ASTM F763-99(2003)
(Practice)Standard Practice for Short-Term Screening of Implant Materials
Standard Practice for Short-Term Screening of Implant Materials
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 prodedure 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 F 748 provides guidance for the selection of appropriate methods for testing materials for a specific application.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 763 – 99 (Reapproved 2003)
Standard Practice for
Short-Term Screening of Implant Materials
This standard is issued under the fixed designation F 763; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope Implants (UNS S31673)
F 562 Specification for Wrought Cobalt-35Nickel-
1.1 This practice provides guidelines for short-term testing
20Chromium–10Molybdenum Alloy for Surgical Implant
or screening of candidate materials, both porous and dense, as
Applications (UNS R30035)
to the effects of the material on animal tissue in which it is
F 563 Specification for Wrought Cobalt-20Nickel-
implanted. This is a rapid screening prodedure for determining
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
acceptability of candidate materials.
for Surgical Implant Applications (UNS R30563)
1.2 This practice, along with other appropriate biological
F 603 Specification for High-Purity Dense Aluminum Ox-
tests (including other appropriate ASTM tests) may be used in
ide for Surgical Implant Application
the biocompatibility assessment of the candidate materials for
F 648 Specification for Ultra-High-Molecular-Weight Poly-
use in the fabrication of devices for clinical application.
ethlene Powder and Fabricated Form for Surgical Implants
1.3 This experimental protocol is not designed to provide a
F 748 Practice for Selecting Generic Biological Test Meth-
comprehensive assessment of the systemic toxicity, carcinoge-
ods for Materials and Devices
nicity, teratogenicity, or mutagenicity of the material since
F 981 Practice for Assessment of Compatibility of Bioma-
other standards deal with these issues.
terials for Surgical Implants with Respect to Effect of
1.4 This practice is one of several developed for the
Materials on Muscle and Bone
assessment of the biocompatibility of materials. Practice F 748
provides guidance for the selection of appropriate methods for
3. Terminology
testing materials for a specific application.
3.1 Description of a Term Specific to this Standard:
2. Referenced Documents 3.1.1 biocompatibility assay—a comparison of the tissue
response produced through the close association of the im-
2.1 ASTM Standards:
planted candidate material to its implant site within the host
F 75 Specification for Cobalt-28Chromium-6Molybdenum
animal to that tissue response recognized and established as
Alloy Castings and Casting Alloy for Surgical Implants
suitable with control materials.
(UNS R30075)
F 86 Practice for Surface Preparation and Marking of Me-
4. Summary of Practice
tallic Surgical Implants
4.1 Under aseptic conditions, test specimens of the candi-
F 90 Specification for Wrought Cobalt-20Chromium-
date material and of controls are inserted into a muscle or
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
group of muscles of the animal host. After a period of time the
tions (UNS R30605)
animals are euthanized. The tissue reactions to implants of the
F 136 Specification for Wrought Titanium-6Aluminum-
candidate material during the acute to subchronic time period
4Vanadium 4V ELI (Extra Low Interstiitial) Alloy for
of healing are compared with tissue reactions to control
Surgical Implant Applications (UNS R56401)
materials which have a well characterized response. The
F 138 Specification for Wrought 18Chromium-14Nickel-
implants are not subject to major stress while in situ.
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
5. Significance and Use
This practice is under the jurisdiction of ASTM Committee F04 on Medical and 5.1 The use of in vivo implantation techniques for charac-
Surgical Materials and Devices and is the direct responsibility of Subcommittee
terizing the biocompatibility of materials to be utilized in
F04.16 on Biocompatibility Test Methods.
various medical applications provides a unique assessment of
Current edition approved Nov. 1, 2003. Published December 2003. Originally
such materials not achieved by other procedures. Physical
approved in 1982. Last previous edition approved in 1999 as F 763 – 99.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
characteristics (that is, form, density, hardness, surface finish)
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
can influence the character of the tissue response to the test
Standards volume information, refer to the standard’s Document Summary page on
materials.
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 763 – 99 (2003)
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 7.3 Implantation Period:
in Practice F 981. 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
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 will 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
NOTE 2—Some investigators have found that extending the test to
contained in Practice F 748.
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
8. Procedure
6.1 Rabbits, rats, or other animals may be used as test hosts.
8.1 Implantation:
The following procedure is written for New Zealand white
rabbits, a commonly used test host but the procedure can be 8.1.1 The recommended method of implantation is by
hypodermic needle or tube and trochar. For larger diameter
adapted with few alterations to other test hosts.
6.2 Test Hosts and Sites: samples, an incision of appropriate size will be required to
permit passage of the larger diameter tube. If this technique is
6.2.1 Choose healthy adult rabbits that weigh more than 2.5
kg and whose paravertebral muscles are sufficiently large to not convenient, however, other equivalent implantation tech-
niques judged appropriate may be used. These should be
allow for implantation of the test specimens.
6.2.2 The paravertebral muscle shall serve as the test site for reported as in 9.1. The implantation must be done using aseptic
procedures.
implants. (The gluteal muscles of rats have been used as test
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.
6.3 Selection of Control Materials: 8.1.2.1 Sterilize each specimen as appropriate for final
6.3.1 Selection of control material(s) should be based on application and, using aseptic technique, insert it into a sterile
their prior acceptable use in medical applications similar to needle or tube; or,
those proposed for the candidate test material and is not 8.1.2.2 Insert the specimen into a needle or tube, protect the
restricted to those listed in 6.3.2. ends with an appropriate cover, and sterilize the assemblies in
6.3.2 Metallic control materials, which have been demon- an appropriate manner.
strated to elicit minimal tissue reactions, are the metal alloys,
NOTE 3—Allow for proper degassing if sterilizing agents such as
such as in Specifications F 75, F 90, F 136, F 138, F 562, or
ethylene oxide are used.
F 563, or a ceramic, such as, alumina F 603. A suitable
NOTE 4—If the materials to be tested are harder than the materials from
polymeric control material is found in polyethylene Specifica- which the handling instruments are made, there is the danger of surface
contamination of the test specimens by wear from the instruments which
tion F 648.
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.
Of course, care must be taken that none of these auxiliary protecting
6.3.3 If the most appropriate control material is expected to
materials remain in the implantation wound.
elicit a tissue response greater than that normally observed with
8.1.3 The animals should be anesthetized with a commonly
Negative Control Plastic or the alloys cited above, samples of
these latter materials may be implanted as controls on the used anesthetic agent to a degree deep enough to prevent
muscular movement, such as twitching. Properly scrub the
surgical technique.
clipped skin surface of the animal.
7. Test Specimens
8.1.4 Implant four specimens of the sample into the paraver-
tebral muscle on one side of the spine of each rabbit, about 2.5
7.1 Fabrication—Each implant shall be fabricated, finished,
cm from the mid-line and
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.