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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/26/2025 Radiology 12-378 Complete ISO 12609-1 Second edition 2021-10 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
12/23/2024 Anesthesiology 1-185 Complete ISO 80601-2-79 Second edition 2024-08 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
05/26/2025 Radiology 12-375 Complete ANSI UL 122-2019 Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019]
05/29/2024 Sterility 14-603 Complete AAMI TIR28:2016/(R)2020 Product adoption and process equivalence for ethylene oxide sterilization
12/23/2024 Sterility 14-608 Complete AAMI TIR106:2024 Microbiological methods - Understanding and use of product bioburden data
05/29/2023 Sterility 14-588 Complete AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
12/19/2022 Anesthesiology 1-160 Complete ISO 80601-2-84 First edition 2020-07 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
05/29/2024 Dental/
ENT		 4-325 Complete ANSI ADA Standard No. 96-2020 Dental Water-based Cements
12/18/2023 Dental/
ENT		 4-314 Complete ISO 7494-2 Third edition 2022-07 Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
12/18/2023 Dental/
ENT		 4-315 Complete ISO 24234 Third edition 2021-08 Dentistry - Dental Amalgam
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