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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/23/2016 Materials 8-439 ASTM F3001-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
12/23/2016 Materials 8-440 ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
12/23/2016 Materials 8-441 ASTM F3109-16 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
12/23/2016 Materials 8-442 ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
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
12/23/2016 Orthopedic 11-311 ISO 14243-2 Third edition 2016-09-01 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
12/23/2016 Orthopedic 11-312 ISO 7206-4 Third edition 2010-06-15 Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
12/23/2016 Orthopedic 11-314 ISO 14242-2 Second edition 2016-09-15 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
12/23/2016 Orthopedic 11-316 ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
12/23/2016 Orthopedic 11-317 ASTM F3129-16 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
12/23/2016 Orthopedic 11-319 ISO 7206-12 First edition 2016-10-01 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
12/23/2016 Orthopedic 11-320 ISO 7206-13 First edition 2016-07-01 Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
12/23/2016 Physical Medicine 16-199 ISO 7176-28 First edition 2012-10-1 Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
12/23/2016 Radiology 12-303 IEC 61303 Edition 1.0 1994-09 Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)]
12/23/2016 Radiology 12-304 IEC 60731 Edition 3.1 2016-04 Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
12/23/2016 Software/
Informatics
13-85 CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
12/23/2016 Software/
Informatics
13-86 IEC ISO 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
12/23/2016 Software/
Informatics
13-87 IEC ISO 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
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
12/23/2016 Sterility 14-496 ASTM F1608-16 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
12/23/2016 Sterility 14-497 ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
12/23/2016 Sterility 14-499 ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
12/23/2016 Sterility 14-500 ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
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)
09/21/2016 General Plastic Surgery/
General Hospital
6-379 ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test methods
09/21/2016 General Plastic Surgery/
General Hospital
6-380 ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
09/21/2016 General Plastic Surgery/
General Hospital
6-381 ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
09/21/2016 General Plastic Surgery/
General Hospital
6-382 ISO 11608-7 First edition 2016-08-01 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
09/21/2016 InVitro Diagnostics 7-265 CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
09/21/2016 InVitro Diagnostics 7-266 CLSI EP19 2nd Edition (Replaces EP19-R) A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
09/21/2016 Ophthalmic 10-101 ISO 18189 First edition 2016-06-01 Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
07/26/2016 Biocompatibility 2-169 ANSI AAMI ISO 10993-13:2010/(R)2014 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
07/26/2016 Biocompatibility 2-170 ANSI AAMI ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
07/26/2016 Biocompatibility 2-174 ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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
07/26/2016 Biocompatibility 2-213 ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
07/26/2016 Biocompatibility 2-222 ANSI AAMI ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/26/2016 Biocompatibility 2-227 ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
07/26/2016 Biocompatibility 2-228 ANSI AAMI ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
07/26/2016 Biocompatibility 2-237 ANSI AAMI ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
07/26/2016 Biocompatibility 2-240 ANSI AAMI ISO TIR 10993-20:2006 Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO /TS 10993-20 First edition 2006-08-01 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
07/26/2016 Biocompatibility 2-241 ANSI AAMI ISO /TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO /TR 37137 First edition 2014-05-15 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
07/26/2016 Biocompatibility 2-243 ISO /TR 10993-33 First Edition 2015-03-01 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
06/27/2016 Cardiovascular 3-143 ISO 12417 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
06/27/2016 Dental/
ENT
4-86 ANSI ADA Standard No. 38-2000 (R2015) Metal-Ceramic Dental Restorative Systems
06/27/2016 Dental/
ENT
4-139 ANSI ADA Standard No. 48-2004 (R2015) Visible Light Curing Units
06/27/2016 Dental/
ENT
4-202 ANSI ADA Standard No. 58-2010 (R2015) Root Canal Files, Type H (Hedstrom)
06/27/2016 Dental/
ENT
4-227 ANSI ADA Standard No. 134-2018 Metallic Materials for Fixed and Removable Restorations and Appliances
ISO 22674 Second edition 2016-01-15 Dentistry - Metallic materials for fixed and removable restorations and appliances
06/27/2016 Dental/
ENT
4-228 ANSI ASA S3.20-2015 (Reaffirmed 2020) American National Standard Bioacoustical Terminology
06/27/2016 General I (QS/
RM)
5-57 ANSI AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices
06/27/2016 General I (QS/
RM)
5-89 IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
06/27/2016 General I (QS/
RM)
5-108 ISO 80369-6 First Edition 2016-03-15 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
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
06/27/2016 General II (ES/
EMC)
19-15 ANSI AAMI IEC 60601-1-12:2016 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency
IEC 60601-1-12 Edition 1.0 2014-06 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
06/27/2016 General Plastic Surgery/
General Hospital
6-363 ISO 11810 Second edition 2015-12-15 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition
06/27/2016 General Plastic Surgery/
General Hospital
6-364 ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
06/27/2016 General Plastic Surgery/
General Hospital
6-377 ISO 11608-5 First edition 2012-10-01 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated function.
