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U.S. Department of Health and Human Services

Recognized Consensus Standards

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07/22/2019 Software/
Informatics
13-35 ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
07/15/2019 Anesthesiology 1-116 ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems
07/15/2019 Anesthesiology 1-122 ISO 5364 Fifth edition 2016-09-01 Anaesthetic and respiratory equipment-Oropharyngeal airways
07/15/2019 Anesthesiology 1-125 ISO 8836 Fourth edition 2014-10-15 Suction catheters for use in the respiratory tract
07/15/2019 Anesthesiology 1-126 ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
07/15/2019 Anesthesiology 1-142 ISO 10079-1 Third Edition 2015-11-01 Medical suction equipment - Part 1: Electrically powered suction equipment [Including: Amendment 1 (2018)]
07/15/2019 Anesthesiology 1-143 ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
07/15/2019 Anesthesiology 1-144 ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
07/15/2019 Biocompatibility 2-263 ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
07/15/2019 Biocompatibility 2-264 ASTM F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
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