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U.S. Department of Health and Human Services

Recognized Consensus Standards
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12/19/2022 Anesthesiology 1-160 ISO 80601-2-84 First edition 2020-07 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
12/19/2022 Biocompatibility 2-289 ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/19/2022 Biocompatibility 2-296 ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
12/19/2022 General Plastic Surgery/
General Hospital		 6-483 IEC 60601-2-35 Edition 2.0 2020-09 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
12/19/2022 Radiology 12-347 IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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