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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
08/14/2015 General Plastic Surgery/
General Hospital		 6-353 ASTM F2051-00 (Reapproved 2014) Standard Specification for Implantable Saline Filled Breast Prosthesis
12/04/2017 Software/
Informatics		 13-99 IEC ISO 15459-2 Third edition 2015-03-01 Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
07/09/2014 Software/
Informatics		 13-65 ANSI UL 1998 Third Edition 2013 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
07/26/2016 Biocompatibility 2-227 ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
01/14/2019 Dental/
ENT		 4-248 ISO 10477 Third edition 2018-06 Dentistry - Polymer-based crown and veneering materials
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)]
07/09/2014 Orthopedic 11-277 ISO 7206-6 Second edition 2013-11-15 Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
07/09/2014 Tissue Engineering 15-40 ASTM F2211-13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
06/07/2018 Radiology 12-315 NEMA MS 8-2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
08/14/2015 General Plastic Surgery/
General Hospital		 6-200 ASTM E1061-01 (Reapproved 2014) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
08/21/2017 Materials 8-428 ASTM F1581-08 (Reapproved 2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
08/21/2017 Materials 8-452 ASTM F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
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)]
12/23/2016 Orthopedic 11-314 ISO 14242-2 Second edition 2016-09-15 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
09/09/2008 Software/
Informatics		 13-23 CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
09/09/2008 Software/
Informatics		 13-24 CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
05/05/2010 InVitro Diagnostics 7-205 CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
05/05/2010 InVitro Diagnostics 7-207 CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - Third Edition
10/04/2010 Radiology 12-215 IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
03/14/2011 Radiology 12-217 IEC 62083 Edition 2.0 2009-09 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
10/04/2010 InVitro Diagnostics 7-212 CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
08/14/2015 Ophthalmic 10-94 ISO 14730 Second edition 2014-10-01 Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
08/21/2017 Sterility 14-502 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
06/07/2018 Sterility 14-510 ANSI AAMI ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11137-3 Second edition 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
07/15/2019 Tissue Engineering 15-57 ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
08/14/2015 Ophthalmic 10-95 ISO 11979-6 Third edition 2014-10-01 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
08/06/2013 Orthopedic 11-252 ISO 5838-1 Third edition 2013-03-01 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
09/21/2016 InVitro Diagnostics 7-266 CLSI EP19 2nd Edition (Replaces EP19-R) A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
04/04/2016 Physical Medicine 16-195 ISO 7176-1 Third edition 2014-10-01 Wheelchairs - Part 1: Determination of static stability
06/07/2018 Ophthalmic 10-107 ISO 18369-4 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
03/16/2012 Ophthalmic 10-70 ISO 10943 Third edition 2011-08-15 Ophthalmic instruments - Indirect ophthalmoscopes
03/16/2012 Radiology 12-106 ISO 17526 First edition 2003-06-15 Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers
03/16/2012 Radiology 12-246 ISO 21254-2 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination
03/16/2012 Radiology 12-245 ISO 21254-1 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles
08/20/2012 General Plastic Surgery/
General Hospital		 6-242 ISO 8536-2 Third edition 2010-03-15 Infusion equipment for medical use - Part 2: Closures for infusion bottles
01/15/2013 Sterility 14-359 ASTM F2096-11 (Reapproved 2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
03/16/2012 General Plastic Surgery/
General Hospital		 6-269 ASTM F1078-10 (Reapproved 2018) Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades
08/21/2017 General I (QS/
RM)		 5-107 ANSI AAMI ISO 80369-5 : 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.
IEC 80369-5: Edition 1.0 2016-03 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)]
01/30/2014 Sterility 14-427 ANSI AAMI ISO 13408-1:2008 (R2011) Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
04/04/2016 Sterility 14-409 ANSI AAMI ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-2 Third edition 2013-06-01 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
06/07/2018 Nanotechnology 18-10 ISO 29701 First edition 2010-09-15 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test.
