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U.S. Department of Health and Human Services

Recognized Consensus Standards
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07/09/2014 Dental/
ENT		 4-97 ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
01/30/2014 Physical Medicine 16-165 ISO 7176-14 Second edition 2008-02-15 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-85 ASTM D6976-13R18 Standard Specification for Rubber Contraceptives - Vaginal Diaphragms
07/09/2014 Materials 8-377 ASTM F136-13 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
07/09/2014 ObGyn/
Gastroenterology/
Urology		 9-94 ISO 8600-4 Second Edition 2014-03-15 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
07/09/2014 Orthopedic 11-276 ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
07/06/2020 Sterility 14-545 ASTM ISO 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
07/06/2020 Sterility 14-549 ASTM F3004-13 (Reapproved 2020) Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
07/15/2019 Sterility 14-528 ANSI AAMI ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
ISO 11137-1 First edition 2006-04-15 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
04/04/2016 General I (QS/
RM)		 5-99 ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
07/09/2014 Software/
Informatics		 13-69 IEEE ISO 11073-10472 First edition 2012-11-01 Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor
07/09/2014 Sterility 14-434 ASTM F2228-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
07/09/2014 Sterility 14-256 ASTM F2095-07 (Reapproved 2021) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
07/09/2014 Sterility 14-435 ASTM F2251-13 (Reapproved 2018) Standard Test Method for Thickness Measurement of Flexible Packaging Material
07/09/2014 Sterility 14-290 ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
01/14/2019 Anesthesiology 1-120 ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
01/14/2019 General Plastic Surgery/
General Hospital		 6-338 ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves
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
06/27/2016 Orthopedic 11-306 ASTM F1814-15 Standard Guide for Evaluating Modular Hip and Knee Joint Components
08/14/2015 General I (QS/
RM)		 5-97 ANSI AAMI ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ISO 80369-20 First edition 2015-05-15 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
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		 6-381 ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
08/14/2015 ObGyn/
Gastroenterology/
Urology		 9-108 ISO 8009 Second edition 2014-11-15 Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
06/07/2018 Neurology 17-16 IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
05/30/2022 Materials 8-587 ISO 5832-3 Fifth Edition 2021-11 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
01/14/2019 InVitro Diagnostics 7-139 CLSI QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-122 ISO 25841 Third edition 2017-08 Female condoms -- Requirements and test methods
07/06/2020 Materials 8-532 ASTM F3335-20 Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
07/06/2020 Materials 8-533 ASTM ISO 52907: First Edition 2019-11 Additive Manufacturing - Feedstock materials - Methods to characterize metal powders
07/06/2020 Tissue Engineering 15-59 ASTM F2450-18 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
08/21/2017 General II (ES/
EMC)		 19-24 IEC 60086-5 Edition 4.0 2016-07 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
08/21/2017 General II (ES/
EMC)		 19-26 IEC 62485-2 Edition 1.0 2010-06 Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries.
