[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Notices]
[Pages 9561-9569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4843]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0085]
FDA Modernization Act of 1997: Guidance for the Recognition and
Use of Consensus Standards; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is: (1) Announcing the
availability of a guidance entitled ``Guidance on the Recognition and
Use of Consensus Standards,'' the purpose of which is to provide
guidance to industry and reviewers within the Center for Devices and
Radiological Health (CDRH) on the use of recognized consensus
standards, including declarations of conformity to the standards,
during the evaluation of premarket submissions for medical devices; (2)
publishing the initial list of standards that will be recognized for
use in the premarket review process; and (3) announcing the agency's
policy on updating the list of recognized standards. This guidance will
assist manufacturers who elect to declare conformity with consensus
standards to meet all or part of medical device review requirements.
DATES: This guidance is effective on February 19, 1998; however,
written comments concerning this guidance may be submitted at any time.
ADDRESSES: Written comments concerning this guidance must be submitted
to the first contact person listed below. Comments should be identified
with the docket number found in brackets in the heading of this
document. Submit written requests for single copies of ``Recognition
and Use of Consensus Standards'' to the Division of Small Manufacturers
Assistance (DSMA), Center for Devices and Radiological Health (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 request, or fax your request to 301-443-8818. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
guidance. This guidance document may also be accessed via the Internet
at FDA's web site ``http://www.fda.gov/cdrh''.
FOR FURTHER INFORMATION CONTACT:
To comment on this guidance: Melvyn R. Altman, Associate Director
for Standards Policy, enter for Devices and Radiological Health (HFZ-
101),
[[Page 9562]]
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 301-594-4766, ext. 103.
To recommend additional standards for recognition:
James J. McCue, Director, Standards Program Coordination Staff,
enter for Devices and Radiological Health (HFZ-101), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
4766, ext. 137.
SUPPLEMENTARY INFORMATION:
I. Background
Many domestic and international consensus standards address
relevant aspects of safety and/or effectiveness of medical devices.
Many of these consensus standards have been developed with the
participation of FDA staff. Section 204 of the Food and Drug
Administration Modernization Act of 1997, Pub. L. 105-115, 111 Stat.
2296 (1997) (FDAMA) amends section 514 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360d), allowing the agency to
recognize consensus standards established by international and national
standards development organizations that may be used to satisfy
identified portions of device review requirements. This notice
announces the availability of a guidance document entitled ``Guidance
on the Recognition and Use of Consensus Standards,'' which describes
how FDA will implement that part of the FDAMA.
The agency has adopted Good Guidance Practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). Although ``Guidance on the Recognition and Use of Consensus
Standards'' is Level 1 guidance under the GGP's, this guidance will
become effective upon issuance. Under the GGP's the agency may elect
not to solicit public comment prior to implementation when there is a
new statutory requirement * * * that requires immediate implementation
and guidance is needed to help effect such implementation'' (62 FR 8961
at 8968). However, comments may be submitted at any time by interested
parties, and these comments will be considered in any future revisions
to the guidance.
This guidance document may contain collections of information that
require OMB clearance under the Paperwork Reduction Act of 1995. FDA
will seek such approval and provide an opportunity for comment, as
appropriate.
II. Use of Recognized Standards
A person required to submit a premarket application (i.e.,
Premarket Notification (510(k)), Investigational Device Exemptions
application (IDE), Premarket Approval application (PMA), Humanitarian
Device Exemption application (HDE), or Product Development Protocol
(PDP)) must provide information as required by the statute and
regulations to allow FDA to make an appropriate decision regarding the
clearance or approval of the submission. This guidance document
describes how FDA will recognize consensus standards and use
conformance with recognized standards to satisfy review requirements.
It does not affect FDA's ability to obtain any information authorized
by the statute or regulations. Use of consensus standards in this
manner is authorized by section 514 of the act, as amended by FDAMA.
FDA believes that conformance with applicable recognized consensus
standards can provide a reasonable assurance of safety and/or
effectiveness for many devices. Therefore, information submitted on
conformance with such standards will have a direct bearing on
determinations of safety and effectiveness made during the review of
IDE's, HDE's, PMA's, and PDP's. In case of 510(k)s, information on
conformance with recognized consensus standards may help establish the
substantial equivalence of a new device to a legally marketed predicate
device. This information can serve as a surrogate for comparative
information to show that the new device is as safe and effective as the
predicate in the areas covered by the standards. Moreover, if a
premarket submission contains a declaration of conformity to recognized
consensus standards, this will, in most cases, eliminate the need to
review actual test data for those aspects of the device addressed by
the standards. The content of a declaration of conformity is described
in the guidance document and is consistent with the ISO/IEC Guide 22.
