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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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F619 Practice for Extraction of Medical Plastics
ICS Number Code 11.220 (Veterinary medicine)
UNSPSC Code 73101701(Drugs or medicine production services)
ASTM F719-81(2012), Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation, ASTM International, West Conshohocken, PA, 2012, www.astm.orgBack to Top