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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
01/14/2019 General Plastic Surgery/
General Hospital		 6-410 ISO 8536-6 Third edition 2016-12-01 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
03/31/2006 Radiology 12-138 ISO 5799 Second edition 1991-08-01 Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient
10/04/2004 Radiology 12-116 ISO 13696:2002 Optics and optical instruments -- Test methods for radiation scattered by optical components
01/30/2014 General I (QS/
RM)		 5-47 ISO 10012 First edition 2003-01-15 Measurement management systems - Requirements for measurement processes and measuring equipment
11/08/2005 InVitro Diagnostics 7-113 CLSI I/LA23-A (Replaces I/LA23-P) Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
12/19/2007 Ophthalmic 10-39 ISO 12865 Second edition 2006-07-01 Ophthalmic instruments - Retinoscopes
12/19/2007 Radiology 12-171 ISO 14880-2:2006 Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
12/19/2007 Radiology 12-172 ISO 14880-3:2006 Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations
12/20/2021 Orthopedic 11-388 ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
03/16/2012 Radiology 12-113 ISO 12005 Second edition 2003-04-01 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
09/17/2018 Orthopedic 11-329 ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables
09/17/2018 Orthopedic 11-185 ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
09/17/2018 Orthopedic 11-197 ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
09/17/2018 Orthopedic 11-199 ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
12/19/2007 Radiology 12-173 ISO 14880-4:2006 Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
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
03/16/2012 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
01/15/2013 Software/
Informatics		 13-33 AAMI TIR 36:2007 Validation of software for regulated processes
08/06/2013 InVitro Diagnostics 7-242 CLSI C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
08/14/2015 Software/
Informatics		 13-78 IEC INCITS ISO 30111 First edition 2013-11-01 (R2019) Information technology - Security techniques - Vulnerability handling processes
12/20/2021 Radiology 12-342 NEMA PS 3.1 - 3.20 2021e Digital Imaging and Communications in Medicine (DICOM) Set
09/17/2018 Materials 8-476 ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
09/17/2018 Materials 8-479 ISO 13781 Second edition 2017-07 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
09/17/2018 Orthopedic 11-324 ASTM F366-17 Standard Specification for Fixation Pins and Wires
09/17/2018 Orthopedic 11-325 ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
06/07/2018 Radiology 12-315 NEMA MS 8-2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
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
03/18/2009 InVitro Diagnostics 7-145 CLSI H42-A2 (Replaces H42-A) Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
09/09/2008 Radiology 12-165 NEMA XR 22-2006 (R2020) "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
09/09/2008 Software/
Informatics		 13-9 CLSI AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification
12/19/2022 Nanotechnology 18-22 ISO 17200 First edition 2020-09 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
12/20/2021 Materials 8-571 ASTM F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
12/19/2022 Anesthesiology 1-158 ISO 10079-4 First edition 2021-08 Medical suction equipment - Part 4: General requirements
01/27/2015 Orthopedic 11-283 ASTM F2943-14 (Reapproved 2019) Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
12/23/2016 Sterility 14-500 ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
07/15/2019 Orthopedic 11-352 ISO 14242-1 Third edition 2014-10-15 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
12/20/2021 Orthopedic 11-393 ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
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
08/20/2012 Software/
Informatics		 13-31 CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
08/20/2012 Cardiovascular 3-102 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
08/20/2012 Cardiovascular 3-104 ASTM F2914-12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
12/20/2021 Materials 8-567 ASTM F86-21 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)
12/19/2022 Anesthesiology 1-153 NFPA 99:2021 Health Care Facilities Code
03/31/2006 Anesthesiology 1-67 NFPA 99:2005 Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities
01/30/2014 Anesthesiology 1-78 ASME PVHO-1-2007 Safety Standard for Pressure Vessels for Human Occupancy
12/20/2021 Orthopedic 11-390 ISO 23089-2 First edition 2021-05 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
12/20/2021 Orthopedic 11-385 ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
01/15/2013 General Plastic Surgery/
General Hospital		 6-122 ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
03/16/2012 InVitro Diagnostics 7-227 CLSI M53-A (Replaces M53-P) Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
01/15/2013 InVitro Diagnostics 7-233 CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