Conformance with recognized consensus standards in and of itself,
however, may not always be a sufficient basis for regulatory decisions.
For example, a specific device may raise a safety or effectiveness
issue not addressed by any standard, or a specific FDA regulation may
require additional information beyond that which conformity to the
recognized consensus standards provides. Under such circumstances,
conformity with recognized standards will not satisfy all requirements
for marketing, or investigating, the product in the United States.
The guidance document, ``Guidance on the Recognition and Use of
Consensus Standards'', represents the agency's current thinking on the
use of recognized consensus standards for medical devices. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute,
regulations, or both.
III. List of Recognized Standards
The initial list of consensus standards to be recognized for use in
premarket review is presented at the end of this document. This list is
also maintained on the FDA web site ``http://www.fda.gov/cdrh''. Also
posted on the web site are supplemental data sheets for each recognized
standard. These data sheets list the address(es) where the standard can
be obtained, information on any limitations to the application of the
standard in medical device review, and a list of devices for which
declarations of conformity with the recognized standard will be
routinely accepted by agency reviewers. In addition to these documents,
the web site contains answers to frequently asked questions regarding
the use of recognized standards.
IV. Recommendation of Standards for Recognition by FDA
Modifications to the list of recognized consensus standards related
to medical devices will be announced in the Federal Register at least
once a year, or more often if necessary. FDA intends that the next
revision to the list of recognized standards will include standards to
be recognized by the Center for Biologics Evaluation and Research as
well as by CDRH.
Any person may recommend consensus standards as candidates for
recognition under new paragraph of section 514 of the act,
by submitting such recommendations, with justification, to the address
identified at the beginning of this document. 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 nationally or
internationally recognized standards development organization, (4) a
proposed list of devices for which a declaration of conformity should
routinely apply, and (5) a brief identification of the testing or
performance or other characteristics of
[[Page 9563]]
the device(s) that would be addressed by a declaration of conformity.
V. Electronic Access
In order to receive the guidance document ``Recognition and Use of
Consensus Standards,'' via your fax machine, call the CDRH Facts-On-
Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. At the first voice prompt press 1 to access DSMA Facts, at
the second voice prompt press 2, and then enter the document number
321, followed by the pound sign (#). Then follow the remaining voice
prompts to complete your request. Persons interested in obtaining a
copy of the guidance may also do so by using the World Wide Web (WWW).
CDRH maintains an entry on the WWW for easy access to information
including text, graphics, and files that may be downloaded to a
personal computer with access to the Web. Updated on a regular basis,
the CDRH Home Page includes the guidance Document ``Guidance on the
Recognition and Use of Consensus Standards'', as well as the list of
recognized standards and details on their application and information
on obtaining copies. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''.
A text-only version of the CDRH Web site is also available from a
computer or VT-100 compatible terminal by dialing 800-222-0185
(terminal settings are 8/1/N). Once the modem answers, press Enter
several times and then select menu choice 1: FDA Bulletin Board
Service. From there follow instructions for logging in, and at the BBS
TOPICS PAGE, arrow down to the FDA home page (do not select the first
CDRH entry). Then select Medical Devices and Radiological Health. From
there select Center for Devices and Radiological Health for general
information, or arrow down for specific topics.
VI. Comments
Interested persons may, at any time, submit to the contact person
listed above written comments regarding the guidance. Two copies of any
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Received comments will be
considered in determining whether to amend the current guidance.
----------------------------------------------------------------------------------------------------------------
Name of standards
Title of standard Reference number and date development organization
----------------------------------------------------------------------------------------------------------------
Generally Applicable Standards
----------------------------------------------------------------------------------------------------------------
1................. Biological Evaluation of ANSI/AAMI/ISO 10993-1 Association for the
Medical Devices--Part 1: Advancement of Medical
Guidance on Selection of Instrumentation.
Tests--First Edition.
2................. Medical Electrical IEC 60601-1 International
Equipment--Part 1: Electrotechnical
General Requirements for Commission (IEC).
Safety.\1\.
3................. Biological Evaluation of ISO 10993-1 International
Medical Devices--Part 1: Organization for
Guidance on Selection of Standardization (ISO).
Tests--First Edition
(Corrigendum 1-1992)(CEN
EN 30993-1:1994).
----------------------------------------------------------------------------------------------------------------
In Vitro Devices
----------------------------------------------------------------------------------------------------------------
1................. How to Define, Determine C28-A (1995) National Committee for
and Utilize Reference Clinical Laboratory
Intervals in the Standards (NCCLS).
