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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2024 Anesthesiology 1-177 Complete ISO 80601-2-74 Second edition 2021-07 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
05/29/2024 Anesthesiology 1-178 Complete ISO 23747 Second edition 2015-08 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
05/29/2024 Anesthesiology 1-179 Partial ISO 26782 First edition 2009-07 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)]
05/29/2024 Cardiovascular 3-191 Complete ISO 18242 First edition 2016-09-01 [Including AMD1:2023] Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps [Including AMENDMENT 1 (2023)]
05/29/2024 Cardiovascular 3-192 Complete ISO 22679 First edition 2021-11 Cardiovascular implants - Transcatheter cardiac occluders
05/29/2024 Dental/
ENT		 4-325 Complete ANSI ADA Standard No. 96-2020 Dental Water-based Cements
05/29/2024 Dental/
ENT		 4-326 Complete ISO 9687 Second edition 2015-02 Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)]
05/29/2024 Dental/
ENT		 4-327 Complete ISO 21531 First edition 2009-02 Dentistry - Graphical symbols for dental instruments
05/29/2024 General II (ES/
EMC)		 19-50 Partial IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
05/29/2024 General Plastic Surgery/
General Hospital		 6-498 Complete ISO 10555-4 Third edition 2023-11 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
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