ASTM F 2147 : 2001 : R2025
Current
The latest, up-to-date edition.
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
English
01-01-2025
| Committee |
F 04
|
| DocumentType |
Standard Practice
|
| Pages |
5
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
| Supersedes |
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
| ASTM F 748 : 2016 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ASTM F 619 : 2020 : R2025 | Standard Practice for Extraction of Materials Used in Medical Devices |
| ASTM F 619 : 2020 | Standard Practice for Extraction of Materials Used in Medical Devices |
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