Clinical Laboratory;
Approved Guideline.
2................. Method Comparison and EP9-A (1995) NCCLS.
Bias Estimation Using
Patient Samples;
Approved Guideline.
3................. Assessment of the GP-10-A (1995) NCCLS.
Clinical Accuracy of
Laboratory Tests Using
Receiver Operating
Characteristic (ROC)
Plots; Approved
Guideline.
4................. Labeling of Home-Use In GP14-A (1996) NCCLS.
Vitro Testing Products;
Approved Guideline.
5................. Procedures for the H18-A (1990) NCCLS.
Handling and Processing
of Blood Specimens;
Approved Guidelines.
6................. Specifications for ILA18-A (1994) NCCLS.
Immunological Testing
for Infectious Diseases;
Approved Guideline.
7................. Assessing the Quality of LAI-A2 (1994) NCCLS.
Radioimmunassay Systems--
Second Edition; Approved.
8................. Performance Standards for M2-A6 (1997) NCCLS.
Antimicrobial Disk
Susceptibility Tests--
Sixth Edition; Approved
Standard.
9................. Methods for Antimicrobial M11-A3 (1993) NCCLS.
Susceptibility Testing
of Anaerobic Bacteria--
Third Edition; Approved
Standard.
10................ Development of In Vitro M23A NCCLS.
Susceptibility Testing
Criteria and Quality
Control Parameters.
11................ Molecular Diagnostic MM3-(1995) NCCLS.
Methods for Infectious
Diseases; Approved
Guideline.
----------------------------------------------------------------------------------------------------------------
OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
1................. Hemodialysis Systems..... ANSI/AAMI RD5-1992 Association for the
Advancement of Medical
Instrumentation (AAMI).
2................. Standard Performance ASTM-D3492-96 American Society for
Specifications for Testing and Materials
Rubber Contraceptives (ASTM).
(Male Condom).
3................. Standard Performance ASTM F623-89 ASTM.
Specifications for Foley
Catheters.
----------------------------------------------------------------------------------------------------------------
[[Page 9564]]
Ophthalmic
----------------------------------------------------------------------------------------------------------------
1................. Optics and Optical ISO 9338:1996 International
Instruments--Contact Organization for
Lenses--Determination of Standardization (ISO).
the Diameters.
2................. Optics and Optical ISO 9339-1:1996 ISO.
Intruments--Contact
Lenses--Determination of
the Thickness--Part 1:
Rigid Contact Lenses.
3................. Optics and Optical ISO 9340:1996 ISO.
Intruments--Contact
Lenses--Determination of
Strains for Rigid
Contact Lenses.
4................. Optics and Optical ISO 9341:1996 ISO.
Intruments--Contact
Lenses--Determination of
Inclusions and Surface
Imperfections for Rigid
Contact Lens.
5................. Optics and Optical ISO 9363-1:1994 ISO.
Intruments--Contact
Lenses--Determination of
Cytotoxicity of Contact
Lens Material--Part 1:
Agar Overlay Test and
Growth Inhibition Test.
6................. Optics and Optical ISO 9394:1994 ISO.
Intruments--Contact
Lenses--Determination of
Biological Compatibility
of Contact Lens
Material--Testing of the
Contact Lens System by
Ocular Study with Rabbit
Eyes.
7................. Optics and Optical ISO 9913-1:1996 ISO.
Intruments--Contact
Lenses--Determination of
Oxygen Permeability and
Transmissibility with
the FATT Method.
8................. Optics and Optical ISO 10338:1996 ISO.
Intruments--Contact
Lenses--Determination of
Curvature.
9................. Optics and Optical ISO 10339:1997 ISO.
Intruments--Contact
Lenses--Determination of
Water Content of
Hydrogel Lenses.
10................ Optics and Optical ISO 10340:1995 ISO.
Intruments--Contact
Lenses--Method for
Determining the
Extractable Substances.
11................ Optics and Optical ISO 10344:1996 ISO.
Intruments--Contact
Lenses--Saline Solution
for Contact Lens Testing.
12................ Optics and Optical ISO 11980:1997 ISO.
Intruments--Contact
Lenses and Contact Lens
Care Products-- Guidance
for Clinical
Investigations.
----------------------------------------------------------------------------------------------------------------
Orthopaedics
----------------------------------------------------------------------------------------------------------------
1................. Standard Specifications ASTM F67-95 American Society for
for Unalloyed Titanium Testing and Materials
for Surgical Implant (ASTM)
Applications.
