ASTM F763-04(2010)
(Practice)Standard Practice for Short-Term Screening of Implant Materials
Standard Practice for Short-Term Screening of Implant Materials
SIGNIFICANCE AND USE
The use of in vivo implantation techniques for characterizing the biocompatibility of materials to be utilized in various medical applications provides a unique assessment of such materials not achieved by other procedures. Physical characteristics (that is, form, density, hardness, surface finish) can influence the character of the tissue response to the test materials.
This practice is intended as a rapid screening procedure for determining the acceptability of candidate materials. It would be invoked prior to using the long-term tests described in Practice F981. It is understood that for some applications additional tests, including long-term implantation studies, may be required to assess the final suitability of the candidate materials.
This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
SCOPE
1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted. This is a rapid screening procedure for determining acceptability of candidate materials.
1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests) may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.
1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 provides guidance for the selection of appropriate methods for testing materials for a specific application.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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Standards Content (Sample)
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Designation: F763 − 04(Reapproved 2010)
Standard Practice for
Short-Term Screening of Implant Materials
ThisstandardisissuedunderthefixeddesignationF763;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
1.1 This practice provides guidelines for short-term testing
Implant Applications (UNS R56401)
or screening of candidate materials, both porous and dense, as
F138 Specification for Wrought 18Chromium-14Nickel-
to the effects of the material on animal tissue in which it is
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
implanted. This is a rapid screening procedure for determining
Implants (UNS S31673)
acceptability of candidate materials.
F562 Specification for Wrought 35Cobalt-35Nickel-
1.2 This practice, along with other appropriate biological
20Chromium-10Molybdenum Alloy for Surgical Implant
tests (including other appropriateASTM tests) may be used in
Applications (UNS R30035)
the biocompatibility assessment of the candidate materials for
F563 Specification for Wrought Cobalt-20Nickel-
use in the fabrication of devices for clinical application.
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
for Surgical Implant Applications (UNS R30563) (With-
1.3 This experimental protocol is not designed to provide a
comprehensive assessment of the systemic toxicity, drawn 2005)
F603 Specification for High-Purity Dense Aluminum Oxide
carcinogenicity, teratogenicity, or mutagenicity of the material
since other standards deal with these issues. for Medical Application
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.4 This practice is one of several developed for the
ethylene Powder and Fabricated Form for Surgical Im-
assessment of the biocompatibility of materials. Practice F748
plants
provides guidance for the selection of appropriate methods for
F748 PracticeforSelectingGenericBiologicalTestMethods
testing materials for a specific application.
for Materials and Devices
1.5 The values stated in SI units are to be regarded as
F981 Practice for Assessment of Compatibility of Biomate-
standard. No other units of measurement are included in this
rials for Surgical Implants with Respect to Effect of
standard.
Materials on Muscle and Bone
2. Referenced Documents 3. Terminology
2.1 ASTM Standards: 3.1 Definitions of Terms Specific to This Standard:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum 3.1.1 biocompatibility assay—a comparison of the tissue
Alloy Castings and Casting Alloy for Surgical Implants response produced through the close association of the im-
(UNS R30075) planted candidate material to its implant site within the host
F86 Practice for Surface Preparation and Marking of Metal- animal to that tissue response recognized and established as
lic Surgical Implants suitable with control materials.
F90 Specification for Wrought Cobalt-20Chromium-
4. Summary of Practice
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
tions (UNS R30605)
4.1 Under aseptic conditions, test specimens of the candi-
date material and of controls are inserted into a muscle or
group of muscles of the animal host.After a period of time the
animals are euthanized. The tissue reactions to implants of the
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
candidate material during the acute to subchronic time period
F04.16 on Biocompatibility Test Methods.
of healing are compared with tissue reactions to control
Current edition approved June 1, 2010. Published November 2010. Originally
materials which have a well characterized response. The
approved in 1982. Last previous edition approved in 2004 as F763 – 04. DOI:
implants are not subject to major stress while in situ.
