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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
12/22/2025 Dental/
ENT		 4-352 Complete ANSI ASA S3.35-2025 American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
12/22/2025 General Plastic Surgery/
General Hospital		 6-518 Complete ASTM F1670/F1670M-24a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/26/2025 Radiology 12-382 Complete NEMA NU 2-2024 Performance Measurements of Positron Emission Tomographs
07/28/2025 General II (ES/
EMC)		 19-57 Complete IEC 61326-2-6 Edition 4.0 2025-06 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
05/26/2025 Dental/
ENT		 4-339 Complete ANSI ADA Standard No. 119-2023 Dentistry-Manual Toothbrushes
06/07/2021 Anesthesiology 1-151 Complete ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
12/18/2023 ObGyn/
Gastroenterology/
Urology		 9-150 Complete ISO 7439 Fourth edition 2023-04 Copper-bearing contraceptive intrauterine devices - Requirements and tests
05/29/2024 General Plastic Surgery/
General Hospital		 6-502 Complete ISO 23217 First Edition 2024-02 Injection systems for self-administration by paediatric patients - Requirements and guidelines for design
12/23/2024 Anesthesiology 1-190 Complete ISO 9360-1 First edition 2000-03 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml
12/22/2025 Orthopedic 11-423 Complete ASTM F2267-24 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
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