01/14/2019 Radiology 12-321 ANSI IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
04/04/2016 Radiology 12-188 NEMA MS-1-2008 (R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
04/04/2016 Radiology 12-187 NEMA MS 3-2008 (R2020) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
12/23/2016 Materials 8-440 ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
08/21/2017 Dental/
ENT		 4-215 ANSI ADA Standard No. 96-2012 Dental Water-based Cements
08/21/2017 Materials 8-226 ASTM F603-12 (Reapproved 2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
08/06/2013 Software/
Informatics		 13-60 IEC /TS 62443-1-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
08/06/2013 Software/
Informatics		 13-62 IEC /TR 62443-3-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
01/30/2014 Dental/
ENT		 4-199 ISO 6876 Third edition 2012-06-01 Dentistry -- Root canal sealing materials
01/30/2014 Physical Medicine 16-27 ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
01/30/2014 Cardiovascular 3-54 ANSI AAMI ISO 7198:2016 Second edition Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches
01/30/2014 Physical Medicine 16-163 ISO 7176-5 Second edition 2008-06-01 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
08/06/2013 General Plastic Surgery/
General Hospital		 6-295 ANSI AAMI BF7:2012 Blood transfusion microfilters
09/17/2018 Orthopedic 11-333 ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
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
12/23/2019 Materials 8-498 ASTM F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
12/21/2020 ObGyn/
Gastroenterology/
Urology		 9-130 ISO 8600-6 Second edition 2020-09 Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
12/21/2020 Materials 8-542 ASTM F138-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
09/17/2018 Orthopedic 11-326 ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
09/17/2018 Orthopedic 11-327 ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
09/17/2018 Orthopedic 11-329 ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables
08/06/2013 Dental/
ENT		 4-90 ANSI ASA S3.39:1987 (Reaffirmed 2020) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
08/06/2013 Cardiovascular 3-87 ASTM F2477-07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability
06/27/2016 Materials 8-429 ASTM F2224-09 (Reapproved 2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
01/30/2014 General Plastic Surgery/
General Hospital		 6-117 ASTM F2172-02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
01/30/2014 General Plastic Surgery/
General Hospital		 6-303 ISO 10555-5 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters
01/14/2019 Dental/
ENT		 4-256 ANSI ADA Standard No. 132-2015 Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
12/21/2020 Biocompatibility 2-278 ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
08/21/2017 Software/
Informatics		 13-96 ANSI UL 2900-1 First Edition 2017 Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
08/14/2015 Software/
Informatics		 13-77 IEC ISO 29147 First edition 2014-02-15 Information technology - Security techniques - Vulnerability disclosure
01/30/2014 Materials 8-123 ISO 5832-5 Third edition 2005-10-15 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
01/14/2019 Anesthesiology 1-114 ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
12/20/2021 Materials 8-570 ASTM F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
01/30/2014 Dental/
ENT		 4-181 ISO 4049 Fourth edition 2009-10-01 Dentistry - Polymer-based restorative materials
01/27/2015 Dental/
ENT		 4-136 ASTM F2504-05 (Reapproved 2014) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
07/09/2014 Dental/
ENT		 4-149 ANSI ADA Standard No. 39-2006 (R2011) Pit and Fissure Sealants
06/07/2018 Anesthesiology 1-136 ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
09/17/2018 Orthopedic 11-340 ASTM F3018-17 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
08/21/2017 General II (ES/
EMC)		 19-29 ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
12/04/2017 Software/
Informatics		 13-100 IEC ISO 15459-4 Third edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages
03/16/2012 Sterility 14-332 ANSI AAMI ISO 11140-5:2007/(R)2012 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
ISO 11140-5 Second edition 2007-03-15 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
03/16/2012 Anesthesiology 1-62 ANSI AAMI ISO 5356-1:2004 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
09/17/2018 InVitro Diagnostics 7-283 CLSI POCT04 3rd Edition Essential Tools for Implementation and Management of a Point-of-Care Testing Program
05/30/2022 Materials 8-588 ASTM F560-22 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
01/30/2014 Orthopedic 11-75 ISO 5838-3 First edition 1993-09-15 Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
01/30/2014 Orthopedic 11-83 ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-86 ISO 16037 First edition 2002-05-15 (Amendment 1 2011-02-15) Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)]
01/30/2014 Radiology 12-259 IEC 61674 Edition 2.0 2012-11 Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
06/27/2016 Software/
Informatics		 13-82 AAMI ISO /TIR 80001-2-6:2014 Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
06/27/2016 Software/
Informatics		 13-83 AAMI TIR57:2016 Principles for medical device security - Risk management.
09/17/2018 Sterility 14-513 ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
01/30/2014 Materials 8-358 ASTM F1855-00 (Reapproved 2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
04/04/2016 General Plastic Surgery/
General Hospital		 6-356 ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
06/07/2021 Dental/
ENT		 4-279 ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
01/30/2014 Ophthalmic 10-87 ASTM D882-12 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
04/04/2016 Sterility 14-340 ANSI AAMI ISO 20857:2010/(R)2015 (Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 20857 First edition 2010-08-15 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
09/09/2008 Sterility 14-239 ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
06/07/2018 Anesthesiology 1-132 ISO 10079-2 Third Edition 2014-05-01 Medical suction equipment - Part 2: Manually powered suction equipment
06/07/2018 Neurology 17-15 ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
 
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