ASTM F763-04(2016)
(Practice)Standard Practice for Short-Term Screening of Implant Materials
Standard Practice for Short-Term Screening of Implant Materials
SIGNIFICANCE AND USE
5.1 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.
5.2 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.
5.3 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.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: F763 − 04 (Reapproved 2016)
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 F86 Practice for Surface Preparation and Marking of Metal-
lic Surgical Implants
1.1 This practice provides guidelines for short-term testing
F90 Specification for Wrought Cobalt-20Chromium-
or screening of candidate materials, both porous and dense, as
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
to the effects of the material on animal tissue in which it is
tions (UNS R30605)
implanted. This is a rapid screening procedure for determining
F136 Specification for Wrought Titanium-6Aluminum-
acceptability of candidate materials.
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
1.2 This practice, along with other appropriate biological
Implant Applications (UNS R56401)
tests (including other appropriateASTM tests) may be used in
F138 Specification for Wrought 18Chromium-14Nickel-
the biocompatibility assessment of the candidate materials for
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
use in the fabrication of devices for clinical application.
Implants (UNS S31673)
F562 Specification for Wrought 35Cobalt-35Nickel-
1.3 This experimental protocol is not designed to provide a
comprehensive assessment of the systemic toxicity, 20Chromium-10Molybdenum Alloy for Surgical Implant
Applications (UNS R30035)
carcinogenicity, teratogenicity, or mutagenicity of the material
since other standards deal with these issues. F563 Specification for Wrought Cobalt-20Nickel-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
1.4 This practice is one of several developed for the
for Surgical Implant Applications (UNS R30563) (With-
assessment of the biocompatibility of materials. Practice F748
drawn 2005)
provides guidance for the selection of appropriate methods for
F603 Specification for High-Purity Dense Aluminum Oxide
testing materials for a specific application.
for Medical Application
1.5 The values stated in SI units are to be regarded as
F648 Specification for Ultra-High-Molecular-Weight Poly-
standard. No other units of measurement are included in this
ethylene Powder and Fabricated Form for Surgical Im-
standard.
plants
1.6 This standard does not purport to address all of the F748 PracticeforSelectingGenericBiologicalTestMethods
safety concerns, if any, associated with its use. It is the for Materials and Devices
responsibility of the user of this standard to establish appro- F981 Practice for Assessment of Compatibility of Biomate-
priate safety and health practices and determine the applica- rials for Surgical Implants with Respect to Effect of
bility of regulatory limitations prior to use. Materials on Muscle and Bone
3. Terminology
2. Referenced Documents
3.1 Definitions of Terms Specific to This Standard:
2.1 ASTM Standards:
3.1.1 biocompatibility assay—a comparison of the tissue
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
response produced through the close association of the im-
Alloy Castings and Casting Alloy for Surgical Implants
planted candidate material to its implant site within the host
(UNS R30075)
animal to that tissue response recognized and established as
suitable with control materials.
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
4. Summary of Practice
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
4.1 Under aseptic conditions, test specimens of the candi-
Current edition approved April 1, 2016. Published June 2016. Originally
date material and of controls are inserted into a muscle or
approved in 1982. Last previous edition approved in 2010 as F763 – 04 (2010).
group of muscles of the animal host.After a period of time the
DOI: 10.1520/F0763-04R16.
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 (2016)
animals are euthanized. The tissue reactions to implants of the Negative Control Plastic or the alloys cited above, samples of
candidate material during the acute to subchronic time period these latter materials may be implanted as controls on the
of healing are compared with tissue reactions to control surgical technique.
materials which have a well characterized response. The
7. Test Specimens
implants are not subject to major stress while in situ.
