ASTM F719 - 81(2012)

    Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

    Active Standard ASTM F719 | Developed by Subcommittee: F04.16

    Book of Standards Volume: 13.01

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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. 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.

    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    F619 Practice for Extraction of Medical Plastics

    ICS Code

    ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

    UNSPSC Code

    UNSPSC Code 73101701(Drugs or medicine production services)

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F0719-81R12

    Citation Format

    ASTM F719-81(2012), Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation, ASTM International, West Conshohocken, PA, 2012,

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