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U.S. Department of Health and Human Services

Recognized Consensus Standards
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06/27/2016 Materials 8-217 ASTM F620-11 (Reapproved 2015) Standard Specification Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
06/27/2016 Materials 8-421 ASTM F629-15 Standard Practice for Radiography of Cast Metallic Surgical Implants
06/27/2016 Materials 8-426 ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
06/27/2016 Materials 8-427 ASTM F1185-03 (Reapproved 2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants
06/27/2016 Materials 8-429 ASTM F2224-09 (Reapproved 2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
06/27/2016 Materials 8-430 ISO 13356:2015 Third Edition 2015-09-15 Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
06/27/2016 Materials 8-431 ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
06/27/2016 Materials 8-432 ASTM ISO 52921 First Edition 2013-06-01 Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.
06/27/2016 Materials 8-434 ASTM ISO 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology
06/27/2016 Orthopedic 11-306 ASTM F1814-15 Standard Guide for Evaluating Modular Hip and Knee Joint Components
06/27/2016 Orthopedic 11-307 ASTM F2385-15 (Reapproved 2019) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
06/27/2016 Orthopedic 11-308 ASTM F3161-16 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
06/27/2016 Radiology 12-293 IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
06/27/2016 Radiology 12-294 IEC 60601-2-45 Edition 3.1 2015 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
06/27/2016 Radiology 12-295 IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
06/27/2016 Radiology 12-297 ANSI IES RP-27.1-2015 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
06/27/2016 Radiology 12-298 NEMA MS 10-2010 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
06/27/2016 Radiology 12-301 IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
06/27/2016 Radiology 12-302 IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
06/27/2016 Software/
Informatics		 13-82 ANSI 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.
06/27/2016 Software/
Informatics		 13-84 IEEE ISO 11073-10103 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
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 14-482 ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
06/27/2016 Sterility 14-483 ASTM ISO 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
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
07/26/2016 Biocompatibility 2-170 ANSI AAMI ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
07/26/2016 Biocompatibility 2-174 ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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
07/26/2016 Biocompatibility 2-213 ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
07/26/2016 Biocompatibility 2-222 ANSI AAMI ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/26/2016 Biocompatibility 2-227 ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
07/26/2016 Biocompatibility 2-228 ANSI AAMI ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
07/26/2016 Biocompatibility 2-237 ANSI AAMI ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
07/26/2016 Biocompatibility 2-240 ANSI AAMI ISO TIR 10993-20:2006 Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO /TS 10993-20 First edition 2006-08-01 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
07/26/2016 Biocompatibility 2-241 ANSI AAMI ISO /TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO /TR 37137 First edition 2014-05-15 Cardiovascular biological evaluation of medical devices - Guidance for absorbable 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
09/21/2016 General Plastic Surgery/
General Hospital		 6-379 ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test methods
09/21/2016 General Plastic Surgery/
General Hospital		 6-380 ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
09/21/2016 General Plastic Surgery/
General Hospital		 6-381 ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
09/21/2016 General Plastic Surgery/
General Hospital		 6-382 ISO 11608-7 First edition 2016-08-01 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
09/21/2016 InVitro Diagnostics 7-265 CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
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
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
12/23/2016 Anesthesiology 1-118 ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/23/2016 Anesthesiology 1-119 ISO 14408 Third edition 2016-02-15 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
12/23/2016 Biocompatibility 2-93 ASTM F763-04 (Reapproved 2016) Standard Practice for Short-Term Screening of Implant Materials
12/23/2016 Biocompatibility 2-94 ASTM F981-04 (Reapproved 2016) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
12/23/2016 Biocompatibility 2-189 ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
12/23/2016 Biocompatibility 2-244 ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
12/23/2016 Biocompatibility 2-245 ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
12/23/2016 Cardiovascular 3-144 ISO 7198 Second edition 2016-08-01 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
12/23/2016 General I (QS/
RM)		 5-113 ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
12/23/2016 General I (QS/
RM)		 5-114 ANSI AAMI IEC Standard
IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
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
12/23/2016 InVitro Diagnostics 7-267 CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
12/23/2016 InVitro Diagnostics 7-268 CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
12/23/2016 Materials 8-368 ASTM F2625-10 (Reapproved 2016) Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
12/23/2016 Materials 8-435 ISO 5832-1 Fifth edition 2016-07-15 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
12/23/2016 Materials 8-437 ASTM F2082/F2082M-16 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
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 Materials 8-440 ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
12/23/2016 Materials 8-441 ASTM F3109-16 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
12/23/2016 Materials 8-442 ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
12/23/2016 Materials 8-444 ISO 17296-2 First edition 2015-01-15 Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock
12/23/2016 Orthopedic 11-311 ISO 14243-2 Third edition 2016-09-01 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
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
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
12/23/2016 Orthopedic 11-319 ISO 7206-12 First edition 2016-10-01 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
12/23/2016 Orthopedic 11-320 ISO 7206-13 First edition 2016-07-01 Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
12/23/2016 Physical Medicine 16-199 ISO 7176-28 First edition 2012-10-1 Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
12/23/2016 Radiology 12-303 IEC 61303 Edition 1.0 1994-09 Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)]
12/23/2016 Radiology 12-304 IEC 60731 Edition 3.1 2016-04 Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
12/23/2016 Software/
Informatics		 13-85 CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
12/23/2016 Software/
Informatics		 13-86 IEC ISO 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
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
12/23/2016 Sterility 14-169 ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
12/23/2016 Sterility 14-496 ASTM F1608-16 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
12/23/2016 Sterility 14-497 ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
12/23/2016 Sterility 14-499 ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
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
12/23/2016 Tissue Engineering 15-48 ASTM F2605-16 Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
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
08/21/2017 Anesthesiology 1-127 ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking
08/21/2017 Biocompatibility 2-155 ASTM F2147-01 (Reapproved 2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
08/21/2017 Biocompatibility 2-246 ASTM F1877-16 Standard Practice for Characterization of Particles
08/21/2017 Biocompatibility 2-247 ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
08/21/2017 Biocompatibility 2-248 ANSI AAMI ISO 10993-4: 2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
08/21/2017 Cardiovascular 3-149 ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
08/21/2017 Dental/
ENT		 4-215 ANSI ADA Standard No. 96-2012 Dental Water-based Cements
08/21/2017 Dental/
ENT		 4-231 ANSI ADA Standard No. 111-2019 Adhesion Test Methods to Tooth Structure
ISO /TS 11405 Third edition 2015-02-01 Dentistry - Testing of adhesion to tooth structure
08/21/2017 Dental/
ENT		 4-232 ISO 20795-1 Second edition 2013-03-01 Dentistry - Base polymers - Part 1: Denture base polymers
08/21/2017 Dental/
ENT		 4-233 ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers
08/21/2017 Dental/
ENT		 4-234 ANSI ADA Standard No. 139-2012 Dental Base Polymers
08/21/2017 Dental/
ENT		 4-236 ANSI ADA Standard No. 119-2015 Manual Toothbrushes
08/21/2017 Dental/
ENT		 4-238 ANSI ADA Standard No.120-2009 (R2014) Powered Toothbrushes
ISO 20127 First edition 2005-03-15 Dentistry - Powered toothbrushes - General requirements and test methods
08/21/2017 Dental/
ENT		 4-239 ANSI AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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)]
 
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