ASTM-F719 › Historical Revision Information
Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
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Scope
1.1 This practice covers a procedure by which the irritancy of a biomaterial may be assessed through contact with abraded and intact skin of rabbits.
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Significance and Use
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and inexpensive method which, through use over the years, has become a generally accepted method.
Keywords
acute toxicity tests; biocompatibility; rabbits; skin irritation; test animals
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
11.100.99 (Other standards related to laboratory medicine)
11.220 (Veterinary medicine Including equipment specific to veterinary medicine)
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Document Number
ASTM-F719-81(2012)
Revision Level
1981 R12 EDITION
Status
Superseded
Modification Type
Reapproval
Publication Date
Oct. 15, 2012
Document Type
Practice
Page Count
3 pages
Committee Number
F04.16