------------------------------------------------------------------------
09 ISO 4074-2: 1994(E): Withdrawn and 26
Rubber Condoms--Part replaced with
2: Determination of newer version
Length
------------------------------------------------------------------------
10 ISO 4047-3: 1994(E): Withdrawn and 26
Rubber Condoms--Part replaced with
3: Determination of newer version
Width
------------------------------------------------------------------------
11 ISO 4047-5: 1996(E): Withdrawn and 26
Rubber Condoms--Part replaced with
5: Testing for newer version
Holes--Water Leak
Test
------------------------------------------------------------------------
12 ISO 4074-6: 1996(E): Withdrawn and 26
Rubber Condoms--Part replaced with
6: Determination of newer version
Bursting Volume and
Pressure
------------------------------------------------------------------------
13 ISO 4074-7: 1996(E): Withdrawn and 26
Rubber Condoms--Part replaced with
7: Oven Conditioning newer version
------------------------------------------------------------------------
14 ISO 4047-9: 1996(E): Withdrawn and 26
Rubber Condoms--Part replaced with
9: Determination of newer version
Tensile Properties
------------------------------------------------------------------------
H. Orthopaedics
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
27 ASTM F899-95, Withdrawn and .............
Standard transferred
Specification for to materials
Stainless Steel
Billet, Bar, and
Wire for Surgical
Instruments
------------------------------------------------------------------------
28 ASTM F961-96, Withdrawn and .............
Standard Transferred
Specification for to materials
Cobalt-35 Nickel-20
Chromium-10
Molybdenum Alloy
Forgings for
Surgical Implants
[UNS R30035]
------------------------------------------------------------------------
40 ASTM F1314-01, Withdrawn and .............
Standard Transferred
Specification for to materials
Wrought Nitrogen
Strengthened 22
Chromium-13 Nickel-5
Manganese-2.5
Molybdenum Stainless
Steel Alloy Bar and
Wire for Surgical
Implants (UNS
S20910)
------------------------------------------------------------------------
50 ASTM F1586-02, Withdrawn and .............
Standard Transferred
Specification for to materials
Wrought Nitrogen
Strengthened 21
Chromium-Nickel-3
Manganese-2.5
Molybdenum Stainless
Steel Bar for
Surgical Implants
(UNS S31675)
------------------------------------------------------------------------
51 ASTM F1609-95, Withdrawn and .............
Standard Transferred
Specification for to materials
Calcium Phosphate
Coatings for
Implantable
Materials
------------------------------------------------------------------------
54 ASTM F1659-95, Withdrawn and .............
Standard Test Method Transferred
for Bending and to materials
Shear Testing of
Calcium Phosphate
Coatings on Solid
Metallic Substrates
------------------------------------------------------------------------
56 ASTM F1713-96, Withdrawn and .............
Standard Transferred
Specification for to materials
Wrought Titanium-13
Niobium-13 Zirconium
Alloy for Surgical
Implant Applications
------------------------------------------------------------------------
86 ASTM F75-01, Standard Withdrawn and .............
Specification for transferred
Cobalt-28 Chromium-6 to Materials
Molybdenum Alloy
Castings and Casting
Alloy for Surgical
Implant (UNS R30075)
------------------------------------------------------------------------
[[Page 61903]]
87 ASTM F90-01, Standard Withdrawn and .............
Specification for Transferred
Wrought Cobalt-20 to materials
Chromium-15 Tungsten-
10 Nickel Alloy for
Surgical Implant
Applications (UNS
R30605)
