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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
01/14/2019 Orthopedic 11-347 Complete ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
04/04/2016 Tissue Engineering 15-24 Complete ASTM F2721-09 (Reapproved 2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
12/23/2019 Materials 8-521 Complete ASTM F2313-18 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
07/15/2019 Biocompatibility 2-263 Complete ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
12/21/2020 Dental/
ENT		 4-264 Complete ISO 9333 Second edition 2006-07 Dentistry - Brazing materials
ANSI ADA Standard No. 88-2019 Dental Brazing Alloys
06/07/2021 Orthopedic 11-379 Complete ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
07/06/2020 Sterility 14-540 Complete ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI AAMI ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
07/06/2020 Sterility 14-545 Complete ISO ASTM 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-121 Complete IEC 60601-2-16 Edition 5.0 2018-4 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
ANSI AAMI IEC 60601-2-16:2018 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
08/06/2013 Software/
Informatics		 13-38 Complete IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
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