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U.S. Department of Health and Human Services

Recognized Consensus Standards
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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
08/14/2015 Orthopedic 11-266 ASTM F2665-09 (Reapproved 2014) Standard Specification for Total Ankle Replacement Prosthesis
08/06/2013 InVitro Diagnostics 7-242 CLSI C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
12/23/2016 Tissue Engineering 15-48 ASTM F2605-16 Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
06/07/2018 General Plastic Surgery/
General Hospital		 6-214 ASTM D6355-07 (Reapproved 2017) Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
06/07/2018 Radiology 12-314 ISO 11554 Fourth edition 2017-07 Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics
01/30/2014 Materials 8-159 ISO 9584 First edition 1993-10-15 Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants
01/27/2015 Sterility 14-243 ISO 14644-6 First edition 2007-07-15 Cleanrooms and associated controlled environments - Part 6: Vocabulary
08/14/2015 General Plastic Surgery/
General Hospital		 6-354 ASTM D7907-14 (Reapproved 2019) Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
12/23/2016 Sterility 14-169 ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
01/30/2014 Sterility 14-404 ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
12/23/2016 Materials 8-444 ISO 17296-2 First edition 2015-01-15 Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock
09/21/2016 Ophthalmic 10-102 ANSI Z80.36-2016 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
06/27/2016 Cardiovascular 3-143 ISO 12417 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
04/04/2016 Dental/
ENT		 4-225 ISO 4823 Fourth edition 2015-08-01 Dentistry - Elastometric impression materials
01/27/2015 Cardiovascular 3-88 ASTM F2514-08 (Reapproved 2014) Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial
08/14/2015 Sterility 14-463 ASTM ISO 51608 Second edition 2015-03-15 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
08/06/2013 Materials 8-338 ASTM F139-12 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
03/16/2012 Sterility 14-332 ANSI AAMI ISO 11140-5:2007/(R)2012 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
ISO 11140-5 Second edition 2007-03-15 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
06/07/2018 Materials 8-464 ISO \TS 10974 Second edition 2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
06/07/2018 General Plastic Surgery/
General Hospital		 6-270 ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles
09/17/2018 Orthopedic 11-325 ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
08/21/2017 Sterility 14-361 ANSI AAMI ISO 14160:2011/ (R)2016 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 14160 Second edition 2011-07-01 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
08/14/2015 Sterility 14-460 ANSI AAMI ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part 1: General requirements
09/17/2018 Orthopedic 11-310 ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-119 IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
08/21/2017 General Plastic Surgery/
General Hospital		 6-387 ANSI AAMI IEC 60601-2-50:2009/A1:2016 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
IEC 60601-2-50 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
09/17/2018 Orthopedic 11-322 ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
07/26/2016 Biocompatibility 2-167 ANSI AAMI ISO TIR 10993-19:2006 Biological evaluation of medical devices - Part 19: Physicochemical, morphological, and topographical characterization of materials
ISO /TS 10993-19 First edition 2006-06-01 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological, and topographical characterization of materials
04/04/2016 General Plastic Surgery/
General Hospital		 6-361 ISO 8536-11 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
06/07/2018 Anesthesiology 1-134 ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
01/14/2019 Orthopedic 11-344 ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
01/14/2019 General Plastic Surgery/
General Hospital		 6-410 ISO 8536-6 Third edition 2016-12-01 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
07/26/2016 Biocompatibility 2-191 ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-118 ANSI AAMI ISO 8637:2010 (R2015) Cardiovascular implants and extracorporeal systems--Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
ISO 8637-1 First edition 2017-11 Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01/30/2014 Physical Medicine 16-178 ANSI RESNA WC-1:2009 Section 11 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies
07/15/2019 Tissue Engineering 15-58 ASTM F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
06/27/2016 Materials 8-423 ASTM F2565-13 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
08/21/2017 Orthopedic 11-280 ASTM F2624-12 (Reapproved 2016) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
01/14/2019 Software/
Informatics		 13-107 IEEE Std 11073-20702-2016 Health informatics - Point-of-care medical device communication Part 20702: Medical Devices
ISO 11073-20702 First edition 2018-09 Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
07/15/2019 General I (QS/
RM)		 5-115 ISO 80369-7 First edition 2016-10-15 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
06/27/2016 Orthopedic 11-307 ASTM F2385-15 (Reapproved 2019) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
01/30/2014 General I (QS/
RM)		 5-84 AAMI TIR 49:2013/(R)2020 Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments
04/04/2016 Materials 8-402 ASTM F688-14 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
07/06/2020 General I (QS/
RM)		 5-127 ISTA 3B 2017 Packaged-Products for Less-Than-Truckload (LTL) Shipment
07/26/2016 Biocompatibility 2-227 ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
01/14/2019 Orthopedic 11-342 ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
09/21/2016 General I (QS/
RM)		 5-112 ISTA 3E 2009 Unitized Loads of Same Product
01/14/2019 Dental/
ENT		 4-252 ISO 10650 Second edition 2018-08 Dentistry - Powered polymerization activators
01/14/2019 Biocompatibility 2-141 ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
08/21/2017 Dental/
ENT		 4-232 ISO 20795-1 Second edition 2013-03-01 Dentistry - Base polymers - Part 1: Denture base polymers
12/23/2016 General I (QS/
RM)		 5-113 ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
12/23/2019 Physical Medicine 16-212 ANSI RESNA WC-2:2019 Section 6 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs.