------------------------------------------------------------------------
88 ASTM F136-98e1, Withdrawn and .............
Standard transferred
Specification for to Materials
Wrought Titanium-6
Aluminum-4 Vanadium
ELI (Extra Low
Interstitial) Alloy
(UNS R56401) for
Surgical Implant
Applications
------------------------------------------------------------------------
90 ASTM F560-98, Withdrawn and .............
Standard Transferred
Specification for to materials
Unalloyed Tantalum
for Surgical Implant
Applications (UNS
R05200, UNS R05400)
------------------------------------------------------------------------
97 ASTM F621-97, Withdrawn and .............
Standard Transferred
Specification for to materials
Stainless Steel
Forgings for
Surgical Implants
------------------------------------------------------------------------
109 ASTM F1185- Withdrawn and .............
88(1993)e1, Standard transferred
Specification for to Materials
Composition of
Ceramic
Hydroxylapatite for
Surgical Implants
------------------------------------------------------------------------
116 ASTM F1801-97, Withdrawn and .............
Standard Recommended transferred
Practice for to materials
Corrosion Fatigue
Testing of Metallic
Implant Materials
------------------------------------------------------------------------
123 ASTM F67-00, Standard Withdrawn and .............
Specification for transferred
Unalloyed Titanium to materials
for Surgical Implant
Applications (UNS
R50250, UNS R50550,
UNS R 50700)
------------------------------------------------------------------------
125 ASTM F139-00, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought 18 Chromium-
14 Nickel-2.5
Molybdenum Stainless
Steel Sheet and
Strip for Surgical
Implants (UNS
S31673)
------------------------------------------------------------------------
127 ASTM F562-00, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought Cobalt-35
Nickel-20 Chromium-
10 Molybdenum Alloy
for Surgical Implant
Applications
------------------------------------------------------------------------
128 ASTM F688-00, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought Cobalt-35
Nickel-2.5
Molybdenum Alloy
Plate, Sheet, and
Foil for Surgical
Implants (UNS
R30035)
------------------------------------------------------------------------
129 ASTM F745-00, Withdrawn and .............
Standard transferred
Specification for 18 to materials
Chromium-12.5 Nickel-
2.5 Molybdenum
Stainless Steel for
Cast and Solution-
Annealed Surgical
Implant Applications
------------------------------------------------------------------------
130 ASTM F799-99, Withdrawn and .............
Standard transferred
Specification for to Materials
Cobalt-28 Chromium-6
Molybdenum Alloy
Forgings for
Surgical Implants
(UNS R31537, R31538,
R31539)
------------------------------------------------------------------------
132 ASTM F1088-87 Withdrawn and .............
(1992)e1, Standard transferred
Specification for to materials
Beta-Tricalcium
Phosphate for
Surgical
Implantation
------------------------------------------------------------------------
133 ASTM F1108-97a, Withdrawn and .............
Standard transferred
Specification for to materials
Ti6A14V Alloy
Castings for
Surgical Implants
(UNS R56406)
------------------------------------------------------------------------
134 ASTM F1295-01, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought Titanium-6
Aluminum-7 Niobium
Alloy for Surgical
Implant Applications
(UNS R56700)
------------------------------------------------------------------------
135 ASTM F1341-99, Withdrawn and .............
Standard transferred
Specification for to materials
Unalloyed Titanium
Wire UNS R50250, UNS
R50400, UNS R50500,
UNS R50700, for
Surgical Implant
Applications
------------------------------------------------------------------------
[[Page 61904]]
136 ASTM F1472-00, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought Titanium-6
Aluminum-4 Vanadium
Alloy (UNS R56400)
for Surgical Implant
Applications
------------------------------------------------------------------------
137 ASTM F1537-00, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought Cobalt-28-
Chromium-6-
Molybdenum Alloy for
Surgical Implants
(UNS R31537, UNS
R31538, and UNS
R31539)
