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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
2-232 USP 39-NF34:2016 <151> Pyrogen Test (USP Rabbit Test) 07/26/2016 Biocompatibility
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
2-229 USP 39-NF34:2016 <87> Biological Reactivity Test, In Vitro -- Direct Contact Test 07/26/2016 Biocompatibility
2-230 USP 39-NF34:2016 <87> Biological Reactivity Test, In Vitro -- Elution Test 07/26/2016 Biocompatibility
6-372 USP 39-NF33:2016 <871> Sutures - Needle Attachment 06/27/2016 General Plastic Surgery/General Hospital
2-231 USP 39-NF34:2016 <88> Biological Reactivity Tests, In Vivo, Procedure Preparation of Sample 07/26/2016 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
16-183 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the performance of stand-up type wheelchairs 01/30/2014 Physical Medicine
16-187 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary 01/30/2014 Physical Medicine
16-172 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space 01/30/2014 Physical Medicine
16-174 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions 01/30/2014 Physical Medicine
16-175 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths 01/30/2014 Physical Medicine
16-184 ANSI RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up procedures 01/30/2014 Physical Medicine
16-185 ANSI RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters 01/30/2014 Physical Medicine
16-177 ANSI RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs 01/30/2014 Physical Medicine
16-180 ANSI RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs ¿ Requirements and test methods 01/30/2014 Physical Medicine
16-169 ANSI RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs 01/30/2014 Physical Medicine
16-170 ANSI RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes 01/30/2014 Physical Medicine
16-173 ANSI RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs 01/30/2014 Physical Medicine
4-165 ANSI S3.13-1987 (Reaffirmed 2012) American National Standard Mechanical Coupler for Measurement of Bone Vibrators 07/09/2014 Dental/ENT
4-183 ANSI S3.2-2009 (Reaffirmed 2014) American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems 01/27/2015 Dental/ENT
4-163 ANSI S3.5-1997 (Reaffirmed 2012) American National Standard Methods for Calculation of the Speech Intelligibility Index 07/09/2014 Dental/ENT
4-216 ANSI IEEE C63:19-2011 American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids 01/27/2015 Dental/ENT
4-211 ANSI S3.46-2013 American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids 07/09/2014 Dental/ENT
4-171 ANSI S3.37-1987 (Reaffirmed 2012) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids 07/09/2014 Dental/ENT
4-185 ANSI S3.45-2009 (Reaffirmed 2014) American National Standard Procedures for Testing Basic Vestibular Function 01/27/2015 Dental/ENT
19-17 ANSI IEEE C63.18-2014 American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters 04/04/2016 General II (ES/EMC)
4-217 ANSI S3.36-2012 American National Standard Specification for a Manikin for Simulated in situ Airborne Acoustic Measurements 01/27/2015 Dental/ENT
4-220 ANSI ASA S3.22-2014 American National Standard Specification of Hearing Aid Characteristics 08/14/2015 Dental/ENT
4-90 ANSI S3.39:1987 (Reaffirmed by ANSI June 15, 2012) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) 08/05/2013 Dental/ENT
4-204 ANSI ASA IEC S3.42-2012/Part 2/ IEC 60118-15:2012 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) 08/05/2013 Dental/ENT
4-228 ANSI ASA S3.20-2015 (Revision of ANSI S3.20-1995) American National Standard: Bioacoustical Terminology 06/27/2016 Dental/ENT
1-107 AAMI ANSI ISO 5356-1:2004 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets 04/04/2016 Anesthesias
1-62 ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets 03/16/2012 Anesthesias
1-108 AAMI ANSI ISO 5361:2012 Anaesthetic and Respiratory Equipment - Tracheal Tubes and Connectors 04/04/2016 Anesthesias
1-79 ISO 26825 First edition 2008-08-15 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance 03/16/2012 Anesthesias
1-103 ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment -- Breathing sets and connectors 08/14/2015 Anesthesias
1-93 ISO 5361 Second edition 2012-10-01 Anaesthetic and respiratory equipment -- Tracheal tubes and connectors 04/04/2016 Anesthesias
1-111 AAMI ANSI ISO 5366-3:2001 Anaesthetic and Respiratory Equipment -- Tracheostomy Tubes - Part 3: Paediatric Tracheostomy Tubes 04/04/2016 Anesthesias
1-44 ISO 5366-1 Fourth edition 2000-12-15 Anaesthetic and respiratory equipment -- Tracheostomy tubes -- Part 1: Tubes and connectors for use in adults 01/30/2014 Anesthesias
1-110 AAMI ANSI ISO 5366-1:2000 Anaesthetic and respiratory equipment -- Tracheostomy tubes -- Part 1: Tubes and connectors for use in adults 04/04/2016 Anesthesias
1-95 ISO 5366-3 Second edition 2001-08-15 Anaesthetic and respiratory equipment -- Tracheostomy tubes -- Part 3: Pediatric tracheostomy tubes [Including: Technical Corrigendum 1 (2003)] 01/30/2014 Anesthesias
1-75 ISO 5362 Fourth edition 2006-06-01 Anaesthetic Reservoir Bags 03/16/2012 Anesthesias
1-109 AAMI ANSI ISO 5362:2006 Anaesthetic Reservoir Bags 04/04/2016 Anesthesias
1-116 ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems 06/27/2016 Anesthesias
5-39 IEC 60812 Second edition 2006-01 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) 03/16/2012 General I (QS/RM)
7-206 CLSI I/LA20-A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline - Second Edition 08/05/2013 InVitro Diagnostics
1-47 AS 4259-1995 Ancillary devices for expired air resuscitation 01/30/2014 Anesthesias
10-99 ISO 4311 First edition 1979-06-01 Anionic and non-ionic surface active agents ¿ Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring 08/14/2015 Ophthalmic
7-175 CLSI C59-A (Formerly I/LA15-A) Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline 07/09/2014 InVitro Diagnostics
13-35 AAMI ANSI SW87:2012 Application of quality management system concepts to medical device data systems 01/15/2013 Software/Informatics
13-38 IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT - networks incorporating medical devices - Part 1: Roles, responsibilities and activities 08/05/2013 Software/Informatics
13-39 AAMI ANSI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities 08/05/2013 Software/Informatics
13-42 IEC TR 80001-2-2 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls 08/05/2013 Software/Informatics
13-43 AAMI ANSI IEC TIR 80001-2-2:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls 08/05/2013 Software/Informatics
13-44 IEC TR 80001-2-3 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks 08/05/2013 Software/Informatics
13-45 AAMI ANSI IEC TIR80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks 08/05/2013 Software/Informatics
13-82 AAMI ISO /TIR 80001-2-6: 2014 Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements. 06/27/2016 Software/Informatics
13-40 IEC 80001-2-1 Edition 1.0 2012-07 Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples 08/05/2013 Software/Informatics
 
 
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