01/15/2013 InVitro Diagnostics 7-235 CLSI EP25-A (Replaces EP25-P) Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
01/15/2013 InVitro Diagnostics 7-237 CLSI MM01-A3 (Replaces MM01-A2) Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition
01/15/2013 InVitro Diagnostics 7-238 CLSI MM06-A2 (Replaces MM06-A) Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
04/04/2016 Dental/
ENT		 4-221 ISO 7494-2 Second edition 2015-04-01 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
12/19/2022 Anesthesiology 1-154 ASME PVHO-1-2019 Safety Standard for Pressure Vessels for Human Occupancy
12/20/2021 Materials 8-580 IEC 63145-20-10 Edition 1.0 2019-08 Eyewear display -- Part 20-10: Fundamental measurement methods -- Optical properties
12/20/2021 Materials 8-581 IEC 63145-20-20 Edition 1.0 2019-09 Eyewear display -- Part 20-20: Fundamental measurement methods -- Image quality
08/06/2013 Tissue Engineering 15-14 ASTM F2603-06 (Reapproved 2020) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
01/15/2013 Sterility 14-212 AOAC 6.2.02:2006 Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
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
06/15/2016 General I (QS/
RM)		 5-104 IEC /TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice
12/23/2016 Biocompatibility 2-93 ASTM F763-04 (Reapproved 2016) Standard Practice for Short-Term Screening of Implant Materials
12/19/2022 Biocompatibility 2-289 ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
04/04/2016 Materials 8-116 ASTM F2258-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
04/04/2016 Materials 8-200 ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
01/30/2014 Sterility 14-401 ASTM F2217/F2217M-13 (Reapproved 2018) Standard Practice for Coating/Adhesive Weight Determination
01/14/2019 Materials 8-482 ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
12/20/2021 Materials 8-582 IEC 63145-22-10 Edition 1.0 2020-01 Eyewear display -- Part 22-10: Specific measurement methods for AR type -- Optical properties
09/09/2008 Software/
Informatics		 13-10 CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
08/20/2012 General Plastic Surgery/
General Hospital		 6-278 ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
01/15/2013 Software/
Informatics		 13-36 AAMI TIR 45:2012 Guidance on the use of AGILE practices in the development of medical device software
09/21/2016 Ophthalmic 10-101 ISO 18189 First edition 2016-06-01 Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
12/23/2019 Materials 8-520 ASTM F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
07/06/2020 Materials 8-528 ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
09/17/2018 Ophthalmic 10-112 ISO 11986 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
09/17/2018 Anesthesiology 1-140 ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
09/17/2018 General Plastic Surgery/
General Hospital		 6-123 ASTM E667-98 (Reapproved 2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
08/14/2015 Nanotechnology 18-4 ISO TS 80004-6 First edition 2013-11-01 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
08/20/2012 InVitro Diagnostics 7-76 CLSI M15-A (Replaces M15-T) Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
08/20/2012 Radiology 12-249 IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems
08/20/2012 Anesthesiology 1-87 IEC 60601-2-23 Edition 3.0 2011-02 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
08/20/2012 InVitro Diagnostics 7-197 CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
03/16/2012 Anesthesiology 1-73 ANSI AAMI ISO 10651-4:2002 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators
ISO 10651-4 First edition 2002-03-01 Lung ventilators - Part 4: Particular requirements for operator powered resuscitators
07/09/2014 Dental/
ENT		 4-177 ANSI ASA S12.65-2006 (Reaffirmed 2020) American National Standard For Rating Noise with Respect to Speech Interference
12/19/2022 General Plastic Surgery/
General Hospital		 6-484 ASTM F3502-22a Standard Specification for Barrier Face Coverings
09/17/2018 Dental/
ENT		 4-246 ANSI ADA Standard No. 144-2018 Alloy for Dental Amalgam
ISO 20749 First edition 2017-03 Dentistry - Pre-capsulated dental amalgam
12/21/2020 Dental/
ENT		 4-265 ANSI ADA Standard No. 97-2020 Corrosion Test Methods for Metallic Materials
ISO 10271 Third edition 2020-08 Dentistry - Corrosion test methods for metallic materials
07/06/2020 InVitro Diagnostics 7-297 ISO /TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
03/16/2012 InVitro Diagnostics 7-150 CLSI H43-A2 Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
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
06/27/2016 Sterility 14-483 ASTM ISO 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
04/04/2016 Tissue Engineering 15-43 ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
01/30/2014 Dental/
ENT		 4-198 ANSI ADA Standard No.30-2013 (R2018) Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol Cements
ISO 3107 Fourth edition 2011-03-01 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
12/19/2022 General Plastic Surgery/
General Hospital		 6-485 ISO 7886-4 Second Edition 2018-11 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
 
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