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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/06/2020 Tissue Engineering 15-63 Complete ASTM F2739-19 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
01/14/2019 Ophthalmic 10-114 Complete ANSI Z80.28-2017 American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
07/09/2014 Materials 8-377 Complete ASTM F136-13 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
07/09/2014 Orthopedic 11-277 Complete ISO 7206-6 Second edition 2013-11-15 Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
07/09/2014 General I (QS/
RM)		 5-88 Complete ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
06/27/2016 Dental/
ENT		 4-228 Complete ANSI ASA S3.20-2015 (Reaffirmed 2020) American National Standard Bioacoustical Terminology
07/09/2014 Sterility 14-432 Complete ANSI AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities
06/27/2016 Dental/
ENT		 4-202 Complete ANSI ADA Standard No. 58-2010 (R2015) Root Canal Files, Type H (Hedstrom)
06/07/2018 Neurology 17-15 Complete ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
06/07/2018 Neurology 17-16 Complete IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
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