------------------------------------------------------------------------
138 ASTM F1541-01, Withdrawn and 158
Standard replaced with
Specification and newer version
Test Methods for
External Skeletal
Fixation Devices
------------------------------------------------------------------------
139 F1580-95e1, Standard Withdrawn and .............
Specification for transferred
Titanium and to materials
Titanium-6% Aluminum-
4% Vanadium Alloy
Powders for Coatings
of Surgical Implants
------------------------------------------------------------------------
144 ASTM F138-00, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought 18 Chromium-
14 Nickel-2.5
Molybdenum Stainless
Bar and Wire for
Surgical Implants
(UNS S31673)
------------------------------------------------------------------------
146 ASTM F603-00, Withdrawn and .............
Standard transferred
Specification for to materials
High-Purity Dense
Aluminum Oxide for
Surgical Implant
Application
------------------------------------------------------------------------
147 ASTM F620-00, Withdrawn and .............
Standard transferred
Specification for to materials
Alpha Beta Titanium
Alloy Forgings for
Surgical Implants
------------------------------------------------------------------------
148 ASTM F648-00, Withdrawn and .............
Standard transferred
Specification for to materials
Ultra-High-Molecular-
Weight Polyethylene
Powder and
Fabricated Form for
Surgical Implants
------------------------------------------------------------------------
149 ASTM F746-87 (1999), Withdrawn and .............
Standard Test Method transferred
for Pitting or to materials
Crevice Corrosion of
Metallic Surgical
Implant Materials
------------------------------------------------------------------------
151 ASTM F1091-91(2000), Withdrawn and .............
Standard transferred
Specification for to Materials
Wrought Cobalt-20
Chromium-15 Tungsten-
10 Nickel Alloy
Surgical Fixation
Wire (UNS R 30605)
------------------------------------------------------------------------
154 ASTM F1350-01, Withdrawn and .............
Standard transferred
Specification for to materials
Wrought 18 Chromium-
14 Nickel-2.5,
Molybdenum Stainless
Steel Surgical
Fixation Wire (UNS
S31673)
------------------------------------------------------------------------
I. Physical Medicine
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
21 ISO 7176-6:2001, Withdrawn and 29
Wheelchairs--Part 6: replaced with
Determination of newer version
Maximum Speed,
Acceleration and
Deceleration of
Electric Wheelchairs
------------------------------------------------------------------------
22 ISO 7176-9:2001, Withdrawn and 30
Wheelchairs--Part 9: replaced with
Climatic Tests for newer version
Electric Wheelchair
------------------------------------------------------------------------
J. Radiology
[[Page 61905]]
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
9 NEMA NU 1-2001, Withdrawn and 75
Performance replaced with
Measurements newer version
of
Scintillation
Cameras
------------------------------------------------------------------------
18 NEMA NU 2-2001, Withdrawn and 76
Performance replaced with
Measurement of newer version
Positron
Emission
Tomographs
------------------------------------------------------------------------
46 AIUM RTD1-- Title correction 46
1998, Standard
for Real-Time
Display of
Thermal and
Mechanical
Acoustic
Output Indices
on Diagnostic
Ultrasound
Equipment
Revision 1
------------------------------------------------------------------------
61 UL 122-2001, Title correction 61
Standard for
Safety of
Photographic
Equipment--Fou
rth Edition
------------------------------------------------------------------------
62 UL 187-1998, Title correction 62
Standard for
Safety X-ray
Equipment--Sev
enth Edition
------------------------------------------------------------------------
64 IEC 60601-2-45, Title correction 64
Ed. 2.0,
Medical
Electrical
Equipment:
Part 2-45:
