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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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06/07/2018 General Plastic Surgery/
General Hospital		 6-402 Complete ASTM F1670/F1670M-17 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/29/2024 Radiology 12-354 Complete NEMA MS 4-2023 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
12/18/2023 Dental/
ENT		 4-309 Complete ISO 6877 Third edition 2021-09 Dentistry - Endodontic obturating materials
ANSI ADA Standard No. 78-2021 Dentistry - Endodontic Obturating Materials
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-128 Complete ISO CIE 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula
05/29/2024 Software/
Informatics		 13-139 Complete IEEE Std 11073-10206-2022 Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract Content Information Model
07/15/2019 Anesthesiology 1-126 Complete ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
05/29/2024 Anesthesiology 1-174 Complete ISO 18562-2 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
12/18/2023 Biocompatibility 2-302 Complete ASTM F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
04/04/2016 Sterility 14-333 Complete ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
05/29/2024 Materials 8-612 Complete ASTM F899-23 Standard Specification for Wrought Stainless Steels for Surgical Instruments
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