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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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12/23/2019 Radiology 12-327 Complete ISO 11551 Third eidtion 2019-10 Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components
12/23/2019 General Plastic Surgery/
General Hospital
6-424 Complete ASTM D5151-19(2023) Standard Test Method for Detection of Holes in Medical Gloves
04/04/2016 Tissue Engineering 15-43 Complete ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
08/14/2015 Ophthalmic 10-94 Complete ISO 14730 Second edition 2014-10-01 Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
08/21/2017 Sterility 14-502 Complete ISO 11138-1 Third edition 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements
ANSI AAMI ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
06/07/2021 Radiology 12-337 Complete NEMA NU 1-2018 Performance Measurements of Gamma Cameras
07/09/2014 Dental/
ENT
4-160 Complete ANSI ASA S3.1-1999 (Reaffirmed 2023) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
12/23/2016 General I (QS/
RM)
5-113 Complete ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
01/27/2015 Dental/
ENT
4-218 Complete ISO 27020 First edition 2010-12-15 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2012 Orthodontic Brackets and Tubes
12/23/2016 Software/
Informatics
13-87 Complete ISO IEC 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
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