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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/19/2007 Radiology 12-172 Complete ISO 14880-3:2006 Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations
12/19/2007 Radiology 12-173 Complete ISO 14880-4:2006 Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
12/19/2007 Radiology 12-176 Complete IEC 61223-3-2 Second eidtion 2007-07 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
09/09/2008 InVitro Diagnostics 7-21 Complete CLSI C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline
09/09/2008 InVitro Diagnostics 7-136 Complete CLSI I/LA2-A2 (Replaces I/LA2-A) Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition.
09/09/2008 InVitro Diagnostics 7-159 Complete CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
06/07/2021 Radiology 12-335 Complete IEC 60336 Edition 5.0 2020-12 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
03/16/2012 Radiology 12-174 Complete ISO 13697 First edition 2006-05-15 Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components
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
03/16/2012 Radiology 12-232 Complete NEMA MS 4-2010 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
03/16/2012 Radiology 12-242 Complete IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
08/20/2012 Software/
Informatics		 13-31 Complete CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
08/20/2012 Cardiovascular 3-102 Complete IEC 60601-2-31 Edition 2.1 2011-09 Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
10/04/2010 Radiology 12-214 Complete IEC 62220-1-3 Edition 1.0 2008-06 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
07/09/2014 Radiology 12-280 Complete IEC 62555 Edition 1.0 2013-11 Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
03/16/2012 Radiology 12-177 Complete UL 122-2007 (R2011) Standard for Photographic Equipment - Ed. 5.0
03/16/2012 Radiology 12-241 Complete IEC 62274 First Edition 2005-05 Medical electrical equipment - Safety of radiotherapy record and verify systems
08/06/2013 Radiology 12-253 Complete IEC 60976 Edition 2.0 2007-10 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
08/06/2013 Radiology 12-255 Complete IEC 60601-2-11 Edition 3.0 2013-01 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
08/21/2017 Sterility 14-502 Complete ANSI AAMI ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-1 Third edition 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements
12/04/2017 Software/
Informatics		 13-100 Complete ISO IEC 15459-4 Third edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages
09/17/2018 Materials 8-472 Complete ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
12/23/2016 InVitro Diagnostics 7-267 Complete CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
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
08/06/2013 Materials 8-338 Complete ASTM F139-12 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
12/21/2020 Materials 8-540 Complete ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
08/06/2013 Materials 8-339 Complete ASTM F1091-12 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
12/21/2020 Materials 8-541 Complete ASTM F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
08/06/2013 Materials 8-342 Complete ASTM F1537-11 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
07/15/2019 General II (ES/
EMC)		 19-35 Complete UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
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
12/23/2019 Physical Medicine 16-226 Complete RESNA ANSI WC-4:2017 Section 10 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transporation Section 10 Wheelchair and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers.
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
08/21/2017 Software/
Informatics		 13-93 Complete IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
08/21/2017 Dental/
ENT		 4-233 Complete ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers
08/21/2017 Sterility 14-501 Complete ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
01/30/2014 Materials 8-123 Complete ISO 5832-5 Third edition 2005-10-15 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
01/14/2019 Dental/
ENT		 4-254 Complete ANSI ADA Standard No. 99-2001 (R2013) Athletic Mouth Protectors and Materials
06/27/2016 Materials 8-429 Complete ASTM F2224-09 (Reapproved 2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
08/21/2017 Cardiovascular 3-149 Complete ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
07/15/2019 Materials 8-513 Complete ISO 20160 First edition 2006-05-01 Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
12/21/2020 InVitro Diagnostics 7-299 Complete CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
06/07/2021 Tissue Engineering 15-67 Complete ASTM F2212-20 Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
06/07/2018 Dental/
ENT		 4-241 Complete ANSI ADA Standard No. 80-2001 (R2020) Dental Materials-Determination of Color Stability
ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability
09/17/2018 Biocompatibility 2-255 Complete ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
12/21/2020 Dental/
ENT		 4-267 Complete ANSI ADA Standard No. 105-2010 (R2015) Orthodontic Elastomeric Materials
ISO 21606 First edition 2007-06 Dentistry - Elastomeric auxiliaries for use in orthodontics
06/07/2021 InVitro Diagnostics 7-306 Complete CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
07/15/2019 Orthopedic 11-353 Complete ISO 18192-3 First edition 2017-06 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
07/15/2019 Materials 8-514 Complete ISO 5834-2 Fifth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
 
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