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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 General Plastic Surgery/
General Hospital		 6-519 Complete ASTM F2101-25 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
05/25/2026 Dental/
ENT		 4-394 Complete ISO 21672-1 First edition 2012-04 Dentistry - Periodontal probes - Part 1: General requirements
ANSI ADA Standard No. 169-2019 Periodontal Probes: General Requirements
05/25/2026 Dental/
ENT		 4-395 Complete ISO 21850-1 First edition 2020-04 Dentistry - Materials for dental instruments - Part 1: Stainless steel
ANSI ADA Standard No. 196-2021 Materials for Dental Instruments - Part 1: Stainless Steel
05/25/2026 Dental/
ENT		 4-396 Complete ISO 22570 First edition 2020-02 Dentistry - Spoons and bone curettes
05/29/2023 Radiology 12-350 Complete IEC 60806 Edition 2.0 2022-11 Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis
05/26/2025 Anesthesiology 1-196 Complete ISO 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
06/27/2015 Sterility 14-484 Complete ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
12/18/2023 Orthopedic 11-406 Complete ASTM F3141-23 Standard Guide for Total Knee Replacement Loading Profiles
05/26/2025 Cardiovascular 3-198 Complete ISO 25539-3 Second edition 2024-10 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
05/26/2025 Cardiovascular 3-200 Complete ASTM F2477-24 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
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