ASTM F469-78

Practice for Assessment of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect of Materials on Tissue (Withdrawn 1987)

General Information

• Status: Withdrawn
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.02 - Division II - Orthopaedic Devices

Standards Content (Sample)

AMERICAN SOCIETV FOR TESTING AND MATERIALS
1916 Race St., Philadelphia, Pa. 19103
Reprinted from the Annual Book of ASTM Standards, Copyright ASTM
If not listed in the current combined index, will appear in the next edition.
Standard Practice for
ASSESSMENT OF COMPATIBILITY OF NONPOROUS
POLYMERlC MATERIALS FOR SURGICAL IMPLANTS
WITH REGARD TO EFFECT OF MATERIALS ON TISSUE'
This Standard is issued under the fued designation F 469; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year
of last reapproval.
1. scope and Wire for Surgical Implants (Special
Quality )3
1.1 This practice covers a series of experi-
F 361 Recommended Practice for Experi-
mental protocols for biological assays of tissue
mental Testing of Biological Compatibil-
reaction to nonporous (also nonfibrous) poly-
ity of Metals €or Surgical Implantss
meric materials for surgical implants with
2.2 Other Document:
regard to the effects of the material on animal
Guide for the Care and Use o€ Laboratory
tissue in which it is implanted. The experi-
Animals4
to provide a
mental protocol is not designed
comprehensive assessment of the systemic
3. Summary of Practice
toxicity, carcinogenicity, teratogenicity, or
3.1 This practice covers the preparation of
mutagenicity of the material. It applies only
implants, the number of implants and test
to materials with projected applications in
hosts, test sites, exposure schedule, and meth-
human subjects where the materials will re-
ods of implant retrieval and tissue examina-
side in skeletal or soft tissue for time periods
tion. A report shall be made of gross and
in excess of 30 days. Cardiovascular applica-
microscopical examination of each test site.
tions and applications in other organ systems
Histological criteria for evaluating tissue re-
or tissues for which these protocols may be
action are provided.
inappropriate are excluded. Control materials
will consist of any one of the metal alloys in
4. Significance
Specifications F 67. F 75, F 90, or F 138.
4.1 This is a test protocol for comparing
the local tissue response evoked by polymeric
materials, from which surgical devices might
ultimately be fabricated, with the locat tissue
67 Specification for Unalloyed Titanium
response elicited by control materials cur-
for Surgical Implant Applications-
rently accepted for the fabrication of surgical
75 Specification for Cast Cobalt-Chro-
devices. Currently accepted materials are
mium-Molybdenum Alloy for Surgical
Implant Applicationss
' This practice is under rhe jurisdiction of ASTM Com-
86 Recommended Practice for Surface mittee F-4 on Medical and Surgical Materials and Devices,
and is the direct responsibility of Subcommittee Fû4.20 on
Preparation and Marking of Metallic
Resources.
Surgical Implants3 Current edition approved June 30. 1978. Published
AuFust 1978.
90 Specification for Wrought Cobalt-
- Annual Book of ASTM Standards, Parts 8 and 46.
C h r o rn i u m- T u n gs te n - Nicke 1 A I lo y for Annual Book ofAST.M Standards, Part 46.
' Publication No. (NIH) 74-23, 1923. Available from
Surgical Implant Applications3
the Department of Health, Education and Welfare, Wash-
F 138Specifi&on foi Stainless Steel Bars ington, D.C.
I
0-1
,4217

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4CTb
metals (and metal alloys, see 2.1) that were
implants and one control implant in the mus-
standardized on the basis of acceptable long- cle on each side of the spine or in each femur.
term clinical experience. The metal controls 6.4.3 In each dog, there shall be four test
consistently produce cellular reaction and scar
implants and two control implants on each
to a degree that has been found to be accept- side of the spine or in each femur.
able to the host.
7. Conditioning
5. Test Hosts and Sites
7.1 Remove all surface contaminants and
5.1 Rats (strains in which the incidence of rinse all test and control implants in distilled
tumors is low), rabbits, and dogs are to be water prior to sterilization.
used as test hosts for soft tissue implants,
7.2 Package and sterilize all implants in
while rabbits and dogs are to be used as test the same way as is used for packaging and
hosts for bone implants. sterilizing similar materials for human implan-
5.2 Either the paravertebral muscle or fe- tation.
mur can serve as the test site for the implants. 7.3 After final preparation and steriliza-
However, the same site must be used for all tion, handle the test and control implants with
the implants in all the animal species. great care to ensure that they are not
5.3 Twenty rats, twelve rabbits, and six scratched, damaged, or contaminated in any
dogs will be used for studies utilizing intra- way prior to insertion.
7.4 Report all details of conditioning in
muscular implants, while twelve
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