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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
05/30/2022 Cardiovascular 3-181 ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
12/20/2021 Dental/
ENT		 4-287 ANSI ADA Standard No. 116-2020 Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
12/20/2021 InVitro Diagnostics 7-309 ISO 17099 First edition 2014-11-15 Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
12/20/2021 Dental/
ENT		 4-288 ANSI ADA Standard No. 43-2020 Electrically Powered Dental Amalgamators
ISO 7488 Second edition 2018-04 Dentistry - Mixing machines for dental amalgam
01/27/2015 Software/
Informatics		 13-72 IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
07/09/2014 InVitro Diagnostics 7-213 CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
07/09/2014 Radiology 12-282 ISO 12609-1 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
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
08/21/2017 Software/
Informatics		 13-90 IEEE Std 11073-10417-2015 Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
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
12/19/2022 Software/
Informatics		 13-126 AAMI ANSI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle
12/19/2022 Software/
Informatics		 13-127 AAMI ANSI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle
12/19/2022 Software/
Informatics		 13-121 AAMI ANSI UL 2800-1:2022 Standard for Medical Device Interoperability
12/20/2021 Cardiovascular 3-180 ASTM F3505 - 21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
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
12/19/2022 Orthopedic 11-397 ASTM F3210-22e1 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
12/19/2022 General I (QS/
RM)		 5-135 ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices - Information to be supplied by the manufacturer
12/19/2022 General I (QS/
RM)		 5-138 AAMI TIR66: 2017/(R)2020 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
12/19/2022 General I (QS/
RM)		 5-139 ISO 18250-3 First edition 2018-06 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
12/20/2021 General II (ES/
EMC)		 19-41 ANSI UL 61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
09/17/2018 Materials 8-478 ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
08/21/2017 Sterility 14-501 ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
09/17/2018 Materials 8-472 ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
08/06/2013 General Plastic Surgery/
General Hospital		 6-179 ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods
07/15/2019 Software/
Informatics		 13-109 AAMI ANSI UL 2800-1:2019 Standard for Safety for Medical Device Interoperability
12/20/2021 Cardiovascular 3-173 ISO 5840-3 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
08/06/2013 General Plastic Surgery/
General Hospital		 6-275 ISO 11608-2 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
08/06/2013 General Plastic Surgery/
General Hospital		 6-294 ISO 11608-3 Second edition 2012-10-01 Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
01/14/2019 Dental/
ENT		 4-254 ANSI ADA Standard No. 99-2001 (R2013) Athletic Mouth Protectors and Materials
05/30/2022 General Plastic Surgery/
General Hospital		 6-480 ISO 11608-6:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
05/30/2022 General Plastic Surgery/
General Hospital		 6-481 ANSI AAMI CN27:2021 General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
05/30/2022 General Plastic Surgery/
General Hospital		 6-482 AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
09/17/2018 Tissue Engineering 15-55 ASTM F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
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
01/14/2019 Cardiovascular 3-79 ASTM F2079-09 (Reapproved 2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
05/30/2022 Materials 8-589 ASTM F1925-22 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
12/20/2021 Materials 8-573 ASTM F2695-12(2020) Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
09/17/2018 Orthopedic 11-335 ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles
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 Orthopedic 11-357 ISO 15142-3 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments
06/07/2018 Anesthesiology 1-132 ISO 10079-2 Third Edition 2014-05-01 Medical suction equipment - Part 2: Manually powered suction equipment
12/19/2022 Anesthesiology 1-156 ISO 10079-3 Fourth edition 2022-03 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
06/07/2018 Anesthesiology 1-133 ISO 10079-3 Third Edition 2014-05-01 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
01/14/2019 InVitro Diagnostics 7-285 CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
07/06/2020 InVitro Diagnostics 7-297 ISO /TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
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
12/19/2022 General I (QS/
RM)		 5-137 IEC /TR 60878 Ed. 4.0 2022-11 Graphical symbols for electrical equipment in medical practice
08/06/2013 Cardiovascular 3-116 ANSI AAMI ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
