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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/09/2014 Anesthesiology 1-100 Complete CGA V-1:2013 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
09/17/2018 Sterility 14-294 Complete ANSI AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
09/17/2018 Sterility 14-513 Complete ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
09/17/2018 Radiology 12-318 Complete IEC 60601-2-64 Edition 1.0 2014-09 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
09/17/2018 Radiology 12-320 Complete IEC 62667 Edition 1.0 2017-08 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
12/23/2016 Orthopedic 11-317 Complete ASTM F3129-16 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
12/20/2021 Materials 8-565 Complete ASTM F2754/F2754M-21 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
06/27/2016 General Plastic Surgery/
General Hospital		 6-363 Complete 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
12/18/2023 Orthopedic 11-404 Complete ASTM F2887-23 Standard Specification for Total Elbow Prostheses
08/21/2017 Orthopedic 11-321 Complete ASTM F2887-17 Standard Specification for Total Elbow Prostheses
05/29/2024 Radiology 12-361 Complete ICDM IDMS Version 1.2 May 2023 Information Display Measurements Standard
09/21/2016 General Plastic Surgery/
General Hospital		 6-380 Complete 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		 6-382 Complete 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
04/04/2016 General Plastic Surgery/
General Hospital		 6-356 Complete ASTM D5712-15(2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
08/06/2013 Cardiovascular 3-87 Complete ASTM F2477-07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-149 Complete IEC 60601-2-39 Edition 3.0 2018-04 Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
01/14/2019 InVitro Diagnostics 7-286 Complete CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
08/21/2017 Software/
Informatics		 13-89 Complete ISO IEEE 11073-10406 First edition 2012-12-01 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-67 Complete ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
05/29/2024 General I (QS/
RM)		 5-142 Complete ISO 780 Fifth edition 2015-12-01 Packaging - Distribution packaging - Graphical symbols for handling and storage of packages
09/17/2018 Orthopedic 11-335 Complete ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles
04/04/2016 Cardiovascular 3-125 Complete ISO 5841-3 Third edition 2013-04-15 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
09/17/2018 Radiology 12-319 Complete IEC 60601-2-68 Edition 1.0 2014-09 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
09/17/2018 General I (QS/
RM)		 5-42 Complete ASTM D903-98 (Reapproved 2017) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
03/16/2012 General Plastic Surgery/
General Hospital		 6-272 Complete ASTM F2062-00 (Reapproved 2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
01/30/2014 Neurology 17-12 Complete ISO 7197 Third edition 2006-06-01 Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
09/17/2018 Dental/
ENT		 4-247 Complete ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
ANSI ADA Standard No. 84-2020 Laser Welding and Filler Materials in Dentistry
01/14/2019 General Plastic Surgery/
General Hospital		 6-411 Complete ASTM D6499-18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
01/14/2019 Cardiovascular 3-157 Complete ANSI AAMI ISO 25539-1: 2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
01/14/2019 Materials 8-487 Complete ISO ASTM 52910-18 Additive manufacturing - Design - Requirements, guidelines and recommendations
05/29/2023 Sterility 14-584 Complete ASTM F2391-22 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
08/14/2015 General Plastic Surgery/
General Hospital		 6-200 Complete ASTM E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
01/30/2014 General Plastic Surgery/
General Hospital		 6-273 Complete ISO 23908 First edition 2011-06-11 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
08/06/2013 General Plastic Surgery/
General Hospital		 6-179 Complete ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods
08/21/2017 Orthopedic 11-269 Complete ASTM F2423-11 (Reapproved 2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
08/21/2017 Materials 8-428 Complete ASTM F1581-08 (Reapproved 2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
01/27/2015 Dental/
ENT		 4-218 Complete ISO 27020 First edition 2010-12-15 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2012 Orthodontic Brackets and Tubes
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-124 Complete CIE ISO 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers
01/30/2014 Radiology 12-261 Complete ISO IEC 10918-1 First edition 1994-02-15 Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]
01/30/2014 Radiology 12-267 Complete IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment - Coordinates, movements, and scales
08/21/2017 Materials 8-452 Complete ASTM F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
12/23/2016 Orthopedic 11-312 Complete 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 Complete ISO 14242-2 Second edition 2016-09-15 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
05/29/2024 Materials 8-615 Complete ISO ASTM 52926-1 First edition 2023-11 Additive manufacturing of metals - Qualification principles - Part 1: General qualification of operators
09/17/2018 Orthopedic 11-341 Complete ASTM F3140-17 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
09/11/2023 Orthopedic 11-400 Complete ISO 21536 Third edition 2023-07 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
08/21/2017 Software/
Informatics		 13-94 Complete ISO IEEE 11073-10424 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
08/06/2013 Software/
Informatics		 13-49 Complete ISO IEEE 11073-20101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
01/30/2014 Radiology 12-228 Complete IEC 61391-2 Edition 1.0 2010-01 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