2................. Standard Specifications ASTM F75-92 ASTM.
for Cast Cobalt-Chromium-
Molybdenum Alloy for
Surgical Implant
Applications.
3................. Standard Practice for ASTM F86-91 ASTM.
Surface Preparation and
Marking of Metallic
Surgical Implants.
4................. Standard Specification ASTM F90-96 ASTM.
for Wrought Cobalt-20
Chromium-15 Tungsten-10
Nickel Alloy for
Surgical Implant
Aplications (UNS R30605).
5................. Standard Specification ASTM F136-96 ASTM.
for Wrought Titanium-6
Aluminum-4 Vanadium ELI
(Extra Low Interstitial)
Alloy (R56401) for
Surgical Implant
Applications.
6................. Standard Specification ASTM F138-92 ASTM.
for Stainless Steel Bar
and Wire for Surgical
Implants (Special
Quality).
7................. Standard Specification ASTM F-139-96 ASTM.
for Wrought-18 Chromium-
14 Nickel-2.5 Molybdenum
Stainless Sheet and
Strip for Surgical
Implants (UNS S31673).
8................. Standard Specification ASTM F366-82(r1993) ASTM.
for Fixation Pins and
Wires.
9................. Standard Specification ASTM F560-92 ASTM.
for Unalloyed Tantalum
for Surgical Implant
Applications.
10................ Standard Practice for ASTM F561-87 ASTM.
Analysis of Retrieved
Metallic Orthopaedic
Implants.
11................ Wrought Cobalt-35 Nickel- ASTM F562-95 ASTM.
20 Chromium-10
Molybdenum Alloy for
Surgical Implant
Applications.
12................ Standard Practice for ASTM F565 ASTM.
Care and Handling of
Orthopaedic Implants and
Instruments.
13................ Standard Practice for ASTM F601-86(1992) ASTM.
Fluorescent Penetrant
Inspection of Metallic
Surgical Implants.
[[Page 9565]]
14................ Standard Specification ASTM F603 ASTM.
for High-Purity Dense
Aluminum Oxide for
Surgical Implants.
15................ Standard Specification ASTM F604 ASTM.
Classifications for
Silicone Elastomers Used
in Medical Applications.
16................ Standard Specification ASTM F620 ASTM.
for Titanium 6A1-4V E11
Alloy Forgings for
Surgical.
17................ Standard Specification ASTM F621 ASTM.
for Stainless Steel
Forgings for Surgical
Implants.
18................ Standard Practice for ASTM F629-86 ASTM.
Radiography of Cast
Metallic Surgical
Implants.
19................ Standard Specification ASTM F648-84 ASTM.
for Ultra-High-Molecular-
Weight Polyethylene
Powder and Fabricated
Form for Surgical
Implants.
20................ Standard Specification ASTM F688-95 ASTM.
for Wrought Cobalt-35
Nickel-20 Chromium-10
Molybdenum Alloy Plate,
Sheet, and Foil for
Surgical Implants.
21................ Standard Specification ASTM F745-95 ASTM.
for 18 Chromium--12.5
Molybdenum Stainless
Steel for Cast and
Solution-Annealed
Surgical Implant
Applications.
22................ Standard Test Method for ASTM F746-87 ASTM.
Pitting or Crevice
Corrosion of Metallic
Surgical Implant
Materials.
23................ Standard Specification ASTM F786-82 ASTM.
for Metallic Bone Plates.
24................ Standard Specification ASTM F787-82 ASTM.
for Metallic Nail-Plate
Appliances.
25................ Standard Specification ASTM F799-96 ASTM.
for Cobalt-28 Chromium-6
Molybdenum Alloy
Forgings for Surgical
Implants (UNS R31537).
26................ Standard Test Method for ASTM F897-84 (r1993) ASTM.
Measuring Fretting
Corrosion of
Osteosynthesis Plates
and Screws.
27................ Standard Specification ASTM F899-95 ASTM.
for Stainless Steel
Billet, Bar, and Wire
for Surgical Instruments.
28................ Standard Specification ASTM F961-96 ASTM.
for Cobalt-Nickel-
Chromium-Molybdenum
Alloy Forgings for
Surgical Implant
Applications.
29................ Standard Practice for ASTM F983-86 ASTM.
Permanent Marking of
Orthopaedic Implant
Components.
30................ Standard Test Method for ASTM F1044-95 ASTM.
Shear Testing of Porous
Metal Coatings.
31................ Standard Specification ASTM F1088-87(R1992) ASTM.
for Beta-Tricalcium
Phosphate for Surgical
Implantation.
32................ Standard Test Method for ASTM F1089-87 ASTM.
