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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2024 Ophthalmic 10-136 Complete IEC 80601-2-58 Edition 3.0 2024-03 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
ANSI AAMI IEC 80601-2-58:2024 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
12/23/2024 Dental/
ENT		 4-337 Complete ISO 20608 First edition 2018-04 Dentistry - Powder jet handpieces and powders
ANSI ADA Standard No. 212-2024 Dentistry - Powder Jet Handpieces and Powders
12/22/2025 Orthopedic 11-430 Complete ASTM F564-24 Standard Specification and Test Methods for Metallic Bone Staples
09/17/2018 Orthopedic 11-325 Complete ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
07/06/2020 Cardiovascular 3-165 Complete ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
01/30/2014 Dental/
ENT		 4-153 Complete ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
12/23/2024 Dental/
ENT		 4-338 Complete ISO 22683 First edition 2022-05 Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems
12/23/2024 General Plastic Surgery/
General Hospital		 6-503 Complete ISO 16571 Second edition 2024-03 Systems for evacuation of plume generated by medical device
12/18/2023 Cardiovascular 3-190 Complete ISO PAS 7020 First edition 2023-05 Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
01/14/2014 Radiology 12-268 Complete IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
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