Particular
Requirement
for the Safety
of
Mammographic X-
ray Equipment
and
Mammographic
Stereotactic
Devices
------------------------------------------------------------------------
66 MUS (R 1999), Title correction 66
Medical
Ultrasound
Safety
------------------------------------------------------------------------
67 NEMA MS-1-2001, Withdrawn and 77
Determination replaced with
of Signal to newer version
Noise Ratio
(SNR) in
Diagnostic
Magnetic
Resonance
Images
------------------------------------------------------------------------
70 NEMA PS 3.15 Withdrawn and 78
2000, Digital replaced with
Imaging and newer version
Communication
in Medicine
(DICOM) Part
15: Security
Profile
------------------------------------------------------------------------
73 UL-122 (R2001), Withdrawn ..............
Standard for
Safety,
Photographic
Equipment
------------------------------------------------------------------------
K. Sterility
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
01 AOAC 6.2.01:1995, Product codes 01
Official Method
955.24, Testing
Disinfectants
Against Salmonella
choleraesuis, Use-
Dilution Method
------------------------------------------------------------------------
02 AOAC 6.2.02:1995, Product codes 02
Official Method
991.47, Testing
Disinfectants
Against Salmonella
choleraesuis, Hard
Surface Carrier Test
Method
------------------------------------------------------------------------
03 AOAC 6.2.03:1995, Product codes 03
Official Method
991.48, Testing
Disinfectants
Against
Staphylococcus
aureus, Hard Surface
Carrier Test Method
------------------------------------------------------------------------
04 AOAC 6.2.04:1995, Product codes 04
Official Method
955.15, Testing
Disinfectants
Against
Staphylococcus
aureus, Use-Dilution
Method
------------------------------------------------------------------------
[[Page 61906]]
05 AOAC 6.2.05:1995, Product codes 05
Official Method and relevant
991.49, Testing guidance
Disinfectants
Against Pseudomonas
aeruginosa, Hard
Surface Carrier Test
Methods
------------------------------------------------------------------------
06 AOAC 6.2.06:1995, Product codes 06
Official Method and relevant
964.02, Testing guidance
Disinfectants
Against Pseudomonas
aeruginosa, Use-
Dilution Method
------------------------------------------------------------------------
07 AOAC 6.3.02:1995, Product codes 07
Official Method and relevant
955.17, Fungicidal guidance
Activity of
Disinfectants Using
Trichophyton
mentagrophytes
------------------------------------------------------------------------
08 AOAC 6.3.05:1995, Product codes 08
Official Method and relevant
966.04, Sporicidal guidance
Activity of
Disinfectants
------------------------------------------------------------------------
09 AOAC 6.3.06:1995, Product codes 09
Official Method and relevant
965.12, guidance
Tuberculocidal
Activity of
Disinfectants
------------------------------------------------------------------------
10 ANSI/AAMI ST8: 2001, Withdrawn and 71
Hospital Steam replaced with
Sterilization newer version
------------------------------------------------------------------------
11 ANSI/AAMI ST19:1994, Withdrawn .............
Biological
Indicators for
Saturated Steam
Sterilization
------------------------------------------------------------------------
12 ANSI/AAMI ST21:1994, Withdrawn .............
Biological
Indicators for
Ethylene Oxide
Sterilization
Processes in Health
Care Facilities
------------------------------------------------------------------------
14 AAMI/ANSI ST33:1992, Devices 72
Guidance for the affected
Selection and Use of
Reusable Rigid
Sterilization
Container Systems
for Ethylene Oxide
Sterilization and
Steam Sterilization
in Health Care
Facilities
------------------------------------------------------------------------
19 AAMI/ANSI ST46:1992, Devices 73
Good Hospital affected,
Practice Steam correction to
Sterilization and type of
Sterility Assurance standard, and
relevant
guidance
------------------------------------------------------------------------
22 ANSI/AAMI ST60:1996, Extent of 74
Sterilization of Recognition
Health Care and relevant
Products--Chemical guidance
Indicators--Part 1:
General Requirements
------------------------------------------------------------------------
25 AAMI/ANSI/ISO Relevant 25
11135:1994, Medical guidance
Devices--Validation
and Routine Control
of Ethylene Oxide
Sterilization
------------------------------------------------------------------------
26 AAMI/ANSI/ISO Withdrawn and 75
11137:1994, replaced with
Sterilization of newer
Health Care version,
Products--Requiremen relevant
ts for Validation guidance
and Routine Control-
Radiation
