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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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08/06/2013 Sterility 14-388 Complete ISO 13408-7 First edition 2012-08-01 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
ANSI AAMI ISO 13408-7:2012 (R2018) Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
08/06/2013 Tissue Engineering 15-14 Complete ASTM F2603-06 (Reapproved 2020) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
01/14/2014 Radiology 12-268 Complete IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
01/30/2014 Anesthesiology 1-81 Complete CGA V-5:2008 (Reaffirmed 2013) Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
01/30/2014 Anesthesiology 1-97 Complete CGA V-7.1:2011 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
01/30/2014 Cardiovascular 3-54 Complete ANSI AAMI ISO 7198:2016 Second edition Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches
01/30/2014 Cardiovascular 3-63 Complete ISO 11318:2002 Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements.
01/30/2014 Cardiovascular 3-118 Complete ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
01/30/2014 Dental/
ENT		 4-137 Complete ISO 6877 Second edition 2006-04-01 Dentistry - Root-canal obturating points
ANSI ADA Standard No. 78-2013 Dental obturating cones
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
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