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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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12/19/2022 Radiology 12-349 Complete NEMA PS 3.1 - 3.20 2022d Digital Imaging and Communications in Medicine (DICOM) Set
07/26/2016 Biocompatibility 2-227 Complete ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
05/29/2023 Radiology 12-347 Complete IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
12/18/2023 ObGyn/
Gastroenterology/
Urology		 9-150 Complete ISO 7439 Fourth edition 2023-04 Copper-bearing contraceptive intrauterine devices - Requirements and tests
05/29/2023 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
05/29/2023 Sterility 14-588 Complete AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
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
01/14/2019 Dental/
ENT		 4-248 Complete ISO 10477 Third edition 2018-06 Dentistry - Polymer-based crown and veneering materials
12/18/2023 Dental/
ENT		 4-320 Complete ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
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