ASTM F749-98(2002)e2

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Designation:F749–98 (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.
e NOTE—Footnote 4 was editorially corrected in December 2002.
1. Scope 4.2 This practice may not be appropriate for all types of
implant applications. The user is cautioned to consider the
1.1 This practice is a nonspecific, acute toxicity test used to
appropriateness of the method in view of the materials being
help determine the biocompatibility of materials used in
tested, their potential applications, and the recommendations
medical devices.
contained in Practice F 748.
1.2 The liquids injected in the rabbits are those obtained by
4.3 The only limitation applicable is the extract preparation.
Practice F 619 where the extraction vehicles are saline, veg-
RefertoSections4.3and4.4ofPracticeF 619foradescription
etable oil, or other liquids simulating human body fluids.
of this limitation.
1.3 This practice is one of several developed for the
assessment of the biocompatibility of materials. Practice F 748
5. Apparatus
may provide guidance for the selection of appropriate methods
5.1 Cages—There shall be one cage for each rabbit exposed
for testing materials for a specific application.
to one extract liquid. Each rabbit will be uniquely identified
1.4 The values stated in SI units are to be regarded as the
with this identity recorded.
standard.
5.2 Syringes—Sterile syringes, not greater than 2 mL in
2. Referenced Documents volume, with a precision of no less than 60.10 mL shall be
used. Sterile needles of 21 to 26 gage shall be used.
2.1 ASTM Standards:
F 619 Practice for Extraction of Medical Plastics
6. Test Animals
F 748 Practice for Selecting Generic Biological Test Meth-
2 6.1 Rabbits—The rabbits shall be thin-skinned albino type,
ods for Materials and Devices
healthy, and not previously used for any test.Animal care shall
3. Summary of Practice be in accordance with Guide for Care and Use of Laboratory
Animals. Rabbits with significant scars or wounds are not
3.1 The extract liquid is prepared in accordance with Prac-
suitable for this test. For each extraction vehicle a minimum of
tice F 619.The extraction vehicles are saline and vegetable oil,
two rabbits are used in the test. If the results of the first test are
or other extraction vehicles can be used, as described in
inconclusive,threemorerabbitsareneededtocompletethetest
Practice F 619. The extract liquid is injected into rabbits and
with that extraction vehicle for one material.
the animals are observed at regular intervals for 72 h for
6.1.1 During the test the rabbits shall be fed normally, with
erythema, edema, and necrosis.
commercially available feed and tap water.
4. Significance and Use
7. Sampling
4.1 This practice is to be used to help assess the biocom-
7.1 Sample in accordance with Practice F 619.
patibility of materials used in medical devices. It is an acute
toxicological test designed to detect the presence of injurious
8. Sample and Test Specimen
leachable substances.
8.1 The sample is the extract of the test article (that is,
plastic or other material) exposed to the extraction procedure.
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
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
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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.
e2
F749–98 (2002)
TABLE 2 Severity Rating for Edema
As a result of the extraction in Practice F 619, for each
extraction vehicle there are available: (1) sample extract liquid, Numerical
A
Severity of Edema
Rating
and (2) a blank extract liquid. These extract liquids are to be
No edema 0
injected into the test animals within 24 h of the end of the
Very slight edema (barely perceptible) 1
extraction procedure. Record storage conditions if not used
Slight edema (edges of area defined by definite raising) 2
immediately after preparation.
Moderate edema (area raised approximately 1 mm) 3
Severe edema (area raised more than 1 mm and 4
8.1.1 There are usually four extract liquids prepared from
extending beyond area of injection)
two extraction vehicles available for test, those based on saline
A
Edemaistissueswelling.Apparentswellingattributabletotheinjectionvehicle
and vegetable oil. Samples based on other extraction vehicles
is not considered edema.
may be availab
...