Sterilization and
ISO 11137:1995
(AMENDMENT 1:2001)
------------------------------------------------------------------------
37 AAMI/ANSI/ISO 10993- Withdrawn and 76
7:1995(R) 2001, replaced with
Biological newer
evaluation of version,
medical devices-- relevant
Part 7: Ethylene guidance
oxide sterilization
residuals
------------------------------------------------------------------------
38 ANSI/AAMI ST24:1999, Devices 77
Automatic General affected and
Purpose Ethylene type of
Oxide Sterilizers standard
and Ethylene Oxide
Sterilant Sources
Intended for Use in
Health Care
Facilities
------------------------------------------------------------------------
39 USP 25:2002, Withdrawn and 78
Biological Indicator replaced with
for Dry-Heat newer version
Sterilization Paper
Carrier
------------------------------------------------------------------------
40 USP 25:2002, Withdrawn and 79
Biological Indicator replaced with
for Ethylene Oxide newer version
Sterilization, Paper
Carrier
------------------------------------------------------------------------
41 USP 25:2002, Withdrawn and 80
Biological Indicator replaced with
for Steam newer version
Sterilization, Paper
Carrier
------------------------------------------------------------------------
42 USP 25:2002, <61 Microbial replaced with
Limits Test newer version
------------------------------------------------------------------------
[[Page 61907]]
43 USP 25:2002, Withdrawn and 82
Sterility Test replaced with
<71 newer version
------------------------------------------------------------------------
44 USP 25:2002, <85, Biological replaced with
Tests and Assays, newer version
Bacterial Endotoxin
Test (LAL)
------------------------------------------------------------------------
45 USP:2002 <151 Pyrogen Test replaced with
(USP Rabbit Test) newer version
------------------------------------------------------------------------
46 USP:2002 <1211 Sterilization replaced with
and Sterility newer version
Assurance of
Compendial Articles
------------------------------------------------------------------------
49 AAMI/ANSI ST41:1999, Citations, 49
Ethylene Oxide product codes
Sterilization in and relevant
Health Care guidance
Facilities: Safety
and Effectiveness
------------------------------------------------------------------------
52 ANSI/AAMI ST59:1999, Relevant 52
Sterilization of guidance
Health Care
Products--Biological
Indicators Part 1:
General Requirements
------------------------------------------------------------------------
53 AAMI/ANSI ST 66:1999, Relevant 53
Sterilization of guidance
Health Care
Products--Chemical
Indicators--Part 2:
Class 2 Indicators
for Air Removal Test
Sheets and Packs
------------------------------------------------------------------------
65 ASTM F1980:2002, Withdrawn and 86
Standard Guide for replaced with
Accelerated Aging of newer version
Sterile Medical
Device Packages
------------------------------------------------------------------------
66 USP 25:2002, <161 Transfusion replaced with
and Infusion newer version
Assemblies and
Similar Medical
Devices
------------------------------------------------------------------------
III. Listing of New Entries
FDA is adding new entries to the list of recognized standards as
follows:
A. Biocompatibility
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
65 Standard Practice for ASTM F2065-00
Testing for Alternative
Pathway Complement
Activation in Serum by
Solid Materials
------------------------------------------------------------------------
66 Standard Practice for ASTM F2148-01
Evaluation of Delayed
Contact Hypersensitivity
Using the Murine Local
Lymph Node Assay (LLNA)
------------------------------------------------------------------------
67 Standard Practice for ASTM F756-00
Assessment of Hemolytic
Properties of Materials
------------------------------------------------------------------------
B. Cardiovascular/Neurology
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
45 Testing and Reporting ANSI/AAMI EC57-98
Performance Results of
Cardiac Rhythm and ST-
Segment Measurement
Algorithms
------------------------------------------------------------------------
46 Standard Test Method for ASTM F2079-00
Measuring Recoil of
Balloon-Expandable Stents
------------------------------------------------------------------------
47 Standard Guide for ASTM F2081-02
Characterization and
Presentation of the
Dimensional Attributes of
Vascular Stents
------------------------------------------------------------------------
48 Test Method for Conducting ASTM F2129-01
Cyclic Potentiodynamic
Polarization Measurements
to Determine the
Corrosion Susceptibility
of Small Implant Devices
