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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)
 
05/29/2023 Dental/
ENT		 4-305 Partial ISO 10637 Second edition 2018-05 Dentistry - Central suction source equipment
ANSI ADA Standard No. 177-2020 Central Suction Source Equipment
05/29/2023 Dental/
ENT		 4-306 Partial ISO 22052 First edition 2020-06 Dentistry - Compressed air source equipment
ANSI ADA Standard No. 94-2021 Central Compressed Air Source Equipment
05/29/2023 Dental/
ENT		 4-307 Complete ISO 13504 First edition 2012-07 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
05/29/2023 Dental/
ENT		 4-308 Complete ISO 14708-7 Second edition 2019-12 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
05/29/2023 General Plastic Surgery/
General Hospital		 6-486 Complete ISO 10535 Third edition 2021-10 Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
05/29/2023 General Plastic Surgery/
General Hospital		 6-487 Partial ANSI AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
05/29/2023 General Plastic Surgery/
General Hospital		 6-488 Complete ASTM F1671/F1671M-22 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
05/29/2023 General Plastic Surgery/
General Hospital		 6-489 Complete IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
05/29/2023 General Plastic Surgery/
General Hospital		 6-490 Complete ISO 10555-6 First edition 2015-04-15 [Including AMD1:2019] Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)]
05/29/2023 General Plastic Surgery/
General Hospital		 6-491 Complete ASTM F1670/F1670M-17a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
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