Corrosion of Surgical
Instruments.
33................ Standard Specification ASTM F1091-91 (R1996) ASTM.
for Wrought Cobalt-20
Chromium-15 Tungsten-20
Nickel Alloy Surgical
Fixation Wire UNS R30605.
34................ Standard Specification ASTM F1108-97 ASTM.
for Titanium-6 Aluminum-
4 Vanadium Alloy
Castings for Surgical
Implants (UNS R56406).
35................ Standard Test Method for ASTM F1147-95 ASTM.
Tension Testing of
Porous Metal Coatings.
36................ Standard Test Method for ASTM F1160-91 ASTM.
Constant Stree Amplitude
Fatigue Testing of
Porous Metal-Coated
Metallic Materials.
37................ Standard Specification... ASTM F1185-88(1993) ASTM.
38................ Standard Guide for ASTM F1264-96a ASTM.
Mechanical Performance
Considerations for
Intrameduallary Fixation
Devices.
39................ Standard Specification ASTM F1295-97 ASTM.
for Wrought Titanium-6
Aluminum-7 Niobium Alloy
for Surgical Implant
Applications.
40................ Standard Specification ASTM F1314-95 ASTM.
for Wrought Nitrogen
Strengthened-22 Chromium-
12.5 Nickel-5 Manganese-
2.5 Molybdemum Stainless
Steel Bar and Wire for
Surgical Implants.
41................ Standard Specification ASTM F1341-92 ASTM.
for Unalloyed Titanium
Wire for Surgical
Implant Applications.
42................ Standard Specification ASTM F1350-96 ASTM.
for Wrought 18 Chromium-
14 Nickel-2.5 Molybdenum
Stainless Steel Surgical
Fixation Wire (UNS
S31673).
43................ Standard Specification ASTM F1377-92 ASTM.
for Cobalt-Chromium-
Molybdenum Powder for
Coating of Orthopaedic
Implants.
44................ Standard Specification ASTM F1472-93 ASTM.
for Wrought T1-6A1-4V
Alloy for Surgical
Implant Applications.
[[Page 9566]]
45................ Standard Test Methods for ASTM F1501-95 ASTM.
Tension Testing of
Calcium Phosphate
Coatings.
46................ Standard Specification ASTM F1537-94 ASTM.
For Wrought Cobalt-28-
Chromium-6-Molybdenum
Alloy for Surgical
Implants.
47................ Standard Classification ASTM F1541-94 ASTM.
of External Skeletal
Fixators.
48................ Standard Specification ASTM F1580-95 ASTM.
for Titanium and
Titanium-6% Aluminum-4%
Vanadium Alloy Powders
for Coatings of Surgical
Implants.
49................ Standard Terminology ASTM F1582-95 ASTM.
Relating to Spinal
Implants.
50................ Standard Specification ASTM F1586-95 ASTM.
for Wrought Nitrogen
Strengthened-21 Chromium-
10 Nickel-3 Manganese-
2.5 Molybdenum Stainless
Steel Bar for Surgical
Implants.
51................ Standard Specification ASTM F1609-95 ASTM.
for Calcium Phosphate
Coatings for Implantable
Materials.
52................ Standard Practice for ASTM F1612-95 ASTM.
Cydic Fatigue Testing of
Metallic Stemmed Hip
Arthroplasty Femoral
Components With Torsion.
53................ Standard Test Method for ASTM F1658-95 ASTM.
Shear Testing of Calcium
Phosphate Coatings.
54................ Standard Test Method for ASTM F1659-95 ASTM.
Bending and Shear
Fatigue Testing of
Calcium Phosphate
Coatings on Solid
Metallic Substrates.
55................ Standard Specification ASTM F1672-95 ASTM.
for Resurfacing Patellar
Prosthesis.
56................ Standard Specification ASTM F1713-96 ASTM.
for Wrought Titanium-13
Niobium-13 Zirconium
Alloy for Surgical
Implant Applications.
57................ Standard Test Methods for ASTM F1717-96 ASTM.
Static and Fatigue for
Spinal Implant
Constructs in a
Corpectomy Model.
58................ Standard Specification ASTM F1781-97 ASTM.
for Elastomeric Flexible
Hinge Finger Total Joint
Implants.
59................ Standard Test Methods for ASTM F1798 ASTM.
Evaluating the Static
and Fatigue Properties
of Interconnection
Mechanisms and
Subassemblies Used in
Spinal Arthrodesis.
60................ Cyclic Fatigue Testing of ASTM F1800 ASTM.
Metal Tibial Tray
Components of TKR.
