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U.S. Department of Health and Human Services

Recognized Consensus Standards
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06/07/2021 InVitro Diagnostics 7-306 CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
12/21/2020 Anesthesiology 1-148 ISO 80601-2-69 Second edition 2020-11 Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
12/21/2020 Materials 8-546 ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
06/07/2021 Orthopedic 11-379 ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
06/07/2021 Orthopedic 11-380 ASTM F2979-20 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
12/21/2020 Sterility 14-551 ISO 14160 Third edition 2020-09 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
12/21/2020 Neurology 17-17 ASTM F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices
06/07/2021 General Plastic Surgery/
General Hospital		 6-461 IEC 60601-2-19 Edition 3.0 2020-09 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
06/07/2021 Tissue Engineering 15-67 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)
01/30/2014 InVitro Diagnostics 7-239 CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report
01/30/2014 InVitro Diagnostics 7-152 CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition.
08/21/2017 Materials 8-451 ASTM F2214-16 Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
01/30/2014 Sterility 14-404 ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
07/09/2014 InVitro Diagnostics 7-221 CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
07/09/2014 Radiology 12-272 IEC 60601-2-17 Edition 3.0 2013-11 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
01/30/2014 Radiology 12-266 IEC 61689 Edition 3.0 2013-02 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
08/14/2015 General Plastic Surgery/
General Hospital		 6-354 ASTM D7907-14 (Reapproved 2019) Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
08/14/2015 Materials 8-389 ISO 15309 First edition 2013-12-01 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
08/14/2015 Orthopedic 11-294 ASTM F1357 -14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants
08/14/2015 Radiology 12-292 IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
01/30/2014 Sterility 14-405 ASTM F2252/F2252M-13 (Reapproved 2018) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
01/30/2014 Sterility 14-406 ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
08/14/2015 Nanotechnology 18-4 ISO TS 80004-6 First edition 2013-11-01 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
08/14/2015 Ophthalmic 10-99 ISO 4311 First edition 1979-06-01 Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring
08/14/2015 Physical Medicine 16-194 ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
08/14/2015 Software/
Informatics		 13-75 IEEE ISO 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
08/14/2015 Software/
Informatics		 13-78 IEC ISO 30111 First edition 2013-11-01 Information technology - Security techniques - Vulnerability handling processes
04/04/2016 InVitro Diagnostics 7-260 CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
06/07/2021 General Plastic Surgery/
General Hospital		 6-462 IEC 60601-2-20 Edition 3.0 2020-09 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
07/15/2019 Materials 8-517 ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements
07/26/2016 Biocompatibility 2-124 ASTM F750-87 (Reapproved 2012) Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
06/07/2021 Dental/
ENT		 4-281 ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
06/07/2021 Dental/
ENT		 4-283 ANSI ADA Standard No. 125-2018 Manual Interdental Brushes
ISO 16409 Second edition 2016-10 Dentistry - Oral care products - Manual interdental brushes
06/07/2021 Anesthesiology 1-151 ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
07/26/2016 Biocompatibility 2-214 ASTM F619-14 Standard Practice for Extraction of Medical Plastics
12/21/2020 Biocompatibility 2-277 ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
06/07/2021 Materials 8-561 ASTM ISO 52950 First edition 2021-01 Additive manufacturing - General principles - Overview of data processing
05/30/2022 General II (ES/
EMC)		 19-46 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
05/30/2022 Anesthesiology 1-152 ISO 80601-2-87 First edition 2021-04 Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
12/20/2021 Cardiovascular 3-175 ISO 5840-2 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
05/30/2022 Sterility 14-576 ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
12/20/2021 Ophthalmic 10-129 ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
05/30/2022 Cardiovascular 3-181 ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
12/20/2021 Radiology 12-342 NEMA PS 3.1 - 3.20 2021e Digital Imaging and Communications in Medicine (DICOM) Set
05/30/2022 ObGyn/
Gastroenterology/
Urology		 9-139 CIE ISO 11664-5:2016 Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram
05/30/2022 General Plastic Surgery/
General Hospital		 6-478 ISO 11608-1:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
03/18/2009 InVitro Diagnostics 7-180 CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-182 CLSI M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-185 CLSI M41-A Viral Culture; Approved Guideline.
