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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
07/09/2014 Dental/
ENT
4-211 ANSI ASA S3.46-2013 (Reaffirmed 2018) American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
01/30/2014 Sterility 14-403 ASTM F2054/F2054M-13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/30/2014 Sterility 14-430 ASTM ISO 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
01/14/2019 Materials 8-485 ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
04/04/2016 Dental/
ENT
4-190 ANSI ASA S3.35-2010 (Reaffirmed 2020) American National Standard Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
01/14/2019 Orthopedic 11-346 ASTM F2706-18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
07/09/2014 General II (ES/
EMC)
19-10 UL 1642 5th Edition Lithium Batteries
08/21/2017 Dental/
ENT
4-234 ANSI ADA Standard No. 139-2012 Dental Base Polymers
06/07/2018 Nanotechnology 18-9 ISO /TR 13014 First edition 2012-05-15 Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)].
06/07/2018 Dental/
ENT
4-240 ANSI ADA Standard No. 128-2015 Hydrocolloid Impression Materials
ISO 21563 First edition 2013-08-15 Dentistry - Hydrocolloid impression materials
01/30/2014 Dental/
ENT
4-151 ANSI ADA Standard No. 15-2008 (R2013) Artificial Teeth for Dental Prostheses
ISO 22112 First edition 2005-11-01 Dentistry - Artificial teeth for dental prostheses
09/17/2018 Orthopedic 11-310 ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers
09/17/2018 Orthopedic 11-334 ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
06/27/2016 Dental/
ENT
4-86 ANSI ADA Standard No. 38-2000 (R2015) Metal-Ceramic Dental Restorative Systems
12/23/2016 Software/
Informatics
13-87 IEC ISO 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
01/14/2019 Orthopedic 11-347 ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
12/04/2017 Software/
Informatics
13-102 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
04/04/2016 Tissue Engineering 15-24 ASTM F2721-09 (Reapproved 2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
12/23/2016 General II (ES/
EMC)
19-20 ANSI IEEE C63.16-2016 (Revision of ANSI C63.16-1993) American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
08/06/2013 Software/
Informatics
13-59 IEC ISO 15026-4 First edition 2012-10-01 Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle
06/07/2018 Anesthesiology 1-135 ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
07/06/2020 Software/
Informatics
13-113 IEEE Std 11073-20601-2019 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol.
07/06/2020 General Plastic Surgery/
General Hospital
6-439 ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
07/06/2020 General Plastic Surgery/
General Hospital
6-441 ISO 7886-3 Second edition 2020-05 Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
01/25/2013 Cardiovascular 3-89 ANSI AAMI ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
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
08/20/2012 Cardiovascular 3-103 ANSI AAMI ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
06/15/2016 Cardiovascular 3-132 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
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
04/04/2016 Cardiovascular 3-125 ANSI AAMI ISO 5841-3:2013 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 5841-3 Third edition 2013-04-15 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
06/07/2018 Tissue Engineering 15-54 ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
06/07/2018 Biocompatibility 2-250 ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
07/06/2020 General Plastic Surgery/
General Hospital
6-444 ASTM D7103-19 Standard Guide for Assessment of Medical Gloves
01/14/2019 Anesthesiology 1-141 ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
01/14/2019 Materials 8-482 ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
08/21/2017 General II (ES/
EMC)
19-25 IEC 62485-1 Edition 1.0 2015-04 Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
08/21/2017 General II (ES/
EMC)
19-27 IEC 62485-3 Edition 2.0 2014-07 Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
04/04/2016 Nanotechnology 18-1 ASTM E2490-09 (Reapproved 2015) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
09/17/2018 Sterility 14-512 ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
09/17/2018 Sterility 14-275 ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
09/17/2018 Dental/
ENT
4-242 ANSI ADA Standard No. 75-2020 Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials
ISO 10139-1 Third edition 2018-03 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
09/17/2018 Cardiovascular 3-110 AAMI TIR 41:2011/(R)2017 Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-119 IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-67 ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
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
09/17/2018 General Plastic Surgery/
General Hospital
6-409 ASTM F703-18 Standard Specification for Implantable Breast Prostheses
09/17/2018 Sterility 14-293 ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
04/04/2016 Materials 8-413 ASTM F2819-10 (Reapproved 2015) Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
09/17/2018 Sterility 14-516 ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