03/16/2012 Tissue Engineering 15-36 ASTM F2383-11 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
07/09/2014 General II (ES/
EMC)		 19-9 IEC 60601-1-10 Edition 1.1 2013-11 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
06/07/2018 ObGyn/
Gastroenterology/
Urology		 9-114 IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
09/17/2018 Ophthalmic 10-56 ANSI Z80.12-2007 (R2017) American National Standard for Ophthalmics - Multifocal Intraocular Lenses
06/27/2016 General II (ES/
EMC)		 19-14 IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
07/09/2014 Software/
Informatics		 13-65 ANSI UL 1998 Third Edition 2013 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
12/23/2019 General Plastic Surgery/
General Hospital		 6-438 IEC 80601-2-77 Edition 1.0 2019-07 Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
06/27/2016 Tissue Engineering 15-45 ISO 22442-1 Second edition 2015-11-01 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
12/23/2019 Physical Medicine 16-207 ANSI RESNA WC-1:2019 Section 1 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability
07/09/2014 General Plastic Surgery/
General Hospital		 6-180 ASTM F2407-06 (Reapproved 2013) Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
08/06/2013 Software/
Informatics		 13-38 ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
12/23/2019 Materials 8-522 ASTM F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
01/27/2015 Radiology 12-287 NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT
07/09/2014 Tissue Engineering 15-39 ASTM F2150-13 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissued-Engineered Medical Products
01/30/2014 Anesthesiology 1-98 ISO 80601-2-12 First edition 2011-04-15 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)]
04/04/2016 Anesthesiology 1-106 ISO 17510 First Edition 2015-08-01 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
08/21/2017 Tissue Engineering 15-50 ASTM F2739-16 Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
08/14/2015 Orthopedic 11-292 ISO 14243-3 Second edition 2014-11-01 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
07/06/2020 General Plastic Surgery/
General Hospital		 6-178 ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
07/06/2020 Software/
Informatics		 13-114 IEEE Std 11073-10101-2019 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
07/06/2020 Cardiovascular 3-160 ANSI AAMI ISO 81060-2:2019 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
07/15/2019 Anesthesiology 1-126 ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
12/23/2019 Software/
Informatics		 13-110 IEEE ISO 11073-10101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature [Including AMENDMENT 1 (2017)]
04/04/2016 Sterility 14-327 ANSI AAMI ISO 11737-2:2009/(R)2014 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-2 Second edition 2009-11-15 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
07/15/2019 Biocompatibility 2-266 ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
07/15/2019 Anesthesiology 1-144 ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
08/06/2013 Sterility 14-382 ASTM ISO 51276 Second edition 2012-07-15 Practice for use of a polymethylmethacrylate dosimetry system
07/15/2019 InVitro Diagnostics 7-290 CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
07/15/2019 InVitro Diagnostics 7-291 CLSI EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
07/06/2020 Cardiovascular 3-168 IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [including: Amendment 1 (2019)]
01/14/2019 Radiology 12-324 ISO 13694 Third edition 2018-11 Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-121 ANSI AAMI IEC 60601-2-16 :2012 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
IEC 60601-2-16 Edition 5.0 2018-4 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
01/14/2019 General I (QS/
RM)		 5-122 ASME V&V 40-2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices
01/30/2014 Materials 8-359 ASTM F2038-00 (Reapproved 2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part 1: Formulations and Uncured Materials
12/23/2019 Materials 8-480 ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
12/23/2019 Materials 8-481 ASTM F1314-18 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
12/23/2019 Materials 8-484 ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
08/21/2017 Ophthalmic 10-104 ANSI Z80.20-2016 American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties
 
 
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