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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
Number and Date
 

Title of Standard
 
 
01/30/2014 General I (QS/
RM)
5-47 ISO 10012 First edition 2003-01-15 Measurement management systems - Requirements for measurement processes and measuring equipment
09/09/2008 ObGyn/
Gastroenterology/
Urology
9-7 IEC 61846 First edition 1998-04 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
09/09/2008 Software/
Informatics
13-10 CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
03/16/2012 Radiology 12-242 IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
08/20/2012 InVitro Diagnostics 7-197 CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
08/20/2012 InVitro Diagnostics 7-148 CLSI M28-A2 (Replaces M28-A) Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition.
07/09/2014 Sterility 14-286 ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
01/15/2013 InVitro Diagnostics 7-236 CLSI M43-A Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline.
08/06/2013 Radiology 12-205 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 Dental/
ENT
4-180 ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
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