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U.S. Department of Health and Human Services

Recognized Consensus Standards

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12-165 NEMA XR 22-2006 "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography 09/09/2008 Radiology
12-166 NEMA XR 23-2006 "Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography 09/09/2008 Radiology
14-439 AAMI ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities 07/09/2014 Sterility
4-184 ANSI ASA S3.25-2009 (Revision of ANSI S3.25-1989) (Reaffirmed 2014) American National Standard For an Occluded Ear Simulator 08/14/2015 Dental/ENT
14-495 USP 39-NF34:2016 <1035> Biological Indicators for Sterilization 06/27/2016 Sterility
14-477 USP 38-NF33:2015 <151> Pyrogen Test (USP Rabbit Test) 08/14/2015 Sterility
14-488 USP 39-NF34:2016 <161> Transfusion and Infusion Assemblies and Similar Medical Devices 06/27/2016 Sterility
14-494 USP 39-NF34:2016 <55> Biological Indicators -- Resistance Performance Tests 06/27/2016 Sterility
14-485 USP 39-NF34:2016 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 06/27/2016 Sterility
14-493 USP 39-NF34:2016 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms 06/27/2016 Sterility
14-486 USP 39-NF34:2016 <71> Sterility Tests 06/27/2016 Sterility
14-487 USP 39-NF34:2016 <85> Bacterial Endotoxins Test 06/27/2016 Sterility
6-371 USP 39-NF 33:2016 <861> Sutures - Diameter 06/27/2016 General Plastic Surgery/General Hospital
2-215 USP 38-NF33:2015 <87> Biological Reactivity Test, In Vitro -- Direct Contact Test 08/14/2015 Biocompatibility
2-216 USP 38-NF33:2015 <87> Biological Reactivity Test, In Vitro -- Elution Test 08/14/2015 Biocompatibility
6-372 USP 39-NF33:2016 <871> Sutures - Needle Attachment 06/27/2016 General Plastic Surgery/General Hospital
2-218 USP 38-NF33:2015 <88> Biological Reactivity Test, In Vitro, Classification of Plastics -- Intracutaneous Test 08/14/2015 Biocompatibility
2-219 USP 38-NF33:2015 <88> Biological Reactivity Tests, In Vivo, Classification of Plastics -- Systemic Injection Test 08/14/2015 Biocompatibility
2-217 USP 38-NF33:2015 <88> Biological Reactivity Tests, In Vivo, Procedure Preparation of Sample 08/14/2015 Biocompatibility
6-370 USP 39-NF 33:2016 <881> Tensile Strength 06/27/2016 General Plastic Surgery/General Hospital
7-89 CLSI C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard (2000) ISBN1-56238-398-1 03/08/2004 InVitro Diagnostics
19-5 AAMI ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) 07/09/2014 General II (ES/EMC)
7-197 CLSI M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition 08/20/2012 InVitro Diagnostics
6-375 USP 39-NF33:2016 Absorbable Surgical Suture 06/27/2016 General Plastic Surgery/General Hospital
12-232 NEMA MS 4-2010 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices 03/16/2012 Radiology
12-139 NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment - Revision 3 04/04/2016 Radiology
12-105 NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 03/16/2012 Radiology
3-89 ISO 27186 First edition 2010-03-15 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements 03/18/2011 Cardiovascular
3-109 AAMI ANSI ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements 01/15/2013 Cardiovascular
3-128 AAMI ANSI ISO 14117:2012 Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices 07/09/2014 Cardiovascular
3-139 ISO 14117 First edition 2012-07-15 Active Implantable Medical Devices -- Electromagnetic Compatibility -- EMC Test Protocols For Implantable Cardiac Pacemakers, Implantable Cardioverter Defibrillators, And Cardiac Resynchronization Devices 08/14/2015 Cardiovascular
8-434 ASTM ISO 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology. 06/27/2016 Materials
4-50 ADA ANSI Specification No.18 Alginate Impression Materials: 1992 01/30/2014 Dental/ENT
12-235 IEC 60731 Edition 3.0 2011-02 Amendment 1, Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy 03/16/2012 Radiology
4-186 ANSI ASA S12.2-2008 (Revision of ANSI S12.2-1995) American National Standard Criteria for Evaluating Room Noise 03/16/2012 Dental/ENT
4-173 ANSI S3.44-1996 Reaffirmed by ANSI on 27 April 2006 American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment 03/16/2012 Dental/ENT
10-92 ANSI Z80.20-2010 American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physical Properties 01/27/2015 Ophthalmic
10-93 ANSI Z80.27-2014 American National Standard for Ophthalmics - Implantable Glaucoma Devices 01/27/2015 Ophthalmic
10-73 ANSI Z80.21-2010 (R2015) American National Standard for Ophthalmics - Instruments - General - Purpose Clinical Visual Acuity Charts 04/04/2016 Ophthalmic
10-84 ANSI Z80.11-2012 American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping 01/30/2014 Ophthalmic
10-56 ANSI Z80.12-2007 (R2012) American National Standard for Ophthalmics - Multifocal Intraocular Lenses 01/30/2014 Ophthalmic
10-57 ANSI Z80.13-2007 (R2012) American National Standard for Ophthalmics - Phakic Intraocular Lenses 01/30/2014 Ophthalmic
10-69 ANSI Z80.18-2010 American National Standard for Ophthamics - Contact Lens Care Products - Vocabulary, Performance Specifications and Test Methodology 01/30/2014 Ophthalmic
4-177 ANSI ASA S12.65-2006 (Reaffirmed 2011) American National Standard For Rating Noise with Respect to Speech Interference 07/09/2014 Dental/ENT
16-176 ANSI RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs 01/30/2014 Physical Medicine
16-168 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1 Determination of static stability 01/30/2014 Physical Medicine
16-178 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies 01/30/2014 Physical Medicine
16-179 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces 01/30/2014 Physical Medicine
16-181 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling 01/30/2014 Physical Medicine
16-182 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts - Requirements and test methods 01/30/2014 Physical Medicine
 
 
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