ASTM F749-98

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 749 – 98
Standard Practice for
Evaluating Material Extracts by Intracutaneous Injection in
the Rabbit
This standard is issued under the fixed designation F 749; 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 Refer to Sections 4.3 and 4.4 of Practice F 619 for a description
of this limitation.
1.1 This practice is a nonspecific, acute toxicity test used to
help determine the biocompatibility of materials used in
5. Apparatus
medical devices.
5.1 Cages—There shall be one cage for each rabbit exposed
1.2 The liquids injected in the rabbits are those obtained by
to one extract liquid. Each rabbit will be uniquely identified
Practice F 619 where the extraction vehicles are saline, veg-
with this identity recorded.
etable oil, or other liquids simulating human body fluids.
5.2 Syringes—Sterile syringes, not greater than 2 mL in
1.3 This practice is one of several developed for the
volume, with a precision of no less than6 0.10 mL shall be
assessment of the biocompatibility of materials. Practice F 748
used. Sterile needles of 21 to 26 gage shall be used.
may provide guidance for the selection of appropriate methods
for testing materials for a specific application.
6. Test Animals
2. Referenced Documents 6.1 Rabbits—The rabbits shall be thin-skinned albino type,
healthy, and not previously used for any test. Animal care shall
2.1 ASTM Standards:
2 be in accordance with Guide for Care and Use of Laboratory
F 619 Practice for Extraction of Medical Plastics
Animals. Rabbits with significant scars or wounds are not
F 748 Practice for Selecting Generic Biological Test Meth-
2 suitable for this test. For each extraction vehicle a minimum of
ods for Materials and Devices
two rabbits are used in the test. If the results of the first test are
3. Summary of Practice inconclusive, three more rabbits are needed to complete the test
with that extraction vehicle for one material.
3.1 The extract liquid is prepared in accordance with Prac-
6.1.1 During the test the rabbits shall be fed normally, with
tice F 619. The extraction vehicles are saline and vegetable oil,
commercially available feed and tap water.
or other extraction vehicles can be used, as described in
Practice F 619. The extract liquid is injected into rabbits and
7. Sampling
the animals are observed at regular intervals for 72 h for
7.1 Sample in accordance with Practice F 619.
erythema, edema, and necrosis.
8. Sample and Test Specimen
4. Significance and Use
8.1 The sample is the extract of the test article (that is,
4.1 This practice is to be used to help assess the biocom-
plastic or other material) exposed to the extraction procedure.
patibility of materials used in medical devices. It is an acute
As a result of the extraction in Practice F 619, for each
toxicological test designed to detect the presence of injurious
extraction vehicle there are available: (1) sample extract liquid,
leachable substances.
and (2) a blank extract liquid. These extract liquids are to be
4.2 This practice may not be appropriate for all types of
injected into the test animals within 24 h of the end of the
implant applications. The user is cautioned to consider the
extraction procedure. Record storage conditions if not used
appropriateness of the method in view of the materials being
immediately after preparation.
tested, their potential applications, and the recommendations
8.1.1 There are usually four extract liquids prepared from
contained in Practice F 748.
two extraction vehicles available for test, those based on saline
4.3 The only limitation applicable is the extract preparation.
and vegetable oil. Samples based on other extraction vehicles
may be available, as described in Practice F 619, or as required
by the standard for the medical device.
This practice is under the jurisdiction of ASTM Committee F-4 on Medical and
8.2 The test specimen is the combination of the test site and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
Current edition approved February 10, 1998. Published June 1998. Originally
e1 3
published as F 749 – 82. Last previous edition F 749 – 87 (1996) . U.S. Department of Health, Education, and Welfare, Guide for the Care and
Annual Book of ASTM Standards, Vol 13.01. Use of Laboratory Animals, Publication No. NIH 78-23, Bethesda, MD.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 749
TABLE 2 Severity Rating for Edema
0.2 mL of the injected extract liquid. A total of 10 sites are to
be injected with the sample extract liquid and 10 sites with the Numerical
A
Severity of Edema
Rating
blank extract liquid.
No edema 0
Very slight edema (barely perceptible) 1
9. Procedure
Slight edema (ed
...