61................ Standard Recommended ASTM F1801 ASTM.
Practice for Corrosion
Fatigue Testing of
Metallic Implant
Materials.
62................ Implants for Surgery-- ISO 5832-1 (1997) ISO.
Metallic Materials--Part
1: Wrought Stainless
Steel.
63................ Implants for Surgery-- ISO5832-2-93 ISO.
Metallic Materials--Part
2: Unalloyed Titanium.
64................ Implants for Surgery-- ISO 5832-3 (1996) ISO.
Metallic--Part 3:
Wrought Titanium 6-
Aluminum 4-Vanadium
Alloy Third Edition (CAN/
CSA-Z310.8-M91).
65................ Implants for Surgery-- ISO 5832-4-96 ISO.
Metallic Materials--Part
4: Cobalt-Chromium-
Molybdenum Casting Alloy.
66................ Implants for Surgery-- ISO 5832-5-93 ISO.
Metal Materials--Part 5:
Wrought Cobalt-Chromium-
Tungsten-Nickel Alloy.
67................ Implants for Surgery-- ISO 5832-6 ISO.
Metallic Materials--Part
6: Wrought Cobalt-Nickel-
Chromium-Molybdenum
Alloy.
68................ Implants for Surgery-- ISO 5832-9 (1992) ISO.
Metallic Materials--Part
9: Wrought High Nitrogen
Stainless Steel First
Edition.
69................ Implants for Surgery-- ISO 5832-10:1996 ISO.
Metallic Materials--Part
10: Wrought Titanium 5-
Aluminum 2.5-Iron.
70................ Implants for Surgery-- ISO 5832-11 (1994) ISO.
Metallic Materials--Part
11: Wrought Titanium 6-
Aluminum 7-Niobium Alloy
First Edition; CABN/CSA-
Z310.7:M91.
71................ Implants for Surgery-- ISO 5832-12-96 ISO.
Metalic Materials--Part
12: Wrought Cobalt-
Chromium-Molybdenum
Alloy.
72................ Implants for Surgery-- ISO 5834-2:1985 ISO.
Ultra-High Molecular
Weight Polyethylene--
Part 2: Moulded Forms.
73................ Implants for Surgery-- ISO 5838-1:1995 ISO.
Skeletal Pins and Wires--
Part 1: Material and
Mechanical Requirements.
[[Page 9567]]
74................ Implants for Surgery-- ISO 5838-2:1991 ISO.
Skeletal Pins and Wires--
Part 2: Steinmann
Skeletal Pins--
Dimensions.
75................ Implants for Surgery-- ISO 5838-3:1993 ISO.
Skeletal Pins and Wires--
Part 3: Kirschner
Skeletal Wires.
76................ Implants for Surgery-- ISO 6474-94 ISO.
Ceramic Materials Based
on High Purity Alumina.
77................ Surgical Instruments-- ISO 7153-1:1991 ISO.
Metallic Materials--Part
1: Stainless Steel.
78................ Implants for Surgery-- ISO 7206-4:1989 ISO.
Partial and Total Hip
Joint Prosthesis--Part
4: Determination of
Endurance Properties of
Stemmed Femoral
Components with
Application of Torsion.
79................ Implants for Surgery-- ISO 7206-8:1995 ISO.
Partial and Total Hip
Joint Prosthesis--Part
8: Endurance Performance
of Stemmed Femoral
Components with
Application of Torsion.
80................ Implants for Surgery-- ISO 8828 ISO.
Guidance on Care and
Handling of Orthopaedic
Implants.
81................ Implants for Surgery--Non ISO 9583:1993 ISO.
Destructive Testing--
Liguid Penetrant
Inspection of Metallic
Surgical Implants.
82................ Implants for Surgery--Non ISO 9584:1993 ISO.
Destructive Testing--
Radiological Examination
of Cast Metallic
Surgical Implants.
83................ Surgical and Dental Hand ISO 13402 ISO.
Instruments--Determinati
on of Resistance Against
Autoclaving, Corrosion
and Thermal Exposure.
84................ Implants for Surgery-- ISO 13782: 1996 ISO.
Metallic Materials--
Unalloyed Tantalum for
Surgical Implant
Applications.
85................ Non-Active Surgical ISO 14630:1997 ISO
Implants--General
Requirements.
----------------------------------------------------------------------------------------------------------------
Physical Medicine
----------------------------------------------------------------------------------------------------------------
1................. Determination of Static ANSI/RESNA WC/01-1990 Rehabilitation
Stability. Engineering and
Assistive Technology
Society of North
American (RESNA).
