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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
09/08/2009 Software/
Informatics		 13-29 CLSI LIS01-A2 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
03/16/2012 Radiology 12-117 ISO 15367-1 First edition 2003-09-15 Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects
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 Orthopedic 11-290 ISO 8828 Second edition 2014-11-15 Implants for surgery -- Guidance on care and handling of orthopaedic implants
08/06/2013 Orthopedic 11-254 ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants -- General requirements
06/27/2016 Software/
Informatics		 13-83 AAMI TIR57:2016 Principles for medical device security - Risk management.
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
01/30/2014 Neurology 17-12 ISO 7197 Third edition 2006-06-01 Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
04/04/2016 Physical Medicine 16-197 ISO 7176-8 Second editon 2014-12-15 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
04/04/2016 Ophthalmic 10-73 ANSI Z80.21-2010 (R2015) American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
06/07/2018 General Plastic Surgery/
General Hospital		 6-401 ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
09/17/2018 InVitro Diagnostics 7-279 CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
08/14/2015 General Plastic Surgery/
General Hospital		 6-185 ASTM F881-94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants
09/17/2018 Materials 8-475 ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
09/17/2018 Materials 8-470 ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
09/17/2018 Radiology 12-202 IEC 60601-2-43 - Ed. 2.0 2010-03 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
07/15/2019 Sterility 14-531 ANSI AAMI ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
09/17/2018 Orthopedic 11-335 ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles
07/06/2020 Materials 8-529 ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
12/23/2019 General I (QS/
RM)		 5-124 ISO 7000 Sixth edition 2019-07 Graphical symbols for use on equipment - Registered symbols
06/07/2018 Biocompatibility 2-250 ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
09/17/2018 General II (ES/
EMC)		 19-19 IEC /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
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)]
07/06/2020 InVitro Diagnostics 7-297 ISO /TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
12/23/2016 Materials 8-439 ASTM F3001-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
12/23/2016 Orthopedic 11-312 ISO 7206-4 Third edition 2010-06-15 Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
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 Physical Medicine 16-230 ANSI RESNA WC-2:2019 Section 25 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs
01/14/2019 Materials 8-179 ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
12/23/2016 Biocompatibility 2-244 ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
12/21/2020 Materials 8-540 ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
04/04/2016 Dental/
ENT		 4-224 ISO 24234 Second edition 2015-05-01 Dentistry - Dental Amalgam
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
07/09/2014 Dental/
ENT		 4-92 ANSI ADA Standard No. 88 - 2000 (R2012) Dental Brazing Alloys
12/23/2019 Materials 8-491 ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
07/15/2019 Materials 8-495 ISO 5834-3 Second edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
01/15/2013 Software/
Informatics		 13-34 ANSI AAMI IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80002-1 Edition 1.0 2009-09 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
01/14/2019 Tissue Engineering 15-56 ASTM F3224-17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
01/30/2014 General Plastic Surgery/
General Hospital		 6-306 ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
12/21/2020 Nanotechnology 18-18 ASTM E3247-20 Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
07/26/2016 Biocompatibility 2-169 ANSI AAMI ISO 10993-13:2010/(R)2014 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
01/14/2019 Cardiovascular 3-86 ASTM F2394-07 (Reapproved 2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
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		 6-443 ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
07/06/2020 General Plastic Surgery/
General Hospital		 6-446 ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
07/09/2014 Materials 8-374 ASTM F2633-13 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
07/15/2019 Tissue Engineering 15-57 ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
07/15/2019 Tissue Engineering 15-58 ASTM F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
01/30/2014 Biocompatibility 2-205 ANSI AAMI ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
ISO 14155 Second edition 2011-02-01 Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
12/21/2020 Sterility 14-555 USP 43-NF38:2020 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
07/15/2019 Biocompatibility 2-263 ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
06/07/2021 Biocompatibility 2-289 ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/23/2019 Materials 8-508 ASTM F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
01/14/2019 Nanotechnology 18-7 ASTM E2834-12 (Reapproved 2018) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)
07/15/2019 InVitro Diagnostics 7-290 CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
07/06/2020 Nanotechnology 18-15 ASTM E3025-16 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
08/06/2013 Software/
Informatics		 13-55 IEEE Std 11073-10421-2010 Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
03/16/2012 Radiology 12-177 UL 122-2007 (R2011) Standard for Photographic Equipment - Ed. 5.0
08/06/2013 Software/
Informatics		 13-49 IEEE ISO 11073-20101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
09/09/2008 Radiology 12-166 NEMA XR 23-2006 (R2020) "Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-128 CIE ISO 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula
04/04/2016 Materials 8-411 ASTM F2579-10 Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
12/23/2019 Physical Medicine 16-226 ANSI RESNA 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.
