• ASTM F 2147 : 2001 : R2016

    Current The latest, up-to-date edition.

    Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-04-2016

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2016 Describes the potential for a substance, or material extract, to elicit contact dermal allergenicity.

    Scope - (Show below) - (Hide below)

    1.1This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.

    1.2This practice is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives associated with the latter test. See Rationale and References.

    1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.4This 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.

    General Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Standard Practice
    Product Note Reconfirmed 2016
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 748 : 2016 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
    ASTM F 720 : 2017 : REDLINE Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
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