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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
05/29/2024 Materials 8-613 Complete ASTM F2527-24 Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants
12/22/2025 InVitro Diagnostics 7-347 Complete CLSI EP21 3rd Edition Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
05/26/2025 General Plastic Surgery/
General Hospital		 6-508 Complete IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
12/22/2025 Software/
Informatics		 13-151 Complete ISO IEEE 11073-10421 Second Edition 2024-08 Health informatics - Device Interoperability - Part 10421: Personal health device communication - Device specialization - Peak expiratory flow monitor (peak flow)
IEEE Std 11073-10421-2023 Health Informatics-Device Interoperability - Part 10421: Personal Health Device Communication - Device Specialization - Peak expiratory flow monitor (peak flow)
12/22/2025 Software/
Informatics		 13-152 Complete ISO TS 5615:2025 Health informatics - Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics
12/22/2025 Software/
Informatics		 13-156 Complete ISO IEEE 11073-10471 Second Edition 2024-09 Health Informatics - Device Interoperability - Part 10471: Personal Health Device Communication - Device Specialization-Independent Living Activity Hub
IEEE Std 11073-10471-2023 Health Informatics - Device interoperability - Part 10471: Personal health device communication - Device specialization - Independent living activity hub
12/23/2024 General II (ES/
EMC)		 19-52 Complete UL 2054 Third Edition November 17, 2021 Standard For Safety Household and Commercial Batteries
12/23/2024 General II (ES/
EMC)		 19-53 Complete IEC TS 60601-4-6 Edition 1.0 2024-04 Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
12/23/2024 Orthopedic 11-419 Complete ASTM F3690-24 Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance
12/22/2025 Orthopedic 11-438 Complete ASTM F2502-24 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
05/29/2023 General Plastic Surgery/
General Hospital		 6-486 Complete ISO 10535 Third edition 2021-10 Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
12/18/2023 Dental/
ENT		 4-321 Complete ISO 23450 First edition 2021-03 Dentistry - Intraoral camera
12/18/2023 Dental/
ENT		 4-322 Complete ISO 18675 First edition 2022-05 Dentistry - Machinable ceramic blanks
12/18/2023 Dental/
ENT		 4-323 Complete ISO 5139 First edition 2023-05 Dentistry - Polymer-based composite machinable blanks
12/18/2023 Dental/
ENT		 4-324 Complete ISO TS 16506 First edition 2017-07 Corrected version 2018-03 Dentistry - Polymer-based luting materials containing adhesive components
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
12/22/2025 Materials 8-630 Complete ASTM F90-24 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
08/21/2017 Materials 8-455 Complete ASTM F2902-16 Standard Guide for Assessment of Absorbable Polymeric Implants
05/29/2023 Biocompatibility 2-300 Complete ISO 10993-2 Third edition 2022-11 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
12/18/2023 Dental/
ENT		 4-318 Complete ISO 20749 Second edition 2023-06 Dentistry - Pre-capsulated dental amalgam
12/23/2024 Anesthesiology 1-187 Complete ISO 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
09/17/2018 Orthopedic 11-185 Complete ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
12/18/2023 Sterility 14-596 Complete ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials
12/18/2023 Sterility 14-597 Complete AAMI ANSI ST108:2023 Water for the processing of medical devices
05/29/2023 Physical Medicine 16-234 Complete ISO 7176-14 Third Edition 2022 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
12/22/2025 Anesthesiology 1-197 Complete ISO 17510 Second Edition 2025-11 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
12/23/2024 InVitro Diagnostics 7-322 Complete CLSI M47 2nd Edition Principles and Procedures for Blood Cultures
01/27/2015 Sterility 14-379 Complete ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
09/17/2018 Materials 8-412 Complete ASTM F2537-06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
07/06/2020 Anesthesiology 1-146 Complete ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
08/21/2017 Materials 8-451 Complete ASTM F2214-16 Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
12/18/2023 Materials 8-609 Complete ASTM F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
06/07/2021 Anesthesiology 1-151 Complete ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
01/30/2014 Sterility 14-427 Complete ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
12/18/2023 Sterility 14-593 Complete ASTM F3039-23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
06/07/2021 General II (ES/
EMC)		 19-40 Complete IEC 60086-4 Edition 5.0 2019-04 Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
09/17/2018 Orthopedic 11-326 Complete ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
12/18/2023 Dental/
ENT		 4-314 Complete ISO 7494-2 Third edition 2022-07 Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
01/14/2019 Materials 8-483 Complete ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
12/18/2023 InVitro Diagnostics 7-318 Complete CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
05/26/2025 Anesthesiology 1-193 Complete ISO 18190 Second edition 2025-02 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
01/14/2019 Anesthesiology 1-120 Complete ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
12/22/2025 Orthopedic 11-434 Complete ASTM F3018-25 Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement
05/29/2023 Sterility 14-585 Complete AAMI ISO TIR16775:2023 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO TS 16775 Second edition 2021-11 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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
09/09/2008 Sterility 14-142 Complete ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
03/18/2009 InVitro Diagnostics 7-170 Complete CLSI I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition
03/18/2009 InVitro Diagnostics 7-176 Complete CLSI I/LA30-A (Replaces I/LA30-P) Immunoassay Interference by Endogenous Antibodies; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-180 Complete CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-182 Complete CLSI M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-185 Complete CLSI M41-A Viral Culture; Approved Guideline.