12/20/2021 Biocompatibility 2-293 Complete USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Elution Test
08/21/2017 Dental/
ENT		 4-239 Complete ANSI AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
01/14/2019 Biocompatibility 2-141 Complete ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
08/14/2015 Dental/
ENT		 4-220 Complete ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
08/14/2015 Dental/
ENT		 4-184 Complete ANSI ASA S3.25-2009 (Reaffirmed 2019) American National Standard For an Occluded Ear Simulator
08/14/2015 Materials 8-389 Complete ISO 15309 First edition 2013-12-01 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
08/14/2015 Radiology 12-292 Complete IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
06/07/2018 Ophthalmic 10-109 Complete ISO 18369-1 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
07/09/2014 Radiology 12-194 Complete ANSI HPS N43.6-2007 (R2013) Sealed Radioactive Sources - Classification
07/09/2014 Software/
Informatics		 13-15 Complete CLSI AUTO13-A2 (Formerly GP19-A2) Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
07/09/2014 Sterility 14-433 Complete ASTM F2227-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
07/09/2014 Dental/
ENT		 4-97 Complete ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
12/18/2023 Anesthesiology 1-163 Complete ISO 80601-2-72 Second edition 2023-06 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
08/14/2015 Anesthesiology 1-105 Complete ISO 80601-2-72 First edition 2015-04-11 Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
08/21/2017 Biocompatibility 2-247 Complete ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
07/09/2014 Dental/
ENT		 4-160 Complete ANSI ASA S3.1-1999 (Reaffirmed 2023) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
01/14/2019 Materials 8-488 Complete ASTM F3301-18a Standard for Additive Manufacturing - Post Processing Methods - Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion
12/23/2016 General I (QS/
RM)		 5-113 Complete ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
01/27/2015 Sterility 14-165 Complete ISO 14644-5 First edition 2004-08-15 Cleanrooms and associated controlled environments - Part 5: Operations
06/27/2016 Sterility 14-481 Complete 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 14-483 Complete ISO ASTM 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
04/04/2016 Tissue Engineering 15-43 Complete ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
06/27/2016 Materials 8-431 Complete ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
01/30/2014 Sterility 14-412 Complete AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
12/18/2023 Anesthesiology 1-162 Complete ISO 10651-4 Second edition 2023-03 Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
05/29/2024 Software/
Informatics		 13-138 Complete IEEE Std 11073-10700-2022 Health Informatics - Device Interoperability Part 10700: Point-of-Care Medical Device Communication - Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System
12/23/2016 Sterility 14-500 Complete ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
01/14/2019 Orthopedic 11-342 Complete ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
12/20/2021 Biocompatibility 2-292 Complete USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
07/09/2014 Sterility 14-257 Complete ASTM D3078-02 (Reapproved 2021)e1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
12/04/2017 Software/
Informatics		 13-102 Complete IEC TR 80001-2-8 Edition 1.0 2016-05 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
05/29/2023 Radiology 12-347 Complete IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
08/06/2013 Software/
Informatics		 13-60 Complete IEC TS 62443-1-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
08/06/2013 Software/
Informatics		 13-62 Complete IEC TR 62443-3-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
01/30/2014 Dental/
ENT		 4-199 Complete ISO 6876 Third edition 2012-06-01 Dentistry -- Root canal sealing materials
01/30/2014 Physical Medicine 16-27 Complete ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
01/30/2014 Physical Medicine 16-163 Complete ISO 7176-5 Second edition 2008-06-01 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
08/06/2013 General Plastic Surgery/
General Hospital		 6-295 Complete AAMI ANSI BF7:2012 Blood transfusion microfilters
01/30/2014 General Plastic Surgery/
General Hospital		 6-305 Complete ISO 10555-3 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
01/30/2014 Orthopedic 11-232 Complete ISO 7207-1 Third edition 2007-02-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
09/21/2016 Ophthalmic 10-101 Complete 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
12/23/2016 Orthopedic 11-311 Complete ISO 14243-2 Third edition 2016-09-01 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
03/31/2006 Radiology 12-141 Complete IEEE N42.13-2004 Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides
12/23/2016 Tissue Engineering 15-48 Complete 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)
05/29/2024 Materials 8-616 Complete ISO ASTM 52926-2 First edition 2023-11 Additive manufacturing of metals - Qualification principles - Part 2: Qualification of operators for PBF-LB
05/29/2023 General Plastic Surgery/
General Hospital		 6-491 Complete ASTM F1670/F1670M-17a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
08/21/2017 Tissue Engineering 15-49 Complete ASTM F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
08/21/2017 Orthopedic 11-175 Complete ASTM F1582-98 (Reapproved 2016) Standard Terminology Relating to Spinal Implants
08/21/2017 Orthopedic 11-309 Complete ASTM F116-12 (Reapproved 2016) Standard Specification for Medical Screwdriver Bits
08/21/2017 Materials 8-449 Complete ASTM F1058-16 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
01/30/2014 Radiology 12-59 Complete IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
 
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