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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)
 
01/30/2014 Dental/
ENT
4-153 Complete ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
01/30/2014 Dental/
ENT
4-180 Complete ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
01/30/2014 Dental/
ENT
4-181 Complete ISO 4049 Fourth edition 2009-10-01 Dentistry - Polymer-based restorative materials
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
01/30/2014 Dental/
ENT
4-198 Complete ISO 3107 Fourth edition 2011-03-01 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
ANSI ADA Standard No. 30-2013 (R2018) Dental Zinc Oxide-Eugenol and Zinc Oxide
01/30/2014 Dental/
ENT
4-199 Complete ISO 6876 Third edition 2012-06-01 Dentistry -- Root canal sealing materials
01/30/2014 General I (QS/
RM)
5-47 Complete ISO 10012 First edition 2003-01-15 Measurement management systems - Requirements for measurement processes and measuring equipment
01/30/2014 General I (QS/
RM)
5-84 Complete AAMI TIR 49:2013/(R)2020 Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments
01/30/2014 General Plastic Surgery/
General Hospital
6-117 Complete ASTM F2172-02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
01/30/2014 General Plastic Surgery/
General Hospital
6-253 Complete ISO 10535 Second edition 2006-12-15 Hoists for the transfer of disabled persons - Requirements and test methods
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