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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/22/2025 Biocompatibility 2-312 Complete ASTM F720-24 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
12/22/2025 Biocompatibility 2-311 Complete ISO 10993-4 Third edition 2017-04 [Including AMD1:2025] Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)]
12/19/2022 Biocompatibility 2-296 Partial ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
12/20/2021 Biocompatibility 2-295 Partial USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test)
06/07/2021 Biocompatibility 2-291 Partial ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
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