Recognized Consensus Standards: Medical Devices
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Group Area |
Recognition
Number |
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Recognition |
Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
12/21/2020 | Anesthesiology | 1-148 | Complete | ISO | 80601-2-69 Second edition 2020-11 | Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment |
05/30/2022 | Anesthesiology | 1-152 | Complete | ISO | 80601-2-87 First edition 2021-04 | Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators |
12/19/2022 | Anesthesiology | 1-153 | Complete | NFPA | 99:2021 | Health Care Facilities Code |
12/19/2022 | Anesthesiology | 1-154 | Complete | ASME | PVHO-1-2019 | Safety Standard for Pressure Vessels for Human Occupancy |
12/19/2022 | Anesthesiology | 1-155 | Complete | ISO | 10079-2 Fourth edition 2022-03 | Medical suction equipment - Part 2: Manually powered suction equipment |
12/19/2022 | Anesthesiology | 1-156 | Complete | ISO | 10079-3 Fourth edition 2022-03 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
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 |
05/29/2023 | Anesthesiology | 1-161 | Complete | ISO | 16628 Second edition 2022-06 | Anaesthetic and respiratory equipment - Tracheobronchial tubes |
12/18/2023 | Anesthesiology | 1-162 | Complete | ISO | 10651-4 Second edition 2023-03 | Lung ventilators - Part 4: Particular requirements for user-powered resuscitators |