ASTM F749-98(2002)e1

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.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.
e1
Designation: F 749 – 98 (Reapproved 2002)
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.
e NOTE—Footnote 3 was editorially corrected in November 2002.
1. Scope appropriateness of the method in view of the materials being
tested, their potential applications, and the recommendations
1.1 This practice is a nonspecific, acute toxicity test used to
contained in Practice F 748.
help determine the biocompatibility of materials used in
4.3 The only limitation applicable is the extract preparation.
medical devices.
Refer to Sections 4.3 and 4.4 of Practice F 619 for a description
1.2 The liquids injected in the rabbits are those obtained by
of this limitation.
Practice F 619 where the extraction vehicles are saline, veg-
etable oil, or other liquids simulating human body fluids.
5. Apparatus
1.3 This practice is one of several developed for the
5.1 Cages—There shall be one cage for each rabbit exposed
assessment of the biocompatibility of materials. Practice F 748
to one extract liquid. Each rabbit will be uniquely identified
may provide guidance for the selection of appropriate methods
with this identity recorded.
for testing materials for a specific application.
5.2 Syringes—Sterile syringes, not greater than 2 mL in
1.4 The values stated in SI units are to be regarded as the
volume, with a precision of no less than 60.10 mL shall be
standard.
used. Sterile needles of 21 to 26 gage shall be used.
2. Referenced Documents
6. Test Animals
2.1 ASTM Standards:
2 6.1 Rabbits—The rabbits shall be thin-skinned albino type,
F 619 Practice for Extraction of Medical Plastics
healthy, and not previously used for any test. Animal care shall
F 748 Practice for Selecting Generic Biological Test Meth-
2 be in accordance with Guide for Care and Use of Laboratory
ods for Materials and Devices
Animals. Rabbits with significant scars or wounds are not
3. Summary of Practice suitable for this test. For each extraction vehicle a minimum of
two rabbits are used in the test. If the results of the first test are
3.1 The extract liquid is prepared in accordance with Prac-
inconclusive, three more rabbits are needed to complete the test
tice F 619. The extraction vehicles are saline and vegetable oil,
with that extraction vehicle for one material.
or other extraction vehicles can be used, as described in
6.1.1 During the test the rabbits shall be fed normally, with
Practice F 619. The extract liquid is injected into rabbits and
commercially available feed and tap water.
the animals are observed at regular intervals for 72 h for
erythema, edema, and necrosis.
7. Sampling
4. Significance and Use 7.1 Sample in accordance with Practice F 619.
4.1 This practice is to be used to help assess the biocom-
8. Sample and Test Specimen
patibility of materials used in medical devices. It is an acute
8.1 The sample is the extract of the test article (that is,
toxicological test designed to detect the presence of injurious
plastic or other material) exposed to the extraction procedure.
leachable substances.
As a result of the extraction in Practice F 619, for each
4.2 This practice may not be appropriate for all types of
extraction vehicle there are available: (1) sample extract liquid,
implant applications. The user is cautioned to consider the
and (2) a blank extract liquid. These extract liquids are to be
injected into the test animals within 24 h of the end of the
extraction procedure. Record storage conditions if not used
This practice is under the jurisdiction of ASTM Committee F04 on Medical 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 The Guide for Care and Use of Laboratory Animals, Institute of Laboratory
e1
published as F 749 – 82. Last previous edition F 749 – 87 (1996) . Animal Research Publication. Available from National Academy Press, 500 Fifth
Annual Book of ASTM Standards, Vol 13.01. St., NW, Lockbox 285, Washington, DC 20055.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, 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.
e1
F 749 – 98 (2002)
TABLE 2 Severity Rating for Edema
immediately after preparation.
8.1.1 There are usually four extract liquids prepared from Numerical
A
Severity of Edema
Rating
two extraction vehicles available for test, those based on saline
No edema 0
and vegetable oil. Samples based on other extraction vehicles
Very slight edema (barely perceptible) 1
may be available, as described in Practice F 619, or as required
Slight edema (edges of area defined by definite raising) 2
by the standard for the medical device.
Moderate edema (area raised approximately 1 mm) 3
Severe edema (area raised more than 1 mm and 4
8.2 The test specimen is the combination of the test site and
extending beyond area of
...