2................. Determination of Dynamic ANSI/RESNA WC/02-1991 RESNA.
Stability of Electric
Wheelchairs.
3................. Determination of the ANSI/RESNA WC/03-1990 RESNA.
Effectiveness of Brakes.
4................. Determination of Energy ANSI/RESNA WC/04-1990 RESNA.
Consumption of Electric
Wheelchairs.
5................. Determination of Overall ANSI/RESNA WC/05-1990 RESNA.
Dimensions, Mass and
Turning Space--
Wheelchair.
6................. Determination of Maximum ANSI/RESNA WC/06-1991 RESNA.
Speed, Acceleration, and
Retardation of Electric
Wheelchairs.
7................. Wheelchairs--Determinatio ANSI/RESNA WC/07-1991 RESNA.
n of Seating and Wheel
Dimensions.
8................. Wheelchairs--Static, ANSI/RESNA WC/08-1991 RESNA.
Impact and Fatigue
Strength Tests.
9................. Climatic Tests for ANSI/RESNA WC/09-1991 RESNA.
Electric Wheelchairs.
10................ Determination of the ANSI/RESNA WC/10-1990 RESNA.
Obstacle-Climbing
Ability of Electric
Wheelchairs.
11................ Wheelchairs--Test Dummies ANSI/RESNA WC/11-1991 RESNA.
12................ Coefficient of Friction ANSI/RESNA WC/13-1991 RESNA.
of Test Surfaces.
13................ Wheelchairs--Testing of ANSI/RESNA WC/14-1991 RESNA.
Power and Control
Systems for Electric
Wheelchairs.
14................ Wheelchairs--Requirements ANSI/RESNA WC/15-1991 RESNA.
for Information
Disclosure,
Documentation and
Labelling.
15................ Wheelchairs--Determinatio ANSI/RESNA WC/16-1991 RESNA.
n of Flammability.
16................ Wheelchairs--Part 1: ISO 7176-1:1986 ISO.
Determination of Static
Stability.
17................ Wheelchairs--Part 2: ISO 7176-2:1990 ISO.
Determination of Dynamic
Stability of Electric
Wheelchairs.
18................ Wheelchairs--Part 3: ISO 7176-3:1988 ISO.
Determination of
Efficiency of Brakes.
19................ Wheelchairs--Part 4: ISO 7176-4:1997 ISO.
Energy Consumption of
Electric Wheelchairs and
Scooters for
Determination of
Theoretical Distance
Range.
20................ Wheelchairs--Part 5: ISO 7176-5:1986 ISO.
Determination of Overall
Dimensions, Mass and
Turning Space.
[[Page 9568]]
21................ Wheelchairs--Part 6: ISO 7176-6:1988 ISO.
Determination of Maximum
Speed, Acceleration and
Retardation of Electric
Wheelchairs.
22................ Wheelchairs--Part 9: ISO 7176-9:1988 ISO.
Climatic Tests for
Electric Wheelchairs.
23................ Wheelchairs--Part 10: ISO 7176-10:1988 ISO.
Determination of
Obstacle-Climbing
Ability of Electric
Wheelchairs.
24................ Wheelchairs--Part 11: ISO 7176-11:1992 ISO.
Test Dummies.
25................ Wheelchairs--Part 13: ISO 7176-13:1989 ISO.
Determination of
Coefficient of Friction
of Test Surfaces.
26................ Wheelchairs--Part 14: ISO 7176-14:1997 ISO.
Power and Control
Systems for Electric
Wheelchairs--Requirement
s and Test Methods.
27................ Wheelchairs--Part 15: ISO 7176-15:1996 ISO.
Requirements for
Information Disclosure,
Documentation and
Labeling.
28................ Wheelchairs--Part 16: ISO 7176-16:1997 ISO.
Resistance to Ignition
of Upholstered Parts--
Requirements and Test
Methods.
----------------------------------------------------------------------------------------------------------------
Radiology
----------------------------------------------------------------------------------------------------------------
1................. Medical X-Ray Screen-Film- ANSI PH2.43-1982 American National
Processing Systems, Standards Institute
Method for the (ANSI).
Sensitometry.
2................. Photography (films)-- ANSI/NAPM IT1.49-1995 National Association of
Medical Hard Copy Photographic
Imaging Films-- Manufacturers, (NAPM).
Dimensions and
Specifications.
3................. Photography (Films)-- ANSI/NAPM IT1.49-1995 NAPM.
Medical Radiographic
Cassettes/Screens/Films--
Dimensions.
4................. Medical Ultrasound Safety AIUM-1994 American Institute of
Ultrasound in Medicine
(AIUM).
