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U.S. Department of Health and Human Services

Recognized Consensus Standards

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05/20/2019 Software/
Informatics
13-35 ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
01/14/2019 Anesthesiology 1-114 ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
01/14/2019 Anesthesiology 1-117 ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
01/14/2019 Anesthesiology 1-120 ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
01/14/2019 Anesthesiology 1-138 ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
01/14/2019 Anesthesiology 1-141 ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
01/14/2019 Biocompatibility 2-136 ASTM E1262-88 (Reapproved 2018) Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
01/14/2019 Biocompatibility 2-141 ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
01/14/2019 Biocompatibility 2-145 ASTM F1439-03 (Reapproved 2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
01/14/2019 Biocompatibility 2-258 ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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