03/18/2009 General Plastic Surgery/
General Hospital		 6-215 ASTM F2132 -01 (Reapproved 2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
03/18/2009 InVitro Diagnostics 7-189 CLSI M47-A (Replaces M47-P) Principles and Procedures for Blood Cultures; Approved Guideline
03/18/2009 InVitro Diagnostics 7-190 CLSI M50-A (Replaces M50-P) Quality Control for Commercial Microbial Identification Systems; Approved Guideline
03/18/2009 InVitro Diagnostics 7-192 CLSI MM18-A (Replaces MM18-P) Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline
03/18/2009 InVitro Diagnostics 7-71 CLSI H15-A3 (Replaces H15-A2) Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
03/18/2009 Software/
Informatics		 13-25 CLSI AUTO8-A Managing and Validating Laboratory Information Systems; Approved Guideline
03/18/2009 Software/
Informatics		 13-26 CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
03/18/2009 Software/
Informatics		 13-28 CLSI AUTO9-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
12/20/2021 Physical Medicine 16-232 IEC 80601-2-78 Edition 1.0 2019-07 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
03/16/2012 Radiology 12-142 ISO 11146-2 First edition 2005-02-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
03/16/2012 Radiology 12-143 ISO 15367-2 First edition 2005-03-15 Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors
03/16/2012 Radiology 12-248 ISO 21254-3 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities
03/16/2012 Radiology 12-174 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 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 NEMA MS 4-2010 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
03/16/2012 Radiology 12-242 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
07/09/2014 Sterility 14-282 ASTM F2338-09 (Reapproved 2020) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
01/27/2015 Neurology 17-13 IEEE Std 2010-2012 Recommended Practice for Neurofeedback Systems
01/27/2015 ObGyn/
Gastroenterology/
Urology		 9-45 ASTM F2528-06 (Reapproved 2014) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
01/30/2014 Anesthesiology 1-97 CGA V-7.1:2011 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
07/09/2014 Sterility 14-286 ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
03/16/2012 General Plastic Surgery/
General Hospital		 6-177 ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
01/15/2013 Sterility 14-213 AOAC 6.2.03:2006 Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
01/15/2013 Sterility 14-215 AOAC 6.2.05:2006 Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
01/15/2013 Sterility 14-217 AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
03/16/2012 Anesthesiology 1-72 ANSI AAMI ISO 10651-5:2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
08/06/2013 Ophthalmic 10-78 ISO 11979-3 Third edition 2012-12-01 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
01/27/2015 Sterility 14-242 ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
08/06/2013 Radiology 12-205 IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
08/06/2013 Tissue Engineering 15-14 ASTM F2603-06 (Reapproved 2020) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
06/07/2018 Ophthalmic 10-109 ISO 18369-1 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
06/27/2016 Sterility 14-481 ISO 14644-2 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
08/06/2013 Sterility 14-381 ASTM ISO 51261 Second edition 2013-04-15 Practice for calibration of routine dosimetry systems for radiation processing
01/30/2014 Anesthesiology 1-81 CGA V-5:2008 (Reaffirmed 2013) Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
07/09/2014 Radiology 12-194 ANSI HPS N43.6-2007 (R2013) Sealed Radioactive Sources - Classification
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
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
12/20/2021 Materials 8-569 ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
05/30/2022 Materials 8-589 ASTM F1925-22 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
05/30/2022 Materials 8-592 ASTM F3384-21 Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
12/20/2021 Orthopedic 11-389 ISO 7206-10 Second edition 2018-08 Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
07/15/2019 Orthopedic 11-359 ISO 7206-10 Second edition 2018-08 Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
12/20/2021 Software/
Informatics		 13-120 ANSI AAMI 2700-1:2019 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
01/30/2014 Materials 8-346 ASTM F1813-13 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
12/20/2021 Materials 8-567 ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
01/30/2014 Materials 8-353 ASTM F86-13 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
12/20/2021 Materials 8-568 ASTM F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
03/16/2012 Tissue Engineering 15-31 ASTM F2312-11 (Reapproved 2020) Standard Terminology Relating to Tissue Engineered Medical Products
 
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