09/17/2018 General I (QS/
RM)
5-119 ISO 18250-3 First edition 2018-06 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
09/17/2018 Radiology 12-318 IEC 60601-2-64 Edition 1.0 2014-09 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
09/17/2018 Radiology 12-320 IEC 62667 Edition 1.0 2017-08 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
07/09/2014 Materials 8-379 ISO 11542-2 First edition 1998-11-15 Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
08/21/2017 Orthopedic 11-280 ASTM F2624-12 (Reapproved 2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
08/21/2017 Orthopedic 11-321 ASTM F2887-17 Standard Specification for Total Elbow Prostheses
12/23/2019 Physical Medicine 16-220 ANSI RESNA WC-1:2019 Section 15 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling
07/06/2020 Radiology 12-333 IEC TR 63183 Edition 1.0 2019-12 Guidance on error and warning messages for software used in radiotherapy
07/09/2014 Radiology 12-275 IEC 61161 Edition 3.0 2013-01 Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
07/09/2014 Radiology 12-281 IEC 60601-2-62 Edition 1.0 2013-07 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
07/09/2014 Radiology 12-283 ISO 12609-2 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use
04/04/2016 Orthopedic 11-299 ASTM F2068-15 Standard Specification for Femoral Prostheses - Metallic Implants
04/04/2016 Orthopedic 11-303 ASTM F3047M-15 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
12/20/2021 Cardiovascular 3-172 AAMI TIR42:2021 Evaluation of Particulates Associated with Vascular Medical Devices
06/27/2015 Sterility 14-484 ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
08/21/2017 Orthopedic 11-269 ASTM F2423-11 (Reapproved 2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
07/09/2014 Materials 8-378 ASTM D792-13 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
12/23/2016 Orthopedic 11-316 ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
12/23/2016 Orthopedic 11-317 ASTM F3129-16 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
08/21/2017 Anesthesiology 1-124 ISO 8835-7 First edition 2011-11-01 Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
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
12/23/2019 Physical Medicine 16-221 ANSI RESNA WC-1:2019 Section 16 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods
04/04/2016 Materials 8-107 ASTM F746-04 (Reapproved 2014) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
04/04/2016 Materials 8-115 ASTM F2256-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
04/04/2016 Materials 8-136 ASTM F2458-05 (Reapproved 2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
06/27/2016 General Plastic Surgery/
General Hospital
6-363 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 8-153 ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
08/06/2013 Materials 8-158 ASTM F1713-08 (Reapproved 2013) Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130)
04/04/2016 Orthopedic 11-301 ASTM F2091-15 Standard Specification for Acetabular Prostheses
08/14/2015 Sterility 14-464 ASTM ISO 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 ASTM ISO 51707 Third edition 2015-03-15 Guide for estimating uncertainties in dosimetry for radiation processing
04/04/2016 Materials 8-400 ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
12/21/2020 Orthopedic 11-373 ASTM F1223-20 Standard Test Method for Determination of Total Knee Replacement Constraint
12/21/2020 Orthopedic 11-370 ISO 14879-1 Second edition 2020-07 Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
04/04/2016 Orthopedic 11-247 ASTM F2789-10 (Reapproved 2020) Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
04/04/2016 General Plastic Surgery/
General Hospital
6-357 ISO 10555-6 First edition 2015-04-15 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports
08/14/2015 General Plastic Surgery/
General Hospital
6-185 ASTM F881-94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants
11/08/2005 Radiology 12-6 IEC 60806 First edition 1984-01 Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis
12/19/2007 Ophthalmic 10-37 ISO 10942 Second edition 2006-06-01 Ophthalmic instruments - Direct ophthalmoscopes
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
12/19/2007 Radiology 12-173 ISO 14880-4:2006 Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
12/19/2007 Radiology 12-176 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 CLSI C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline
03/18/2009 InVitro Diagnostics 7-176 CLSI I/LA30-A (Replaces I/LA30-P) Immunoassay Interference by Endogenous Antibodies; Approved Guideline.
03/14/2011 Radiology 12-221 IEC 61223-3-4 First edition 2000-03 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
03/16/2012 Dental/
ENT
4-173 ANSI ASA S3.44-1996 (Reaffirmed 2006) American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
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
08/06/2013 InVitro Diagnostics 7-242 CLSI C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
01/30/2014 General Plastic Surgery/
General Hospital
6-253 ISO 10535 Second edition 2006-12-15 Hoists for the transfer of disabled persons - Requirements and test methods
 
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