ASTM F749-98(2007)e1
(Practice)Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
SIGNIFICANCE AND USE
This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.
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 F 748.
The only applicable limitation is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F 619 for a description of this limitation.
SCOPE
1.1 This practice is a nonspecific, acute toxicity test used to help determine the biocompatibility of materials used in medical devices.
1.2 The liquids injected into the rabbits are those obtained by Practice F 619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.4 The values stated in SI units are to be regarded as the standard.
General Information
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: F749 − 98(Reapproved 2007)
Standard Practice for
Evaluating Material Extracts by Intracutaneous Injection in
the Rabbit
ThisstandardisissuedunderthefixeddesignationF749;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.
´ NOTE—Formatting and grammar were corrected editorially throughout in April 2007.
1. Scope 4. Significance and Use
4.1 This practice is to be used to help assess the biocom-
1.1 This practice is a nonspecific, acute toxicity test used to
patibility of materials used in medical devices. It is an acute
help determine the biocompatibility of materials used in
toxicological test designed to detect the presence of injurious
medical devices.
leachable substances.
1.2 The liquids injected into the rabbits are those obtained
4.2 This practice may not be appropriate for all types of
by Practice F619 where the extraction vehicles are saline,
implant applications. The user is cautioned to consider the
vegetable oil, or other liquids simulating human body fluids.
appropriateness of the method in view of the materials being
1.3 This practice is one of several developed for the tested, their potential applications, and the recommendations
contained in Practice F748.
assessment of the biocompatibility of materials. Practice F748
may provide guidance for the selection of appropriate methods
4.3 The only applicable limitation is the extract preparation.
for testing materials for a specific application.
Refer to Sections 4.3 and 4.4 of Practice F619 for a description
of this limitation.
1.4 The values stated in SI units are to be regarded as the
standard.
5. Apparatus
5.1 Cages—There shall be one cage for each rabbit exposed
2. Referenced Documents
to one extract liquid. Each rabbit will be uniquely identified
2.1 ASTM Standards: with this identity recorded.
F619 Practice for Extraction of Medical Plastics
5.2 Syringes—Sterile syringes, not greater than 2 mL in
F748 PracticeforSelectingGenericBiologicalTestMethods
volume, with a precision of no less than 60.10 mL shall be
for Materials and Devices
used. Sterile needles of 21 to 26 gauge shall be used.
6. Test Animals
3. Summary of Practice
6.1 Rabbits—The rabbits shall be healthy thin-skinned al-
3.1 The extract liquid is prepared in accordance with Prac-
binotype,notpreviouslyusedforanytest.Animalcareshallbe
tice F619. The extraction vehicles are saline and vegetable oil,
in accordance with Guide for Care and Use of Laboratory
or other extraction vehicles can be used, as described in
Animals. Rabbits with significant scars or wounds are not
PracticeF619.Theextractliquidisinjectedintorabbitsandthe
suitableforthistest.Foreachextractionvehicle,aminimumof
animals are observed at regular intervals for 72 h for erythema,
two rabbits are used in the test. If the results of the first test are
edema, and necrosis.
inconclusive,threemorerabbitswillbeneededtocompletethe
test with that extraction vehicle for one material.
6.1.1 During the test the rabbits shall be fed normally, with
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
commercially available feed and tap water.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
7. Sampling
Current edition approved Feb. 1, 2007. Published February 2007. Originally
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approved in 1982. Last previous edition approved in 2002 as F749 – 98 (2002) .
7.1 Sample in accordance with Practice F619.
DOI: 10.1520/F0749-98R07E01.
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 The Guide for Care and Use of Laboratory Animals, Institute of Laboratory
Standards volume information, refer to the standard’s Document Summary page on Animal Research Publication. Available from National Academy Press, 500 Fifth
the ASTM website. St., NW, Lockbox 285, Washington, DC 20055.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F749 − 98 (2007)
TABLE 2 Severity Rating for Edema
8. Sample and Test Specimen
Numerical
A
8.1 The sample is the extract of the test article (that is, Severity of Edema
Rating
plastic or other material) exposed to the extraction procedure.
No edema 0
As a result of the extraction in Practice F619, for each
Very slight edema (barely perceptible) 1
Slight edema (edges of area defined by definite raising) 2
extraction vehicle there are available: (1) sample extract liquid,
Moderate edema (area raised approximately 1 mm) 3
and (2) a blank extract liquid. These extract liquids are to be
Severe edema (area raised more than 1 mm and 4
injected into the test animals within 24 h of the end of the
extending beyond area of injection)
A
extraction procedure. Record storage conditions if not used
Edemaistissueswelling.Apparentswellingattributabletotheinjectionvehicleis
immediately after preparation. not considered edema.
8.1.1 There are usually four extract liquids prepared from
two extraction vehicles available for test, those based on saline
10. Interpretation of Results
and vegetable oil. Samples based on other extract
...
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