10.1520/F0763-04R10.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F763 − 04 (2010)
5. Significance and Use application in humans. Dense metal implants should be fin-
ished in accordance with Practice F86. The size, shape, and
5.1 The use of in vivo implantation techniques for charac-
surface of test and control implants shall be as similar as is
terizing the biocompatibility of materials to be utilized in
practically possible.
various medical applications provides a unique assessment of
such materials not achieved by other procedures. Physical 7.2 Implantsizesarelefttothediscretionoftheinvestigator.
characteristics (that is, form, density, hardness, surface finish) Implants in the size range 1 by 10 mm (0.04 by 0.4 in.) to 3.2
can influence the character of the tissue response to the test by 12 mm (0.125 by 0.5 in.) have often been used. They may
materials. be of circular or square cross section. The edges of the
specimens should be as smooth as possible to avoid additional
5.2 This practice is intended as a rapid screening procedure
mechanical trauma upon implantation.
for determining the acceptability of candidate materials. It
would be invoked prior to using the long-term tests described 7.3 Implantation Period:
in Practice F981. It is understood that for some applications
7.3.1 The insertion of all implants into any one animal shall
additional tests, including long-term implantation studies, may be done at the same surgical session.
be required to assess the final suitability of the candidate 7.3.2 Implant evaluation should be performed at 7 and 30 d
materials. so that an accurate characterization of both the test and control
materials can be made during the acute and subchronic stages
5.3 This practice may not be appropriate for all types of
of the healing tissue response. Three animals will be used for
implant applications. The user is cautioned to consider the
each sample period, that is, 3 at 7 d, and 3 at 30 d.
appropriateness of the method in view of the materials being
tested, their potential applications, and the recommendations
NOTE 2—Some investigators have found that extending the test to
include a third group of animals maintained for 90 d can provide
contained in Practice F748.
additional data on the host response to the implant material.
6. Test Preparation
8. Procedure
6.1 Rabbits, rats, or other animals may be used as test hosts.
The following procedure is written for New Zealand white
8.1 Implantation:
rabbits, a commonly used test host but the procedure can be
8.1.1 The recommended method of implantation is by
adapted with few alterations to other test hosts.
hypodermic needle or tube and trochar. For larger diameter
samples, an incision of appropriate size will be required to
6.2 Test Hosts and Sites:
permit passage of the larger diameter tube. If this technique is
6.2.1 Choose healthy adult rabbits that weigh more than 2.5
not convenient, however, other equivalent implantation tech-
kg and whose paravertebral muscles are sufficiently large to
niques judged appropriate may be used. These should be
allow for implantation of the test specimens.
reported as in 9.1.The implantation must be done using aseptic
6.2.2 Theparavertebralmuscleshallserveasthetestsitefor
procedures.
implants. (The gluteal muscles of rats have been used as test
8.1.2 Preparation of Test Specimens—The specimens
sites by some investigators.)
should be fabricated as described in 7.1 and prepared for
6.2.3 Preparation of Rabbits—On the day of the implanta-
implantation following the procedure in either 8.1.2.1 or
tion or up to 20 h before implantation, clip the fur of the
8.1.2.2.
animals on both sides of the spinal column. Remove loose hair.
8.1.2.1 Sterilize each specimen as appropriate for final
6.3 Selection of Control Materials:
application and, using aseptic technique, insert it into a sterile
6.3.1 Selection of control material(s) should be based on
needle or tube; or,
their prior acceptable use in medical applications similar to
8.1.2.2 Insert the specimen into a needle or tube, protect the
those proposed for the candidate test material and is not
ends with an appropriate cover, and sterilize the assemblies in
restricted to those listed in 6.3.2.
an appropriate manner.
6.3.2 Metallic control materials, which have been demon-
NOTE 3—Allow for proper degassing if sterilizing agents such as
strated to elicit minimal tissue reactions, are the metal alloys,
ethylene oxide are used.
such as in Specifications F75, F90, F136, F138, F562,or F563,
NOTE 4—If the materials to be tested are harder than the materials from
or a ceramic, such as, alumina F603. A suitable polymeric
which the handling instruments are made, there is the danger of surface
control material is found in polyethylene Specification F648.
contamination of the test specimens by wear from the instruments which
can disturb the results (for example, ceramic test specimens implanted
NOTE 1—There are times when use of a positive control can help to
with metal instruments). If such test specimens must be handled, soft
clarify the character of the tissue response to the candidate test sample.
textile or plastic should be used between the implants and the instruments.
6.3.3 If the most appropriate control material is expected to
Of course, care must be taken that none of these auxiliary protecting
materials remain in the implantation wound.
elicitatissueresponsegreaterthanthatnormallyobservedwith
Negative Control Plastic or the alloys cited above, samples of
8.1.3 The animals should be anesthetized with a commonly
these latter materials may be implanted as controls on the
used anesthetic agent to a degree deep enough to prevent
surgical technique.
7. Test Specimens
Turner, E., Lawrence, W. H., and Autian, J., “Subacute Toxicity Testing
...
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