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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)
 
12/19/2022 Radiology 12-349 Complete NEMA PS 3.1 - 3.20 2022d Digital Imaging and Communications in Medicine (DICOM) Set
06/07/2018 Anesthesiology 1-136 Complete 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
06/07/2018 Tissue Engineering 15-54 Complete ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
08/14/2015 Physical Medicine 16-194 Complete ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
05/29/2023 Biocompatibility 2-300 Complete ISO 10993-2 Third edition 2022-11 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
09/17/2018 Dental/
ENT		 4-244 Complete ISO 8325 Second edition 2004-09-15 Dentistry - Test methods for rotary instruments
06/07/2018 Neurology 17-15 Complete ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
12/18/2023 Dental/
ENT		 4-316 Complete ISO 20127 Second edition 2020-08 Dentistry - Physical properties of powered toothbrushes
ANSI ADA Standard No.120-2022 Dentistry - Physical Properties of Powered Toothbrushes
08/21/2017 Dental/
ENT		 4-238 Complete ISO 20127 First edition 2005-03-15 Dentistry - Powered toothbrushes - General requirements and test methods
ANSI ADA Standard No.120-2009 (R2014) Powered Toothbrushes
12/18/2023 Dental/
ENT		 4-317 Complete ISO 8325 Third edition 2023-03 Dentistry - Test methods for rotary instruments
01/30/2014 Physical Medicine 16-165 Complete 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
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-124 Complete CIE ISO 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers
09/17/2018 General Plastic Surgery/
General Hospital		 6-409 Complete ASTM F703-18 Standard Specification for Implantable Breast Prostheses
09/17/2018 Sterility 14-512 Complete ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
09/17/2018 Sterility 14-275 Complete ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
09/17/2018 Dental/
ENT		 4-242 Complete ISO 10139-1 Third edition 2018-03 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
ANSI ADA Standard No. 75-2020 Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials
09/17/2018 Orthopedic 11-335 Complete ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles
08/21/2017 Materials 8-455 Complete ASTM F2902-16 Standard Guide for Assessment of Absorbable Polymeric Implants
08/21/2017 Orthopedic 11-321 Complete ASTM F2887-17 Standard Specification for Total Elbow Prostheses
12/18/2023 Orthopedic 11-405 Complete ASTM F1829-23 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
09/17/2018 Tissue Engineering 15-55 Complete ASTM F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
09/17/2018 Materials 8-468 Complete ASTM F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
01/25/2013 Cardiovascular 3-89 Complete ISO 27186 First edition 2010-03-15 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ANSI AAMI ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
08/20/2012 Cardiovascular 3-103 Complete ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
ANSI AAMI ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
12/19/2007 Radiology 12-171 Complete ISO 14880-2:2006 Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
03/18/2009 InVitro Diagnostics 7-145 Complete CLSI H42-A2 (Replaces H42-A) Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
03/16/2012 Radiology 12-175 Complete ISO 24013 First edition 2006-11-15 Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation
08/20/2012 InVitro Diagnostics 7-148 Complete CLSI M28-A2 (Replaces M28-A) Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition.
08/06/2013 Software/
Informatics		 13-52 Complete ISO IEEE 11073-10408 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
08/06/2013 General Plastic Surgery/
General Hospital		 6-216 Complete ISO 8536-7 Third edition 2009-01-15 Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles
08/21/2017 Orthopedic 11-309 Complete ASTM F116-12 (Reapproved 2016) Standard Specification for Medical Screwdriver Bits
05/29/2023 Physical Medicine 16-235 Complete ISO 7176-25 Second Edition 2022 Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods
05/29/2023 Physical Medicine 16-236 Complete ISO 7176-19 Third Edition 2022 Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles
09/17/2018 Materials 8-380 Complete ASTM F1160-14 (Reapproved 2017)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
09/17/2018 Materials 8-470 Complete ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
06/07/2018 Tissue Engineering 15-51 Complete ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
06/07/2018 Tissue Engineering 15-52 Complete ASTM F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
08/21/2017 Materials 8-449 Complete ASTM F1058-16 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
01/30/2014 Radiology 12-59 Complete IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
01/30/2014 Radiology 12-264 Complete NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
01/30/2014 Materials 8-159 Complete ISO 9584 First edition 1993-10-15 Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants
06/07/2018 Radiology 12-312 Complete IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
06/07/2018 Radiology 12-313 Complete IEC TS 62462 Edition 2.0 2017-07 Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems
01/30/2014 InVitro Diagnostics 7-239 Complete CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report
09/17/2018 Orthopedic 11-334 Complete ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
12/18/2023 Orthopedic 11-407 Complete ASTM F3140-23 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
08/21/2017 Sterility 14-502 Complete ISO 11138-1 Third edition 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements
ANSI AAMI ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
06/07/2018 General Plastic Surgery/
General Hospital		 6-407 Complete ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
06/15/2016 Cardiovascular 3-132 Complete ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
ANSI AAMI ISO 27185:2012 Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
12/23/2016 Materials 8-442 Complete ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
 
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