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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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08/20/2012 InVitro Diagnostics 7-76 Complete CLSI M15-A (Replaces M15-T) Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
01/15/2013 InVitro Diagnostics 7-235 Complete CLSI EP25-A (Replaces EP25-P) Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
08/06/2013 Cardiovascular 3-87 Complete ASTM F2477-07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability
08/06/2013 Dental/
ENT		 4-204 Complete ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
08/06/2013 General Plastic Surgery/
General Hospital		 6-296 Complete ANSI AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
08/06/2013 Ophthalmic 10-77 Complete ISO 9394 Third edition 2012-10-01 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
08/06/2013 Orthopedic 11-252 Complete ISO 5838-1 Third edition 2013-03-01 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
08/06/2013 Radiology 12-205 Complete IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
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 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
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