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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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12/21/2020 Orthopedic 11-330 Partial ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
09/21/2016 InVitro Diagnostics 7-265 Partial CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
05/30/2022 Sterility 14-572 Partial ANSI AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities
06/07/2021 Software/
Informatics		 13-117 Partial IEEE Std 11073-40101-2020 Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment.
08/14/2015 Software/
Informatics		 13-73 Partial IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
12/21/2020 Materials 8-543 Partial ASTM F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
06/07/2021 General Plastic Surgery/
General Hospital		 6-389 Partial IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
ANSI AAMI IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
06/07/2021 InVitro Diagnostics 7-236 Partial CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
04/04/2016 Tissue Engineering 15-44 Partial ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
06/07/2021 Cardiovascular 3-166 Partial ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
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