5................. Photography-Direct-- ANSI/NAPM IT2.48-1993 NAPM.
Exposing Medical and
Dental Radiographic Film/
Process Systems--
Determination of ISO
Speed and ISO Average
Gradient.
6................. Determination of the IEC 806(R1984) IEC.
Maximum Symmetrical
Radiation Field from a
Rotating Anode X-Ray
Tube for Medical
Diagnosis.
7................. Information Technology- ISO/IEC 10918-1:1994 ISO or IEC.
Digital Compression and
Coding of Continuous-
Tone Still Images:
Requirements and
Guidelines.
8................. X-Ray Tube Assemblies for IEC60336(R1993) IEC.
Medical Diagnosis
Characteristics of Focal
Spots.
9................. Performance Measurements NEMA NU1-1994 NEMA.
of Scintillation Cameras.
10................ Determination of Signal NEMA MS1-1988(R1994) NEMA.
to Noise Ratio (SNR) in
Magnetic Resonance
Images.
11................ Determination of Two- NEMA MS2-1989 NEMA.
Dimensional Geometric
Distortion in Diagnostic
Magnetic Resonance
Images.
12................ Determination of Image NEMA MS3-1989 NEMA.
Uniformity in Diagnostic
Magnetic Resonance
Images.
13................ Acoustic Noise NEMA MS4-1989 NEMA.
Measurement Procedure
for Diagnostic Magnetic
Resonance Imaging
Devices.
14................ Determination of Slice NEMA MS5-1991 NEMA.
Thickness in Diagnostic
Magnetic Resonance
Imaging.
15................ Characterization of NEMA MS6-1991 NEMA.
Special Purpose Coils
for Diagnostic Magnetic
Resonance Images.
16................ Measurement Procedure for NEMA MS7-1993 NEMA.
Time-Varying Gradiant
Fields (dB/dt) for
Magnetic Resonance
Imaging Systems.
17................ Characterization of the NEMA MS8-1993 NEMA.
Specific Absoption Rate
for Magnetic Resonance
Imaging Systems.
18................ Performance Measurements NEMA NU2-1994 NEMA.
of Positron Emission
Tomographs.
19................ DICOM set--Digital NEMA PS3 (Set) NEMA.
Imaging and
Communications in
Medicine--Set Includes
PS3.1 through PS3.13.
20................ Acoustic Output NEMA UD2-1992 NEMA.
Measurement Standard for
Diagnostic Ultrasound
Equipment.
21................ Standard for Real-Time NEMA UD3-1992 NEMA.
Display of Thermal and
Mechanical Acoustic
Output.
22................ Measurement of Dimensions NEMA XR5-1992 NEMA.
and Properties of Focal
Spots of Diagnostic X-
Ray Tubes.
[[Page 9569]]
23................ Measurement of the NEMA XR10-1986 (R1992) NEMA.
Maximum Symmetrical
Radiation Field from a
Rotating Anode X-Ray
Tube Used for Medical
Diagnosis.
24................ Test Standard for NEM XR11-1993 NEMA.
Determination of the
Limiting Spatial
Resolution of X-Ray
Image Intensifier
Systems.
25................ Test Standard for the NEMA XR15-1991 NEMA.
Determination of the
Visible Entrance Field
Size of an X-Ray Image
Intensifier System.
26................ Test Standard for the NEMA XR16-1991 NEMA.
Determination of the
System Contrast Ratio
and the System Veiling
Glare Index of an X-Ray
Image Intensifier System.
27................ Test Standard for the NEMA XR17-1993 NEMA.
Measurement for the
Image Signal Uniformity
of an X-Ray Image
Intensifier System.
28................ Test Standard for the NEMA XR18-1993 NEMA.
Determination of the
Radial Image Distortion
of an X-Ray Image
Intensifier System.
29................ Electrical Thermal and NEMA XR19-1993 NEMA.
Loading Characteristics
of X-Ray Tubes Used for
Medical Diagnosis.
30................ Standard for Safety: UL-122 Underwriters Laboratory
Photographic Equipment. (UL).
31................ Standard for Safety: X- UL-187 UL.
Ray Equipment.
32................ Standard for Safety: UL-544 UL.
Medical and Dental
Equipment--Third Edition.
----------------------------------------------------------------------------------------------------------------
\1\ The recognition of this standard for all devices was proposed for comment January 13, 1998 (63 FR 1974), and
is not yet final. This listing applies only to radiological imaging devices.
Dated: February 13, 1998.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-4843 Filed 2-20-98; 3:59 pm]
BILLING CODE 4160-01-P