------------------------------------------------------------------------
C. Dental/Ear, Nose, and Throat (ENT)
[[Page 61908]]
------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
------------------------------------------------------------------------
92 Dental Brazing Alloys ANSI/ADA Specification
No. 88:2000
------------------------------------------------------------------------
93 Methods of Measurement ANSI C63.19:2001
of Compatibility
Between Wireless
Communication Devices
and Hearing Aids
------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
93 Sterlie Water for USP 25
Irrigation
------------------------------------------------------------------------
94 Heparin Lock Flush USP 25
Solution
------------------------------------------------------------------------
95 Sodium Chloride Injection USP 25
------------------------------------------------------------------------
96 Standard Test Method for ASTM F2101-01
Evaluating the Bacterial
Filtration Efficiency
(BFE) of Medical Face
Mask Materials, Using a
Biological Aerosol of
Staphylococcus aureus
------------------------------------------------------------------------
E. In Vitro Devices
------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
------------------------------------------------------------------------
62 Laboratory Automation: NCCLS: AUTO04-A
Systems Operational
Requirements,
Characteristics, and
Information Elements;
Approved Standard
------------------------------------------------------------------------
63 Laboratory Automation: NCCLS: AUTO05-A
Electromechanical
Interfaces; Approved
Standard
------------------------------------------------------------------------
64 Point-of-Care NCCLS: POCT1-A
Connectivity; Approved
Standard
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
------------------------------------------------------------------------
09 Standard Specification ASTM F563-00
for Wrought Cobalt-20
Nickel-20 Chromium-3.5
Molybdenum-3.5 Tungsten-
5 Iron Alloy for
Surgical Implant
Applications (UNS
R30563)
------------------------------------------------------------------------
37 Standard Specification ASTM F1813-01
for Wrought Titanium-12
Molybdenum-6 Zirconium-
2 Iron Alloy for
Surgical Implant (UNS
R58120)
------------------------------------------------------------------------
38 Standard Terminology for ASTM F2005-00
Nickel-Titanium Shape
Memory Alloys
------------------------------------------------------------------------
40 Standard Specification ASTM F2063-00
for Wrought Nickel-
Titanium Shape Memory
Alloys for Medical
Devices and Surgical
Implants
------------------------------------------------------------------------
41 Standard Specification ASTM F2066-01
for Wrought Titanium-15
Molybdenum Alloy for
Surgical Implant
Applications (UNS
R58150)
------------------------------------------------------------------------
42 Standard Test Method for ASTM F2119-01
Evaluation of MR Image
Artifacts from Passive
Implants
------------------------------------------------------------------------
43 Standard Specification ASTM F2146-01
for Wrought Titanium-3
Aluminum-2.5 Vanadium
Alloy Seamless Tubing
for Surgical Implant
Applications (UNS
R56320)
------------------------------------------------------------------------
[[Page 61909]]
G. OB-GYN/Gastroenterology
------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
------------------------------------------------------------------------
26 Natural Latex Rubber ISO 4074:2000(E)
Condoms--Requirements
and Test methods
------------------------------------------------------------------------
27 Standard Test Methods ASTM D6324-99a
for Male Condoms Made
from Synthetic
Materials
------------------------------------------------------------------------
H. Ophthalmic
------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
------------------------------------------------------------------------
30 Intraocular Lenses ANSI Z80.7:2001
------------------------------------------------------------------------
I. Radiology
------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
------------------------------------------------------------------------
79 High Voltage X-ray NEMA XR 7-1995 (R2000)
Cables and Receptacles
------------------------------------------------------------------------
80 Power Supply Guidelines NEMA XR 9-1984 (R1994,
for X-ray Machines R2000)
------------------------------------------------------------------------
81 Mechanical Safety NEMA XR 13-1990 (R1995,
Standard for Power R2000)
Driven Motions of
Electromedical
Equipment
------------------------------------------------------------------------
82 Recommended Practices NEMA XR 14-1990 (R1995,
