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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2024 Cardiovascular 3-193 Complete ISO 12417-1 Second edition 2024-02 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
05/26/2025 General Plastic Surgery/
General Hospital		 6-512 Complete IEC 60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
06/07/2021 Dental/
ENT		 4-278 Complete ISO 4823 Fifth edition 2021-02 Dentistry - Elastomeric impression and bite registration materials
ANSI ADA Standard No. 19-2022 Elastomeric Impression and Bite Registration
05/29/2023 Orthopedic 11-399 Complete ASTM F1357-23 Standard Specification for Articulating Total Wrist Implants
03/16/2012 Anesthesiology 1-73 Complete ISO 10651-4 First edition 2002-03-01 Lung ventilators - Part 4: Particular requirements for operator powered resuscitators
12/18/2023 Orthopedic 11-408 Complete ASTM F2777-23 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
06/27/2016 Cardiovascular 3-143 Complete ISO 12417-1 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
04/04/2016 Software/
Informatics		 13-81 Complete ISO IEEE 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
IEEE Std 11073-10419:2015 Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
05/29/2023 InVitro Diagnostics 7-316 Complete CLSI NBS01 7th Edition Dried Blood Spot Specimen Collection for Newborn Screening
09/11/2023 Orthopedic 11-400 Complete ISO 21536 Third edition 2023-07 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
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