ASTM F749-13
(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
4.1 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.
4.2 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 F748.
4.3 The only applicable limitation is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 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 F619 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 F748 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 standard. No other units of measurement are included in this standard.
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Designation: F749 − 13
Standard Practice for
Evaluating Material Extracts by Intracutaneous Injection in
1
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.
1. Scope 4. Significance and Use
1.1 This practice is a nonspecific, acute toxicity test used to 4.1 This practice is to be used to help assess the biocom-
help determine the biocompatibility of materials used in patibility of materials used in medical devices. It is an acute
medical devices. toxicological test designed to detect the presence of injurious
leachable substances.
1.2 The liquids injected into the rabbits are those obtained
by Practice F619 where the extraction vehicles are saline, 4.2 This practice may not be appropriate for all types of
vegetable oil, or other liquids simulating human body fluids. implant applications. The user is cautioned to consider the
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
assessment of the biocompatibility of materials. Practice F748
contained in Practice F748.
may provide guidance for the selection of appropriate methods
for testing materials for a specific application. 4.3 The only applicable limitation is the extract preparation.
Refer to Sections 4.3 and 4.4 of Practice F619 for a description
1.4 The values stated in SI units are to be regarded as
of this limitation.
standard. No other units of measurement are included in this
standard.
5. Apparatus
2. Referenced Documents
5.1 Cages—There shall be one cage for each rabbit exposed
2
to one extract liquid. Each rabbit shall be uniquely identified
2.1 ASTM Standards:
with this identity recorded.
F619 Practice for Extraction of Medical Plastics
F748 PracticeforSelectingGenericBiologicalTestMethods
5.2 Syringes—Sterile syringes, not greater than 2 mL in
for Materials and Devices
volume, with a precision of no less than 60.10 mL shall be
used. Sterile needles of 21 to 26 gauge shall be used.
3. Summary of Practice
6. Test Animals
3.1 The extract liquid is prepared in accordance with Prac-
tice F619. The extraction vehicles are saline and vegetable oil,
6.1 Rabbits—The rabbits shall be healthy thin-skinned al-
or other extraction vehicles can be used, as described in
binotype,notpreviouslyusedforanytest.Animalcareshallbe
PracticeF619.Theextractliquidisinjectedintorabbitsandthe
in accordance with Guide for Care and Use of Laboratory
3
animals are observed at regular intervals for 72 h for erythema,
Animals. Rabbits with significant scars or wounds are not
edema, or necrosis.
suitableforthistest.Foreachextractionvehicle,aminimumof
three rabbits are used in the test. If the results of the first test
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland are inconclusive, three more rabbits will be needed to complete
Surgical Materials and Devices and is the direct responsibility of Subcommittee
the test with that extraction vehicle for one material.
F04.16 on Biocompatibility Test Methods.
6.1.1 During the test the rabbits shall be fed normally, with
Current edition approved March 1, 2013. Published March 2013. Originally
commercially available feed and tap water.
approved in 1982. Last previous edition approved in 2012 as F749 – 98 (2012).
DOI: 10.1520/F0749-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3
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 − 13
TABLE 1 Severity Rating for Erythema
7. Sampling
Numerical
7.1 Sample in accordance with Practice F619. Severity of Erythema
Rating
No erythema 0
8. Sample and Test Specimen
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
8.1 The sample is the extract of the test article (that is,
Moderate to severe 3
plastic or other material) exposed to the extraction procedure.
Severe erythema (beet redness) to slight eschar formation 4
(injuries in depth)
As a result of the extraction in Practice F619, for each
extraction vehicle there are available: (1) sample extract liquid,
and (2) a blank extr
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F749 − 98 (Reapproved 2012) F749 − 13
Standard Practice for
Evaluating Material Extracts by Intracutaneous Injection in
1
the Rabbit
This standard is issued under the fixed designation F749; 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 (´) indicates an editorial change since the last revision or reapproval.
1. 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 F619 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 F748 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 standard. No other units of measurement are included in this standard.
2. Referenced Documents
2
2.1 ASTM Standards:
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
3. Summary of Practice
3.1 The extract liquid is prepared in accordance with Practice F619. The extraction vehicles are saline and vegetable oil, or other
extraction vehicles can be used, as described in Practice F619. The extract liquid is injected into rabbits and the animals are
observed at regular intervals for 72 h for erythema, edema, or necrosis.
4. Significance and Use
4.1 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.
4.2 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 F748.
4.3 The only applicable limitation is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description
of this limitation.
5. Apparatus
5.1 Cages—There shall be one cage for each rabbit exposed to one extract liquid. Each rabbit shall be uniquely identified with
this identity recorded.
5.2 Syringes—Sterile syringes, not greater than 2 mL in volume, with a precision of no less than 60.10 mL shall be used. Sterile
needles of 21 to 26 gauge shall be used.
1
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 Oct. 1, 2012March 1, 2013. Published October 2012March 2013. Originally approved in 1982. Last previous edition approved in 20072012 as
ε1
F749 – 98 (2007)(2012). . DOI: 10.1520/F0749-98R12.10.1520/F0749-13.
2
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F749 − 13
6. Test Animals
6.1 Rabbits—The rabbits shall be healthy thin-skinned albino type, not previously used for any test. Animal care shall be in
3
accordance with Guide for Care and Use of Laboratory Animals. Rabbits with significant scars or wounds are not suitable for this
test. For each extraction vehicle, a minimum of twothree rabbits are used in the test. If the results of the first test are inconclusive,
three more rabbits will be needed to complete the test with that extraction vehicle for one material.
6.1.1 During the test the rabbits shall be fed normally, with commercially available feed and tap water.
7. Sampling
7.1 Sample in accordance with Practice F619.
8. Sample and Test Specimen
8.1 The sample is the extract of the test article (that is, plastic or other material) exposed to the extraction procedure. As a result
of the extraction in Practice F619, for each extraction vehicle there are available: (1) sample extract liquid, and (2) a blank extract
liquid. These ex
...
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