ISO 25539-2 Second edition 2012-12-01 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
12/20/2021 Cardiovascular 3-172 AAMI TIR42:2021 Evaluation of Particulates Associated with Vascular Medical Devices
12/19/2022 Materials 8-594 ISO 5832-6 Third Edition 2022-03 Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
12/20/2021 Materials 8-574 ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
12/20/2021 Materials 8-575 ASTM F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
12/20/2021 Materials 8-576 ASTM F451-21 Standard Specification for Acrylic Bone Cement
12/20/2021 General Plastic Surgery/
General Hospital		 6-465 USP-NF M76090_03_01 Sodium Chloride Irrigation
12/20/2021 General Plastic Surgery/
General Hospital		 6-466 USP-NF M76070_03_01 Sodium Chloride Injection
12/20/2021 General Plastic Surgery/
General Hospital		 6-467 USP-NF M80200_04_01 Nonabsorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital		 6-468 USP-NF M99670_02_01 <881> Tensile Strength
12/20/2021 General Plastic Surgery/
General Hospital		 6-469 USP-NF M99650_02_01 <861> Sutures - Diameter
12/20/2021 General Plastic Surgery/
General Hospital		 6-470 USP-NF M99660_03_01 <871> Sutures - Needle Attachment
12/20/2021 General Plastic Surgery/
General Hospital		 6-472 USP-NF M36660_04_01 Heparin Lock Flush Solution
12/20/2021 General Plastic Surgery/
General Hospital		 6-473 USP-NF M80190_04_01 Absorbable Surgical Suture
12/20/2021 Orthopedic 11-387 ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
12/19/2007 Ophthalmic 10-37 ISO 10942 Second edition 2006-06-01 Ophthalmic instruments - Direct ophthalmoscopes
12/19/2022 Ophthalmic 10-133 ISO 11979-10 Second edition 2018-03 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes.
12/20/2021 Cardiovascular 3-177 ASTM F2606 - 08 (Reapproved 2021) Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
12/20/2021 Materials 8-578 ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
12/20/2021 Materials 8-579 ISO 13779-3 Second Edition 2018-12 Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
05/30/2022 Sterility 14-577 ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
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.
12/20/2021 Cardiovascular 3-176 ISO 18193 First edition 2021-08 Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
12/19/2022 Orthopedic 11-396 ISO 7206-13 First edition 2016-07-01 [Including AMD1:2022] Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
12/19/2022 Orthopedic 11-398 ASTM F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices
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
01/14/2019 Materials 8-489 ASTM F3302-18 Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion
01/14/2019 Cardiovascular 3-44 ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
12/23/2019 Physical Medicine 16-222 ANSI RESNA WC-1:2019 Section 20 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs
01/14/2019 General II (ES/
EMC)		 19-34 IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)]
12/20/2021 Dental/
ENT		 4-292 ANSI ADA Standard No. 151-2015 (R2020) Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
ISO 28888 First edition 2013-10 Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
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
09/09/2008 InVitro Diagnostics 7-136 CLSI I/LA2-A2 (Replaces I/LA2-A) Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition.
09/09/2008 InVitro Diagnostics 7-159 CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
09/09/2008 InVitro Diagnostics 7-163 CLSI H56-A (Replaces H56-P) Body Fluid Analysis for Cellular Composition; Approved Guideline.
04/04/2016 Dental/
ENT		 4-222 ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants
12/20/2021 Dental/
ENT		 4-286 ANSI ADA Standard No. 87-1995 (R2014) Dental Impression Trays
12/23/2016 Biocompatibility 2-189 ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-68 ISO 23409 First edition 2011-02-15 Male Condoms - Requirements and test methods for condoms made from synthetic materials
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-111 ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms - Requirements and test methods
08/06/2013 Materials 8-342 ASTM F1537-11 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
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)
12/20/2021 General II (ES/
EMC)		 19-44 ANSI IEEE C63.24-2021 American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems
12/20/2021 General I (QS/
RM)		 5-134 ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
12/19/2022 Software/
Informatics		 13-122 IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
12/19/2022 Software/
Informatics		 13-124 AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
08/06/2013 Radiology 12-211 IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
08/06/2013 Software/
Informatics		 13-37 CLSI AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
08/06/2013 Dental/
ENT		 4-167 ANSI ASA S3.21-2004 (Reaffirmed 2019) American National Standard Methods for Manual Pure-Tone Threshold Audiometry
 
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