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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)
 
12/23/2019 Materials 8-521 Complete ASTM F2313-18 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
07/06/2020 Sterility 14-539 Complete ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
07/06/2020 Materials 8-529 Complete ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
07/15/2019 Tissue Engineering 15-57 Complete ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
07/15/2019 Tissue Engineering 15-58 Complete ASTM F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
01/30/2014 General Plastic Surgery/
General Hospital		 6-321 Complete IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
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
09/17/2018 Ophthalmic 10-57 Complete ANSI Z80.13-2007 (R2022) American National Standard for Ophthalmics - Phakic Intraocular Lenses
09/17/2018 Ophthalmic 10-111 Complete ISO 11981 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
09/17/2018 Sterility 14-293 Complete ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
08/21/2017 Orthopedic 11-280 Complete ASTM F2624-12 (Reapproved 2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-111 Complete ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms - Requirements and test methods
12/18/2023 Sterility 14-592 Complete ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products - Part 1: General requirements
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-145 Complete ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
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
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-146 Complete ISO 8600-4 Third Edition 2023-01 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
07/09/2014 ObGyn/
Gastroenterology/
Urology		 9-94 Complete ISO 8600-4 Second Edition 2014-03-15 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
04/04/2016 Ophthalmic 10-100 Complete ISO 18259 First Edition 2014-10-01 Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
01/14/2019 Orthopedic 11-346 Complete ASTM F2706-18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
12/04/2017 Software/
Informatics		 13-101 Complete ISO IEC 15459-6 Second edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
04/04/2016 Materials 8-114 Complete ASTM F2255-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading
08/21/2017 Materials 8-195 Complete ASTM F2024-10 (Reapproved 2016) Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
08/21/2017 Materials 8-428 Complete ASTM F1581-08 (Reapproved 2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
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
08/21/2017 Orthopedic 11-242 Complete ASTM F1839-08 (Reapproved 2016) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
06/27/2016 Materials 8-426 Complete ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
06/27/2016 Materials 8-430 Complete ISO 13356:2015 Third Edition 2015-09-15 Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
06/27/2016 Materials 8-432 Complete ISO ASTM 52921 First Edition 2013-06-01 Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.
06/27/2016 Materials 8-434 Complete ISO ASTM 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology
07/09/2014 Anesthesiology 1-100 Complete CGA V-1:2013 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
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
07/09/2014 General II (ES/
EMC)		 19-10 Complete UL 1642 5th Edition Lithium Batteries
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
08/14/2015 Sterility 14-464 Complete ISO ASTM 51649 Third edition 2015-03-15 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
08/14/2015 Sterility 14-465 Complete ISO ASTM 51707 Third edition 2015-03-15 Guide for estimating uncertainties in dosimetry for radiation processing
04/04/2016 Materials 8-400 Complete ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
12/18/2023 Anesthesiology 1-162 Complete ISO 10651-4 Second edition 2023-03 Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
09/11/2023 Orthopedic 11-401 Complete ISO 21535 Third edition 2023-07 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
09/17/2018 Orthopedic 11-336 Complete ISO 17853 Third edition 2011-03-01 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
04/04/2016 Materials 8-413 Complete ASTM F2819-10 (Reapproved 2015) Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
05/29/2023 General Plastic Surgery/
General Hospital		 6-488 Complete ASTM F1671/F1671M-22 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
08/14/2015 Orthopedic 11-183 Complete ASTM F1875-98 (Reapproved 2022) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
12/23/2016 Orthopedic 11-319 Complete ISO 7206-12 First edition 2016-10-01 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
05/29/2023 Nanotechnology 18-23 Complete ASTM E3025-22 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
07/06/2020 Nanotechnology 18-15 Complete ASTM E3025-16 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
05/29/2023 Anesthesiology 1-161 Complete ISO 16628 Second edition 2022-06 Anaesthetic and respiratory equipment - Tracheobronchial tubes
08/21/2017 Anesthesiology 1-127 Complete ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking
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
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)]
04/04/2016 Materials 8-403 Complete ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
 
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