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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-148 Complete ISO CIE 11664-6 Second edition 2022-08 Colorimetry - Part 6: CIEDE2000 colour-difference formula
07/06/2020 Materials 8-536 Complete ISO ASTM 52902:First Edition 2019-07 Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
08/14/2015 Ophthalmic 10-99 Complete ISO 4311 First edition 1979-06-01 Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring
12/18/2023 Dental/
ENT		 4-311 Complete ISO 9917-2 Third edition 2017-09 Dentistry - Water-based cements - Part 2: Resin-modified cements
01/30/2014 Dental/
ENT		 4-151 Complete ISO 22112 First edition 2005-11-01 Dentistry - Artificial teeth for dental prostheses
ANSI ADA Standard No. 15-2008 (R2013) Artificial Teeth for Dental Prostheses
01/30/2014 Dental/
ENT		 4-188 Complete ISO 9917-2 Second edition 2010-04-15 Dentistry - Water-based cements - Part 2: Resin-modified cements
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-149 Complete IEC 60601-2-39 Edition 3.0 2018-04 Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
05/29/2023 Radiology 12-351 Complete IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
12/18/2023 Dental/
ENT		 4-313 Complete ISO 27020 Second edition 2019-06 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2020 Orthodontic Brackets and Tubes
12/23/2019 Radiology 12-329 Complete IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
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