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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/25/2026 Biocompatibility 2-314 Complete ISO 10993-12 Fifth edition 2021-01 [Including AMD1:2025] Biological evaluation of medical devices - Part 12: Sample preparation and reference materials [Including AMENDMENT 1 (2025)]
12/20/2021 Biocompatibility 2-295 Partial USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test)
08/21/2017 Biocompatibility 2-248 Complete ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
ANSI AAMI ISO 10993-4: 2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
12/22/2025 Biocompatibility 2-312 Complete ASTM F720-24 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
09/17/2018 Biocompatibility 2-256 Complete ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
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