7.1 Fabrication—Each implant shall be fabricated, finished,
5. Significance and Use
anditssurfacecleanedinamannerappropriateforitsprojected
application in humans. Dense metal implants should be fin-
5.1 The use of in vivo implantation techniques for charac-
ished in accordance with Practice F86. The size, shape, and
terizing the biocompatibility of materials to be utilized in
surface of test and control implants shall be as similar as is
various medical applications provides a unique assessment of
practically possible.
such materials not achieved by other procedures. Physical
characteristics (that is, form, density, hardness, surface finish)
7.2 Implantsizesarelefttothediscretionoftheinvestigator.
can influence the character of the tissue response to the test Implants in the size range 1 by 10 mm (0.04 by 0.4 in.) to 3.2
materials.
by 12 mm (0.125 by 0.5 in.) have often been used. They may
be of circular or square cross section. The edges of the
5.2 This practice is intended as a rapid screening procedure
specimens should be as smooth as possible to avoid additional
for determining the acceptability of candidate materials. It
mechanical trauma upon implantation.
would be invoked prior to using the long-term tests described
in Practice F981. It is understood that for some applications
7.3 Implantation Period:
additional tests, including long-term implantation studies, may 7.3.1 The insertion of all implants into any one animal shall
be required to assess the final suitability of the candidate
be done at the same surgical session.
materials.
7.3.2 Implant evaluation should be performed at 7 and 30 d
so that an accurate characterization of both the test and control
5.3 This practice may not be appropriate for all types of
materials can be made during the acute and subchronic stages
implant applications. The user is cautioned to consider the
of the healing tissue response. Three animals shall be used for
appropriateness of the method in view of the materials being
each sample period, that is, 3 at 7 d, and 3 at 30 d.
tested, their potential applications, and the recommendations
contained in Practice F748.
NOTE 2—Some investigators have found that extending the test to
include a third group of animals maintained for 90 d can provide
additional data on the host response to the implant material.
6. Test Preparation
6.1 Rabbits, rats, or other animals may be used as test hosts.
8. Procedure
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
6.2 Test Hosts and Sites:
samples, an incision of appropriate size will be required to
6.2.1 Choose healthy adult rabbits that weigh more than 2.5 permit passage of the larger diameter tube. If this technique is
kg and whose paravertebral muscles are sufficiently large to
not convenient, however, other equivalent implantation tech-
allow for implantation of the test specimens.
niques judged appropriate may be used. These should be
6.2.2 Theparavertebralmuscleshallserveasthetestsitefor
reported as in 9.1.The implantation shall be done using aseptic
implants. (The gluteal muscles of rats have been used as test procedures.
sites by some investigators.)
8.1.2 Preparation of Test Specimens—The specimens
6.2.3 Preparation of Rabbits—On the day of the implanta- should be fabricated as described in 7.1 and prepared for
tion or up to 20 h before implantation, clip the fur of the
implantation following the procedure in either 8.1.2.1 or
animals on both sides of the spinal column. Remove loose hair. 8.1.2.2.
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-
strated to elicit minimal tissue reactions, are the metal alloys,
NOTE 3—Allow for proper degassing if sterilizing agents such as
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
NOTE 1—There are times when use of a positive control can help to
clarify the character of the tissue response to the candidate test sample.
Turner, E., Lawrence, W. H., and Autian, J., “Subacute Toxicity Testing of
6.3.3 If the most appropriate control material is expected to
BiomaterialsUsingHistopathologicalEvaluationofRabbitMuscleTissue,” Journal
elicitatissueresponsegreaterthanthatnormallyobservedwith of Biomedical Materials Research, Vol 7, 1973, pp. 39–58.
F763 − 0
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F763 − 04 (Reapproved 2010) F763 − 04 (Reapproved 2016)
Standard Practice for
Short-Term Screening of Implant Materials
This standard is issued under the fixed designation F763; 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. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. 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.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2.1 ASTM Standards:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant
Applications (UNS R30563) (Withdrawn 2005)
F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved June 1, 2010April 1, 2016. Published November 2010June 2016. Originally approved in 1982. Last previous edition approved in 20042010 as
F763 – 04.F763 – 04 (2010). DOI: 10.1520/F0763-04R10.10.1520/F0763-04R16.
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 ASTM website.
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F763 − 04 (2016)
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 biocompatibility assay—a comparison of the tissue response produced through the close association of the implanted
candidate material to its implant site within the host animal to that tissue response recognized and established as suitable with
control materials.
