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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
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)		 5-40 ANSI AAMI ISO 14971:2007/(R)2016 Medical devices - Applications of risk management to medical devices
ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices
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		 6-365 ISO 11040-4 Third edition 2015-04-01 Prefilled syringes - Part 4: Glass barrels for injectables
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 8-422 ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
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
06/27/2016 Materials 8-424 ASTM F2695-12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
06/27/2016 Materials 8-425 ASTM F2820-12 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
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 11-305 ASTM F1781-15 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
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 12-299 IEC 62563-1 Edition 1.1 2016-03 CONSOLIDATED VERSION Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
06/27/2016 Radiology 12-300 NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set
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 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
06/27/2016 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
06/27/2016 Tissue Engineering 15-46 ISO 22442-2 Second edition 2015-11-01 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling.
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 Cardiovascular 3-133 ANSI AAMI ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 5840-3 First edition 2013-03-01 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
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
04/04/2016 General Plastic Surgery/
General Hospital		 6-358 ISO 8536-8 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus
04/04/2016 General Plastic Surgery/
General Hospital		 6-359 ISO 8536-9 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment
04/04/2016 General Plastic Surgery/
General Hospital		 6-360 ISO 8536-10 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
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
04/04/2016 InVitro Diagnostics 7-259 CLSI GP23-A2 (Replaces GP23-A) Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition
04/04/2016 InVitro Diagnostics 7-260 CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
04/04/2016 Materials 8-103 ASTM F1801-97 (Reapproved 2014) Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
04/04/2016 Materials 8-107 ASTM F746-04 (Reapproved 2014) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
04/04/2016 Materials 8-114 ASTM F2255-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading
04/04/2016 Materials 8-115 ASTM F2256-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
04/04/2016 Materials 8-116 ASTM F2258-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
04/04/2016 Materials 8-121 ASTM F2005-05 (Reapproved 2015) Standard Terminology for Nickel-Titanium Shape Memory Alloys
04/04/2016 Materials 8-135 ASTM F2392-04 (Reapproved 2015) Standard Test Method for Burst Strength of Surgical Sealants
04/04/2016 Materials 8-136 ASTM F2458-05 (Reapproved 2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
04/04/2016 Materials 8-200 ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
04/04/2016 Materials 8-393 ASTM F1350-15 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
04/04/2016 Materials 8-394 ASTM F1472-14 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
04/04/2016 Materials 8-398 ASTM F1108-14 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
04/04/2016 Materials 8-399 ASTM F90-14 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
04/04/2016 Materials 8-400 ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
04/04/2016 Materials 8-401 ASTM F2118-14 (Reapproved 2020) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
04/04/2016 Materials 8-403 ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
04/04/2016 Materials 8-404 ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates
04/04/2016 Materials 8-405 ISO 5832-4 Third edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
04/04/2016 Materials 8-406 ISO 5832-11 Second edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
 
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