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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/22/2025 Anesthesiology 1-199 Complete ISO 80601-2-70 Third edition 2025-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
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)]
12/22/2025 Biocompatibility 2-312 Complete ASTM F720-24 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
12/22/2025 Cardiovascular 3-201 Complete IEC 60601-2-31 Edition 3.0 2020-01 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
12/22/2025 Cardiovascular 3-202 Complete IEC 60601-2-34 Edition 4.0 2024-10 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
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