08/21/2017 General II (ES/
EMC)		 19-28 IEC 62485-4 Edition 1.0 2015-01 Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances
08/21/2017 Radiology 12-306 NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications
08/21/2017 InVitro Diagnostics 7-270 CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3) Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
08/21/2017 InVitro Diagnostics 7-273 CLSI M58 1st Edition Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
01/30/2014 Radiology 12-228 IEC 61391-2 Edition 1.0 2010-01 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
01/30/2014 Radiology 12-261 IEC ISO 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 IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment - Coordinates, movements, and scales
04/04/2016 Radiology 12-195 NEMA MS 6-2008 (R2014) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
07/09/2014 Radiology 12-273 IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
06/07/2018 General Plastic Surgery/
General Hospital		 6-401 ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
06/07/2018 General Plastic Surgery/
General Hospital		 6-270 ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles
09/17/2018 Materials 8-472 ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
09/17/2018 Materials 8-474 ASTM F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
01/14/2019 InVitro Diagnostics 7-286 CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
01/14/2019 InVitro Diagnostics 7-285 CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
01/14/2019 Materials 8-489 ASTM F3302-18 Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion
06/07/2018 Tissue Engineering 15-53 ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
06/07/2018 Cardiovascular 3-150 ANSI AAMI ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
06/07/2018 Materials 8-463 ASTM ISO 52901 First edition 2017-08 Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts
09/17/2018 Materials 8-412 ASTM F2537-06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
06/07/2018 General Plastic Surgery/
General Hospital		 6-405 IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
07/15/2019 General Plastic Surgery/
General Hospital		 6-129 ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
12/23/2016 Biocompatibility 2-93 ASTM F763-04 (Reapproved 2016) Standard Practice for Short-Term Screening of Implant Materials
08/21/2017 Biocompatibility 2-247 ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
06/07/2018 General Plastic Surgery/
General Hospital		 6-406 ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
09/17/2018 Materials 8-476 ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
09/17/2018 Materials 8-479 ISO 13781 Second edition 2017-07 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
09/17/2018 Orthopedic 11-324 ASTM F366-17 Standard Specification for Fixation Pins and Wires
09/17/2018 Orthopedic 11-325 ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
08/06/2013 Software/
Informatics		 13-61 IEC 62443-2-1 Edition 1.0 2010-11 Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program
01/14/2019 Anesthesiology 1-117 ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
12/23/2016 Anesthesiology 1-118 ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/21/2020 Materials 8-552 ASTM F3434-20 Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing
01/14/2019 InVitro Diagnostics 7-178 CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
12/23/2019 General I (QS/
RM)		 5-125 ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
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
07/15/2019 Materials 8-518 ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
12/23/2019 Sterility 14-538 ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
12/23/2019 Radiology 12-309 IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
12/23/2019 Radiology 12-327 ISO 11551 Third eidtion 2019-10 Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components
12/23/2019 General II (ES/
EMC)		 19-33 IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
07/06/2020 Tissue Engineering 15-62 ASTM F2602-18 Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
07/06/2020 Dental/
ENT		 4-263 ISO 9693 Third edition 2019-10 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
12/23/2019 General II (ES/
EMC)		 19-32 IEC 62133-1 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-68 ISO 23409 First edition 2011-02-15 Male Condoms - Requirements and test methods for condoms made from synthetic materials
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-111 ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms - Requirements and test methods
01/14/2019 Orthopedic 11-342 ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
08/06/2013 Materials 8-339 ASTM F1091-12 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
12/21/2020 Materials 8-541 ASTM F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
08/06/2013 Materials 8-342 ASTM F1537-11 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
12/21/2020 Nanotechnology 18-18 ASTM E3247-20 Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
06/07/2018 ObGyn/
Gastroenterology/
Urology		 9-116 ISO 29943-2 First edition 2017-07 Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports.
06/07/2018 Dental/
ENT		 4-241 ANSI ADA Standard No. 80-2001 (R2020) Dental Materials-Determination of Color Stability
ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability
09/17/2018 Biocompatibility 2-255 ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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
12/21/2020 Anesthesiology 1-147 ISO 26825 Second edition 2020-10 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
05/27/2005 Radiology 12-121 IEC 61847: 1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0
01/14/2019 Cardiovascular 3-66 ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
01/14/2019 Sterility 14-518 ANSI AAMI ST55:2016 Table-top steam sterilizers
11/08/2005 InVitro Diagnostics 7-113 CLSI I/LA23-A (Replaces I/LA23-P) Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
09/09/2008 Software/
Informatics		 13-22 CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
03/16/2012 InVitro Diagnostics 7-150 CLSI H43-A2 Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
08/06/2013 Software/
Informatics		 13-57 IEEE ISO 11073-10407 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
01/27/2015 Sterility 14-389 ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
01/27/2015 Sterility 14-390 ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
08/21/2017 General II (ES/
EMC)		 19-22 AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
08/06/2013 Software/
Informatics		 13-40 ANSI AAMI IEC TIR 80001-2-1 2012 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
IEC TR 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
08/06/2013 Software/
Informatics		 13-44 ANSI AAMI IEC TIR 80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
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
 
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