for Load Bearing R2000)
Mechanical Assemblies
Used in Diagnostic
Imaging
------------------------------------------------------------------------
83 Medical Electrical IEC 60601-2-37 (2001-07)
Equipment, Part 2-37:
Particular Requirements
for the Safety of
Ultrasonic Medical
Diagnostic and
Monitoring Equipment
------------------------------------------------------------------------
84 Consol. Ed. 1.2 (incl. IEC 60825-1 (2001-08)
am1+am2), Safety of
Laser Products--Part 1:
Equipment
Classification,
Requirements and User's
Guide
------------------------------------------------------------------------
85 Ed. 2.0, Medical IEC 60601-2-22 (1995-11)
Electrical Equipment--
Part 2: Particular
Requirements for the
Safety of Diagnostic
and Therapeutic Laser
Equipment
------------------------------------------------------------------------
J. Sterility
------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
------------------------------------------------------------------------
88 Sterilization of Health ANSI/AAMI/ISO 14937:2000
Care Products--General
Requirements for
Characterization of a
Sterilizing Agent and
the Development,
Validation, and Routine
Control of a
Sterilization Process
for Medical Devices
------------------------------------------------------------------------
89 Standard Test Method for ASTM F2054-00
Burst Testing of
Flexible Package Seals
Using Internal Air
Pressurization Within
Restraining Plates
------------------------------------------------------------------------
90 Standard Test Methods ASTM F2095-01
for Pressure Decay Leak
Test for Nonporous
Flexible Packages With
and Without Restraining
Plates
------------------------------------------------------------------------
91 Standard Test Method for ASTM F2096-1
Detecting Gross Leaks
in Porous Medical
Packaging by Internal
Pressurization (Bubble
Test)
------------------------------------------------------------------------
92 Standard Guide for ASTM F2097-01
Design and Evaluation
of Primary Packaging
for Medical Products
------------------------------------------------------------------------
93 Biological Indicator for USP 25:2002
Steam Sterilization--
Self Contained
------------------------------------------------------------------------
[[Page 61910]]
IV. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the act by submitting such
recommendations, with reasons for the recommendation, to the contact
person (see FOR FURTHER INFORMATION CONTACT). To be properly
considered, such recommendations should contain, at a minimum, the
following information: (1) Title of the standard, (2) any reference
number and date, (3) name and address of the national or international
standards development organization, (4) a proposed list of devices for
which a declaration of conformity to this standard should routinely
apply, and (5) a brief identification of the testing or performance or
other characteristics of the device(s) that would be addressed by a
declaration of conformity.
V. Electronic Access
In order to receive ``Guidance on the Recognition and Use of
Consensus Standards'' via your fax machine, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt
press 1 to order a document. Enter the document number 321 followed by
the pound sign ([numsign]). Follow the remaining voice prompts to
complete your request.
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH home page includes
this guidance as well as the current list of recognized standards and
other standards related documents. After publication in the Federal
Register, this notice announcing ``Modifications to the List of
Recognized Standards, Recognition List Number: 007'' will be available
on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/cdrh. You may access ``Guidance on the Recognition and Use
of Consensus Standards,'' and the searchable data base for ``FDA
Recognized Consensus Standards,'' through hyperlinks at http://www.fda.gov/cdrh/stdsprog.html. This Federal Register notice of
modifications in FDA's recognition of consensus standards will be
available, upon publication, at http://www.fda.gov/cdrh/fedregin.html.
VI. Submission of Comments
You may, at any time, submit to the contact person (see FOR FURTHER
INFORMATION CONTACT) written comments regarding this document. You
should submit two copies of any comments, except that individuals may
submit one copy. You must identify comments with the docket number
found in brackets in the heading of this document. 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: 007.''
Dated: September 18, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-24954 Filed 10-1-02; 8:45 am]
BILLING CODE 4160-01-S