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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2023 General Plastic Surgery/
General Hospital		 6-492 Complete ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks
12/18/2023 Dental/
ENT		 4-309 Complete ISO 6877 Third edition 2021-09 Dentistry - Endodontic obturating materials
ANSI ADA Standard No. 78-2021 Dentistry - Endodontic Obturating Materials
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-128 Complete ISO CIE 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula
07/09/2014 Radiology 12-280 Complete IEC 62555 Edition 1.0 2013-11 Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
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
06/07/2018 Tissue Engineering 15-54 Complete ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
05/29/2023 Sterility 14-584 Complete ASTM F2391-22 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
08/21/2017 Biocompatibility 2-246 Complete ASTM F1877-16 Standard Practice for Characterization of Particles
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