4. Summary of Practice
4.1 Under aseptic conditions, test specimens of the candidate 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 candidate
material during the acute to subchronic time period of healing are compared with tissue reactions to control materials which have
a well characterized response. The implants are not subject to major stress while in situ.
5. Significance and Use
5.1 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.
5.2 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.
5.3 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.
6. Test Preparation
6.1 Rabbits, rats, or other animals may be used as test hosts. The following procedure is written for New Zealand white rabbits,
a commonly used test host but the procedure can be adapted with few alterations to other test hosts.
6.2 Test Hosts and Sites:
6.2.1 Choose healthy adult rabbits that weigh more than 2.5 kg and whose paravertebral muscles are sufficiently large to allow
for implantation of the test specimens.
6.2.2 The paravertebral muscle shall serve as the test site for implants. (The gluteal muscles of rats have been used as test sites
by some investigators.)
6.2.3 Preparation of Rabbits—On the day of the implantation or up to 20 h before implantation, clip the fur of the animals on
both sides of the spinal column. Remove loose hair.
6.3 Selection of Control Materials:
6.3.1 Selection of control material(s) should be based on their prior acceptable use in medical applications similar to those
proposed for the candidate test material and is not restricted to those listed in 6.3.2.
6.3.2 Metallic control materials, which have been demonstrated to elicit minimal tissue reactions, are the metal alloys, such as
in Specifications F75, F90, F136, F138, F562, or F563, or a ceramic, such as, alumina F603. A suitable polymeric control material
is found in polyethylene Specification F648.
NOTE 1—There are times when use of a positive control can help to clarify the character of the tissue response to the candidate test sample.
6.3.3 If the most appropriate control material is expected to elicit a tissue response greater than that normally observed with
Negative Control Plastic or the alloys cited above, samples of these latter materials may be implanted as controls on the surgical
technique.
7. Test Specimens
7.1 Fabrication—Each implant shall be fabricated, finished, and its surface cleaned in a manner appropriate for its projected
application in humans. Dense metal implants should be finished in accordance with Practice F86. The size, shape, and surface of
test and control implants shall be as similar as is practically possible.
7.2 Implant sizes are left to the discretion of the investigator. Implants in the size range 1 by 10 mm (0.04 by 0.4 in.) to 3.2
by 12 mm (0.125 by 0.5 in.) have often been used. They may be of circular or square cross section. The edges of the specimens
should be as smooth as possible to avoid additional mechanical trauma upon implantation.
7.3 Implantation Period:
7.3.1 The insertion of all implants into any one animal shall be done at the same surgical session.
7.3.2 Implant evaluation should be performed at 7 and 30 d so that an accurate characterization of both the test and control
materials can be made during the acute and subchronic stages of the healing tissue response. Three animals willshall be used for
each sample period, that is, 3 at 7 d, and 3 at 30 d.
F763 − 04 (2016)
NOTE 2—Some investigators have found that extending the test to include a third group of animals maintained for 90 d can provide additional data
on the host response to the implant material.
8. Procedure
8.1 Implantation:
8.1.1 The recommended method of implantation is by hypodermic needle or tube and trochar. For larger diameter samples, an
incision of appropriate size will be required to permit passage of the larger diameter tube. If this technique is not convenient,
however, other equivalent implantation techniques judged appropriate may be used. These should be reported as in 9.1. The
implantation mustshall be done using aseptic procedures.
8.1.2 Preparation of Test Specimens—The specimens should be fabricated as described in 7.1 and prepared for implantation
following the procedure in either 8.1.2.1 or 8.1.2.2.
8.1.2.1 Sterilize each specimen as appropriate for final application and, using aseptic technique, insert it into a sterile needle or
tube; or,
8.1.2.2 Insert the specimen into a needle or tube, protect the ends with an appropriate cover, and sterilize the assemblies in an
appropriate manner.
NOTE 3—Allow for proper degassing if sterilizing agents such as ethylene oxide are used.
NOTE 4—If the materials to be tested are harder than the materials from which the handling instruments are made, there is the danger of surface
contamination of the test specimens by wear from the instruments which can disturbaffect the results (for example, ceramic test specimens implanted with
metal instruments). If such tes
...
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