12/21/2020 Sterility 14-553 ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
10/17/2014 ObGyn/
Gastroenterology/
Urology		 9-95 CEN EN 1615:2000 Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing
07/09/2014 General Plastic Surgery/
General Hospital		 6-180 ASTM F2407-06 (Reapproved 2013) Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
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
01/30/2014 Materials 8-361 ASTM F755-99 (Reapproved 2011) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
12/21/2020 Materials 8-546 ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
07/26/2016 Biocompatibility 2-243 ISO /TR 10993-33 First Edition 2015-03-01 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
01/14/2019 Cardiovascular 3-159 ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
01/14/2019 Sterility 14-314 ANSI AAMI ST67:2011/(R)2017 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
06/07/2021 Software/
Informatics		 13-118 IEEE Std 11073-40102:2020 Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation.
06/07/2021 Software/
Informatics		 13-119 ANSI ISA 62443-4-1-2018 Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements.
12/21/2020 Tissue Engineering 15-65 ISO 22442-2 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
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)
06/07/2021 Cardiovascular 3-168 IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
06/07/2021 Physical Medicine 16-231 ISO 10328 Second edition 2016-06-01 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
12/21/2020 General II (ES/
EMC)		 19-39 IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
07/15/2019 General Plastic Surgery/
General Hospital		 6-11 ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
12/21/2020 Biocompatibility 2-281 ISO /TS 10993-19 Second edition 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
12/21/2020 General Plastic Surgery/
General Hospital		 6-449 ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs
07/15/2019 Sterility 14-533 ISO /TS 19930 First edition 2017-12 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
08/21/2017 General Plastic Surgery/
General Hospital		 6-387 ANSI AAMI IEC 60601-2-50:2009/A1:2016 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
IEC 60601-2-50 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
06/07/2018 Sterility 14-511 ANSI AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
12/21/2020 Orthopedic 11-330 ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
07/26/2016 Biocompatibility 2-191 ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
04/04/2016 Anesthesiology 1-115 ISO 80601-2-70 First Edition 2015-01-15 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
12/21/2020 Orthopedic 11-375 ASTM F2193-20 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
06/07/2021 Materials 8-558 ASTM F3333-20 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
06/07/2021 Materials 8-555 ASTM F1472-20a Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
12/19/2007 Ophthalmic 10-35 ISO 10939 Second edition 2007-02-01 Ophthalmic instruments - Slit-lamp microscopes
12/23/2019 General Plastic Surgery/
General Hospital		 6-438 ANSI AAMI IEC 80601-2-77:2020 Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
IEC 80601-2-77 Edition 1.0 2019-07 Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
07/06/2020 Materials 8-526 ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance
08/06/2013 Dental/
ENT		 4-203 ANSI ASA S3.6-2010 American National Standard Specification for Audiometers
06/07/2021 Dental/
ENT		 4-274 ANSI ASA S3.2-2020 American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
06/07/2021 Dental/
ENT		 4-279 ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
06/07/2021 Dental/
ENT		 4-280 ANSI ADA Standard No. 117-2018 Fluoride varnishes
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		 4-282 ANSI ADA Standard No. 135-2015 Denture Adhesives
ISO 10873 First edition 2010-09 Dentistry - Denture adhesives
 
 
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