03/18/2009 General Plastic Surgery/
General Hospital		 6-215 Complete ASTM F2132-01 (Reapproved 2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
03/18/2009 InVitro Diagnostics 7-190 Complete CLSI M50-A (Replaces M50-P) Quality Control for Commercial Microbial Identification Systems; Approved Guideline
05/29/2023 General Plastic Surgery/
General Hospital		 6-494 Complete ASTM F3352/F3352M-23a Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
12/22/2025 Orthopedic 11-423 Complete ASTM F2267-24 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
01/14/2019 Anesthesiology 1-138 Complete ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
12/23/2024 Anesthesiology 1-192 Complete ISO 23371 First edition 2022-05 Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices
07/09/2014 Sterility 14-282 Complete ASTM F2338-09 (Reapproved 2020) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
01/27/2015 ObGyn/
Gastroenterology/
Urology		 9-45 Complete ASTM F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
07/09/2014 Sterility 14-286 Complete ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
01/15/2013 Sterility 14-215 Complete AOAC 6.2.05:2006 Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
01/30/2014 Sterility 14-404 Complete ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
05/26/2025 Anesthesiology 1-194 Complete ISO 27427 Fourth edition 2023-07 Anaesthetic and respiratory equipment - Nebulizing systems and components
05/26/2025 Anesthesiology 1-195 Complete ISO 80369-2 First edition 2024-09 Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
05/29/2024 Software/
Informatics		 13-138 Complete ISO IEEE 11073-10700 First Edition 2024-09 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
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
05/29/2023 General Plastic Surgery/
General Hospital		 6-492 Complete ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks
01/15/2013 Sterility 14-217 Complete AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
03/16/2012 Anesthesiology 1-72 Complete ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
08/06/2013 Ophthalmic 10-78 Complete ISO 11979-3 Third edition 2012-12-01 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
12/23/2019 General II (ES/
EMC)		 19-13 Complete IEC 62133 Edition 2.0 2012-12 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 [Including: Corrigendum 1 (2013)]
08/21/2017 Radiology 12-306 Complete NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications
01/14/2019 Cardiovascular 3-66 Complete ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
12/22/2025 Biocompatibility 2-308 Complete ASTM F1984-25 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
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
09/17/2018 Orthopedic 11-329 Complete ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables
05/29/2024 Software/
Informatics		 13-134 Complete ISO IEEE 11073-10404 Second edition 2022-12 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
IEEE Std 11073-10404-2020 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
06/27/2016 Materials 8-427 Complete ASTM F1185-03 (Reapproved 2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants
12/23/2016 Physical Medicine 16-199 Complete ISO 7176-28 First edition 2012-10-1 Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
08/21/2017 Materials 8-458 Complete ASTM G5-14 Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
07/06/2020 Sterility 14-542 Complete ISO ASTM 52628 Second edition 2020-04 Standard practice for dosimetry in radiation processing
01/14/2019 Radiology 12-324 Complete ISO 13694 Third edition 2018-11 Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution
05/26/2025 Anesthesiology 1-196 Complete ISO 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
10/09/2023 Software/
Informatics		 13-131 Complete ANSI AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers
01/30/2014 Sterility 14-405 Complete ASTM F2252/F2252M-13 (Reapproved 2018) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
01/30/2014 Sterility 14-406 Complete ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
08/14/2015 Ophthalmic 10-99 Complete ISO 4311 First edition 1979-06-01 Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring
08/14/2015 Software/
Informatics		 13-75 Complete ISO IEEE 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
06/27/2016 Sterility 14-483 Complete ISO ASTM 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
06/07/2021 Orthopedic 11-384 Complete ASTM F3446-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
12/22/2025 Orthopedic 11-426 Complete ASTM F2943-25 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
09/17/2018 Orthopedic 11-325 Complete ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
01/30/2014 Dental/
ENT		 4-153 Complete ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
12/18/2023 Cardiovascular 3-189 Complete ASTM F2942-19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
12/18/2023 Cardiovascular 3-190 Complete ISO PAS 7020 First edition 2023-05 Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
05/29/2024 Radiology 12-356 Complete IEC 60601-2-22 Edition 4.0 2019-11 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
06/27/2016 Dental/
ENT		 4-228 Complete ANSI ASA S3.20-2015 (Reaffirmed 2025) American National Standard Bioacoustical Terminology
06/27/2016 Dental/
ENT		 4-202 Complete ANSI ADA Standard No. 58-2010 (R2015) Root Canal Files, Type H (Hedstrom)
01/30/2014 Physical Medicine 16-167 Complete ISO 7176-9 Third edition 2009-11-15 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
01/30/2014 Radiology 12-262 Complete ISO 11670 Second edition 2003-04-01 Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)]
 
 
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