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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
01/14/2019 Software/
Informatics		 13-106 Complete IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
06/27/2016 Software/
Informatics		 13-84 Complete ISO IEEE 11073-10103 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
08/14/2015 InVitro Diagnostics 7-257 Complete CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
01/27/2015 Materials 8-383 Complete ASTM F1926/F1926M-14 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
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
12/20/2021 Materials 8-574 Complete ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
12/20/2021 Materials 8-575 Complete ASTM F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
12/20/2021 Materials 8-576 Complete ASTM F451-21 Standard Specification for Acrylic Bone Cement
07/06/2020 Sterility 14-549 Complete ASTM F3004-13 (Reapproved 2020) Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
07/15/2019 Sterility 14-528 Complete 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)]
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)]
12/23/2019 General I (QS/
RM)		 5-125 Complete ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
07/15/2019 Materials 8-503 Complete ASTM F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication
07/15/2019 Materials 8-509 Complete ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
12/19/2022 Sterility 14-580 Complete ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
12/20/2021 Cardiovascular 3-178 Complete ASTM F3067-14 (Reapproved 2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
12/20/2021 Dental/
ENT		 4-292 Complete ISO 28888 First edition 2013-10 Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
ANSI ADA Standard No. 151-2015 (R2020) Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
12/23/2019 Physical Medicine 16-228 Complete RESNA ANSI WC-4:2017 Section 19 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles.
07/15/2019 Materials 8-504 Complete ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-126 Complete ISO CIE 11664-3 First edition 2019-06 Colorimetry - Part 3: CIE tristimulus values
07/06/2020 Cardiovascular 3-167 Complete ISO TS 81060-5 First edition 2020-02 Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
12/23/2019 Radiology 12-328 Complete IEC 61223-3-5 Edition 2.0 2019-09 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
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
01/14/2019 General I (QS/
RM)		 5-122 Complete ASME V&V 40-2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices
01/14/2019 Dental/
ENT		 4-163 Complete ANSI ASA S3.5-1997 (Reaffirmed 2020) American National Standard Methods for Calculation of the Speech Intelligibility Index
07/06/2020 InVitro Diagnostics 7-298 Complete CLSI EP35, 1st Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
01/14/2019 Ophthalmic 10-114 Complete ANSI Z80.28-2017 American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
01/14/2019 Ophthalmic 10-115 Complete ANSI Z80.29-2015 (R2020) American National Standard for Ophthalmics - Accomodative Intraocular Lenses
07/06/2020 Biocompatibility 2-275 Complete ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
12/21/2020 General II (ES/
EMC)		 19-37 Complete IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
06/07/2021 Dental/
ENT		 4-277 Complete ANSI IEEE C63.19-2019 American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
07/15/2019 Orthopedic 11-356 Complete ISO 15142-2 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
08/06/2013 Dental/
ENT		 4-204 Complete ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
12/23/2016 Software/
Informatics		 13-87 Complete ISO IEC 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
12/20/2021 Dental/
ENT		 4-291 Complete ISO 28399 First edition 2011-01 Dentistry - Products for external tooth bleaching
ANSI ADA Standard No. 136-2015 (R2020) Products for External Tooth Bleaching
12/20/2021 Sterility 14-565 Complete USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/23/2019 Software/
Informatics		 13-111 Complete IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
06/07/2021 Orthopedic 11-376 Complete ASTM F2033-20 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
08/21/2017 Software/
Informatics		 13-96 Complete UL ANSI 2900-1 First Edition 2017 Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
12/21/2020 Nanotechnology 18-18 Complete ASTM E3247-20 Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
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
01/27/2015 Sterility 14-390 Complete ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
12/23/2019 Dental/
ENT		 4-262 Complete IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
12/23/2019 Materials 8-498 Complete ASTM F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
12/23/2019 Materials 8-499 Complete ASTM F1580-18 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
12/23/2019 Materials 8-500 Complete ISO 5832-12 Third edition 2019-02 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
07/06/2020 Materials 8-536 Complete ISO ASTM 52902:First Edition 2019-07 Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
12/21/2020 Dental/
ENT		 4-264 Complete ISO 9333 Second edition 2006-07 Dentistry - Brazing materials
ANSI ADA Standard No. 88-2019 Dental Brazing Alloys
07/06/2020 Materials 8-532 Complete 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 Complete ISO ASTM 52907: First Edition 2019-11 Additive Manufacturing - Feedstock materials - Methods to characterize metal powders
07/06/2020 Tissue Engineering 15-59 Complete ASTM F2450-18 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
 
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