Recognized Consensus Standards: Medical Devices
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Date of
Entry |
Specialty Task
Group Area |
Recognition
Number |
Extent of
Recognition |
Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
07/15/2019 | Anesthesiology | 1-122 | Complete | ISO | 5364 Fifth edition 2016-09-01 | Anaesthetic and respiratory equipment-Oropharyngeal airways |
03/16/2012 | Anesthesiology | 1-73 | Complete | ISO | 10651-4 First edition 2002-03-01 | Lung ventilators - Part 4: Particular requirements for operator powered resuscitators |
03/16/2012 | Anesthesiology | 1-62 | Complete | ISO | 5356-1 Third edition 2004-05-15 | Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets |
ANSI AAMI ISO | 5356-1:2004 | Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets | ||||
06/07/2018 | Anesthesiology | 1-136 | Complete | ISO | 18562-3 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds |
05/29/2023 | Anesthesiology | 1-161 | Complete | ISO | 16628 Second edition 2022-06 | Anaesthetic and respiratory equipment - Tracheobronchial tubes |
05/29/2024 | Anesthesiology | 1-176 | Complete | ISO | 18562-4 Second Edition 2024-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate |
05/29/2024 | Anesthesiology | 1-172 | Complete | ISO | 11712 Second edition 2023-11 | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
07/15/2019 | Anesthesiology | 1-126 | Complete | ISO | 11712 First edition 2009-05-15 | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
12/19/2022 | Anesthesiology | 1-157 | Complete | ISO | 10079-1 Fourth edition 2022-03 | Medical suction equipment - Part 1: Electrically powered suction equipment |
12/19/2022 | Anesthesiology | 1-158 | Complete | ISO | 10079-4 First edition 2021-08 | Medical suction equipment - Part 4: General requirements |