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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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(click for recognition information)
 
08/02/2011 Ophthalmic 10-65 Complete ISO 15752 Second edition 2010-01-15 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
08/02/2011 Ophthalmic 10-66 Complete ISO 10936-2 Second edition 2010-01-15 Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
03/16/2012 Anesthesiology 1-62 Complete ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
ANSI AAMI ISO 5356-1:2004 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
03/16/2012 Anesthesiology 1-72 Complete ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
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
03/16/2012 Anesthesiology 1-75 Complete ISO 5362 Fourth edition 2006-06-01 Anaesthetic Reservoir Bags
ANSI AAMI ISO 5362:2006 Anaesthetic Reservoir Bags
03/16/2012 Cardiovascular 3-96 Complete ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
ANSI AAMI ISO 81060-1:2007/(R)2013 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
03/16/2012 Dental/
ENT
4-173 Complete ANSI ASA S3.44-1996 (Reaffirmed 2006) American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
03/16/2012 General Plastic Surgery/
General Hospital
6-177 Complete ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
03/16/2012 General Plastic Surgery/
General Hospital
6-268 Complete ASTM F921-10 (Reapproved 2018) Standard Terminology Relating to Hemostatic Forceps
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