06/27/2016 InVitro Diagnostics 7-264 CLSI MM21-1st Edition (Reaffirmed: January 2020) Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
06/27/2016 Materials 8-217 ASTM F620-11 (Reapproved 2015) Standard Specification Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
06/27/2016 Materials 8-421 ASTM F629-15 Standard Practice for Radiography of Cast Metallic Surgical Implants
06/27/2016 Materials 8-426 ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
06/27/2016 Materials 8-427 ASTM F1185-03 (Reapproved 2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants
06/27/2016 Materials 8-429 ASTM F2224-09 (Reapproved 2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
06/27/2016 Materials 8-430 ISO 13356:2015 Third Edition 2015-09-15 Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
06/27/2016 Materials 8-431 ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
06/27/2016 Materials 8-432 ASTM ISO 52921 First Edition 2013-06-01 Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.
06/27/2016 Materials 8-434 ASTM ISO 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology
06/27/2016 Orthopedic 11-306 ASTM F1814-15 Standard Guide for Evaluating Modular Hip and Knee Joint Components
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
06/27/2016 Orthopedic 11-308 ASTM F3161-16 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
06/27/2016 Radiology 12-293 IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
06/27/2016 Radiology 12-294 IEC 60601-2-45 Edition 3.1 2015 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
06/27/2016 Radiology 12-295 IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
06/27/2016 Radiology 12-297 ANSI IES RP-27.1-2015 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
06/27/2016 Radiology 12-298 NEMA MS 10-2010 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
06/27/2016 Radiology 12-301 IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
06/27/2016 Radiology 12-302 IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
06/27/2016 Software/
Informatics
13-82 ANSI 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
13-83 AAMI TIR57:2016 Principles for medical device security - Risk management.
06/27/2016 Software/
Informatics
13-84 IEEE ISO 11073-10103 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
06/27/2016 Sterility 14-481 ISO 14644-2 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
06/27/2016 Sterility 14-482 ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
06/27/2016 Sterility 14-483 ASTM ISO 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
06/15/2016 Cardiovascular 3-132 ANSI AAMI ISO 27185:2012 Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
06/15/2016 General I (QS/
RM)
5-102 IEC 60417:2002 DB Graphical symbols for use on equipment
06/15/2016 General I (QS/
RM)
5-104 IEC /TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice
04/04/2016 Anesthesiology 1-106 ISO 17510 First Edition 2015-08-01 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
04/04/2016 Anesthesiology 1-115 ISO 80601-2-70 First Edition 2015-01-15 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
04/04/2016 Cardiovascular 3-125 ANSI AAMI ISO 5841-3:2013 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 5841-3 Third edition 2013-04-15 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
04/04/2016 Dental/
ENT
4-190 ANSI ASA S3.35-2010 (Reaffirmed 2020) American National Standard Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
04/04/2016 Dental/
ENT
4-221 ISO 7494-2 Second edition 2015-04-01 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
04/04/2016 Dental/
ENT
4-222 ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants
04/04/2016 Dental/
ENT
4-224 ISO 24234 Second edition 2015-05-01 Dentistry - Dental Amalgam
04/04/2016 General I (QS/
RM)
5-98 ANSI ESD S20.20-2014 Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
04/04/2016 General I (QS/
RM)
5-99 ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
04/04/2016 General II (ES/
EMC)
19-16 ANSI AAMI HA60601-1-11:2015 Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD)
04/04/2016 General II (ES/
EMC)
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 Plastic Surgery/
General Hospital
6-355 ASTM D3772-15 Standard Specification for Industrial Rubber Finger Cots
04/04/2016 General Plastic Surgery/
General Hospital
6-356 ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
04/04/2016 General Plastic Surgery/
General Hospital
6-357 ISO 10555-6 First edition 2015-04-15 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports
 
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