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U.S. Department of Health and Human Services

Recognized Consensus Standards

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07/15/2019 Ophthalmic 10-117 ANSI Z80.37-2017 (R2021) American National Standard for Ophthalmics - Slit-Lamp Microscopes
07/15/2019 InVitro Diagnostics 7-287 CLSI M44-S3 (2018) Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
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
01/14/2019 Orthopedic 11-343 ASTM F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
12/23/2019 Materials 8-524 ASTM F3276-19 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
07/15/2019 InVitro Diagnostics 7-288 CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
01/14/2019 InVitro Diagnostics 7-286 CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
07/06/2020 Orthopedic 11-363 ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
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)
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
08/21/2017 Dental/
ENT
4-232 ISO 20795-1 Second edition 2013-03-01 Dentistry - Base polymers - Part 1: Denture base polymers
08/06/2013 Software/
Informatics
13-42 ANSI AAMI IEC TIR 80001-2-2:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC TR 80001-2-2 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
01/14/2019 Software/
Informatics
13-79 ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
07/15/2019 Biocompatibility 2-264 ASTM F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
01/14/2019 Dental/
ENT
4-163 ANSI ASA S3.5-1997 (Reaffirmed 2020) American National Standard Methods for Calculation of the Speech Intelligibility Index
01/14/2019 Cardiovascular 3-138 ASTM F2942-13 Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
03/31/2006 Radiology 12-137 ISO 4090 Third eidition 2001-08-15 Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications
09/09/2008 Sterility 14-142 ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
10/04/2010 Radiology 12-215 IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
03/16/2012 Tissue Engineering 15-31 ASTM F2312-11 (Reapproved 2020) Standard Terminology Relating to Tissue Engineered Medical Products
08/06/2013 Software/
Informatics
13-53 IEEE ISO 11073-10415 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
12/04/2017 Software/
Informatics
13-101 IEC ISO 15459-6 Second edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
01/14/2019 Biocompatibility 2-136 ASTM E1262-88 (Reapproved 2018) Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
07/06/2020 Dental/
ENT
4-263 ISO 9693 Third edition 2019-10 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
07/09/2014 Software/
Informatics
13-15 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
06/27/2016 Dental/
ENT
4-228 ANSI ASA S3.20-2015 (Reaffirmed 2020) American National Standard Bioacoustical Terminology
08/14/2015 InVitro Diagnostics 7-252 CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
06/07/2018 Materials 8-113 ASTM F1147-05 (Reapproved 2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
01/14/2019 Biocompatibility 2-145 ASTM F1439-03 (Reapproved 2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential 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
07/09/2014 Sterility 14-433 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
01/27/2015 Orthopedic 11-281 ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis
08/14/2015 Software/
Informatics
13-74 IEEE Std 11073-10424-2014 Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
01/27/2015 Sterility 14-141 ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
06/15/2016 General I (QS/
RM)
5-102 IEC 60417:2002 DB Graphical symbols for use on equipment
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
07/06/2020 Software/
Informatics
13-113 IEEE Std 11073-20601-2019 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol.
07/06/2020 General Plastic Surgery/
General Hospital
6-439 ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
01/14/2014 Radiology 12-268 IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
04/04/2016 Materials 8-135 ASTM F2392-04 (Reapproved 2015) Standard Test Method for Burst Strength of Surgical Sealants
01/27/2015 Materials 8-383 ASTM F1926/F1926M-14 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
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
07/15/2019 Anesthesiology 1-143 ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
03/16/2012 Anesthesiology 1-62 ANSI AAMI ISO 5356-1:2004 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
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
08/06/2013 General Plastic Surgery/
General Hospital
6-179 ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods
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
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
01/14/2019 Neurology 17-14 ANSI AAMI NS4:2013(R)2017 Transcutaneous Electrical Nerve Stimulators
06/07/2018 Materials 8-464 ISO /TS 10974 Second edition 2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
04/04/2016 Sterility 14-333 ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
07/26/2016 Biocompatibility 2-213 ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
01/14/2019 Physical Medicine 16-204 ISO 7176-6 Third edition 2018-06 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
07/06/2020 General Plastic Surgery/
General Hospital
6-441 ISO 7886-3 Second edition 2020-05 Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
09/17/2018 Materials 8-474 ASTM F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
09/17/2018 Materials 8-475 ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
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 Materials 8-519 ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
01/14/2019 Radiology 12-102 ANSI IES RP-27.2-00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
09/17/2018 InVitro Diagnostics 7-275 CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry.
09/17/2018 InVitro Diagnostics 7-276 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
09/17/2018 Orthopedic 11-337 ISO 16087 First edition 2013-10-01 Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
09/17/2018 Orthopedic 11-339 ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
01/30/2014 Dental/
ENT
4-181 ISO 4049 Fourth edition 2009-10-01 Dentistry - Polymer-based restorative materials
07/06/2020 Orthopedic 11-369 ASTM F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
08/21/2017 General I (QS/
RM)
5-107 ANSI AAMI ISO 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
IEC 80369-5: Edition 1.0 2016-03 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)]
01/30/2014 Sterility 14-427 ANSI AAMI ISO 13408-1:2008 (R2011) Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
06/07/2018 Nanotechnology 18-10 ISO 29701 First edition 2010-09-15 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test.
07/15/2019 Orthopedic 11-349 ISO 14242-3 First edition 2009-03-15 Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]
12/21/2020 Materials 8-542 ASTM F138-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-131 ISO 8600-5 Second Edition 2020-10 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
09/17/2018 Orthopedic 11-335 ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles
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
07/15/2019 General Plastic Surgery/
General Hospital
6-422 AAMI TIR38:2019 Medical device safety assurance case guidance
07/06/2020 Sterility 14-543 ANSI AAMI ISO TIR 11139:2006 Sterilization of health care products - Vocabulary
ISO 11139 First edition 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
07/06/2020 Sterility 14-544 ISO 18472 Second edition 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment
07/15/2019 General Plastic Surgery/
General Hospital
6-421 ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
12/21/2020 Dental/
ENT
4-266 ANSI ADA Standard No. 178-2019 Orthodontic Anchor Screws
ISO 19023 First edition 2018-02 Dentistry - Orthodontic anchor screws
09/17/2018 Orthopedic 11-322 ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
09/17/2018 Materials 8-467 ASTM F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
09/17/2018 Materials 8-468 ASTM F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
01/14/2019 Dental/
ENT
4-162 ANSI ASA S3.4-2007 (Reaffirmed 2017) American National Standard Procedure for the Computation of Loudness of Steady Sounds
06/07/2018 Anesthesiology 1-135 ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
06/07/2018 Anesthesiology 1-136 ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
07/09/2014 Software/
Informatics
13-68 ISO 11073-90101 First edition 2008-01-15 Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test
04/04/2016 Software/
Informatics
13-81 IEEE Std 11073-10419:2015 Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
07/15/2019 Materials 8-510 ASTM F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
09/17/2018 General Plastic Surgery/
General Hospital
6-409 ASTM F703-18 Standard Specification for Implantable Breast Prostheses
09/17/2018 Sterility 14-512 ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
09/17/2018 Sterility 14-275 ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
09/17/2018 Dental/
ENT
4-242 ANSI ADA Standard No. 75-2020 Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials
ISO 10139-1 Third edition 2018-03 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
01/14/2019 Orthopedic 11-272 ASTM F1714-96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
01/30/2014 Sterility 14-403 ASTM F2054/F2054M-13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
08/14/2015 Orthopedic 11-183 ASTM F1875-98 (Reapproved 2014) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
 
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