ASTM F2147-01(2006) - 1.3.2006
 
1. Scope

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

1.2 This 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.

1.3 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

F619-20

Standard Practice for Extraction of Materials Used in Medical Devices

F720-17

Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

ISO 10993-10, 1995

Tests for Irritation and Sensitization Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.