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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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07/26/2016 Biocompatibility 2-174 Complete ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
01/27/2015 Software/
Informatics
13-72 Complete IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
05/29/2023 Cardiovascular 3-186 Complete ISO 14708-2 Third edition 2019-09 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
05/29/2023 Cardiovascular 3-187 Complete ISO 14708-6 Second edition 2019-09 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
12/18/2023 InVitro Diagnostics 7-318 Complete CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
12/18/2023 Sterility 14-594 Complete ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
07/15/2019 Sterility 14-530 Complete ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ANSI AAMI ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
12/18/2023 Sterility 14-595 Complete ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)].
04/04/2016 Sterility 14-277 Complete ANSI AAMI ISO TIR 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1
ISO TS 17665-2 First edition 2009-01-15 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
04/04/2016 Sterility 14-333 Complete ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
08/06/2013 General Plastic Surgery/
General Hospital
6-296 Complete ANSI AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
12/19/2022 Orthopedic 11-397 Complete ASTM F3210-22e1 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
12/19/2022 Orthopedic 11-398 Complete ASTM F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices
12/20/2021 General II (ES/
EMC)
19-44 Complete IEEE ANSI 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 Complete 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
12/23/2016 Materials 8-441 Complete ASTM F3109-16 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
05/30/2022 Cardiovascular 3-182 Complete ASTM F3036-21 Standard Guide for Testing Absorbable Stents
04/04/2016 Dental/
ENT
4-190 Complete ANSI ASA S3.35-2010 (Reaffirmed 2020) American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
05/29/2023 Physical Medicine 16-235 Complete ISO 7176-25 Second Edition 2022 Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods
12/18/2023 Dental/
ENT
4-320 Complete ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
03/16/2012 Cardiovascular 3-96 Complete ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
ANSI AAMI ISO 81060-1:2007/(R)2013 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
07/12/1999 Radiology 12-51 Complete IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides
03/08/2004 InVitro Diagnostics 7-86 Complete CLSI C29-A2 (Replaces C29-A) Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition
03/08/2004 InVitro Diagnostics 7-87 Complete CLSI C31-A2 (Replaces C31-A) Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition.
03/08/2004 InVitro Diagnostics 7-88 Complete CLSI C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
03/08/2004 InVitro Diagnostics 7-89 Complete CLSI C39-A (Replaces C39-P) A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
10/04/2004 InVitro Diagnostics 7-105 Complete CLSI H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
05/29/2023 Materials 8-598 Complete ASTM F3109-22 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
01/30/2014 General Plastic Surgery/
General Hospital
6-253 Complete ISO 10535 Second edition 2006-12-15 Hoists for the transfer of disabled persons - Requirements and test methods
05/29/2023 General Plastic Surgery/
General Hospital
6-493 Complete ASTM F2101-23 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
12/23/2019 General Plastic Surgery/
General Hospital
6-427 Complete ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
12/19/2022 Ophthalmic 10-133 Complete 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.
12/19/2022 Software/
Informatics
13-126 Complete ANSI AAMI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle
12/19/2022 General I (QS/
RM)
5-141 Complete ASME V&V 20-2009 (R2021) Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
12/19/2022 Radiology 12-346 Complete ISO 12005 Third edition 2022-05 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
12/20/2021 InVitro Diagnostics 7-310 Complete ISO 19238 Second edition 2014-02-01 Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
12/20/2021 InVitro Diagnostics 7-311 Complete CLSI EP39, 1st Edition A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
12/19/2022 Software/
Informatics
13-127 Complete ANSI AAMI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle
12/19/2022 Software/
Informatics
13-121 Complete ANSI AAMI UL 2800-1:2022 Standard for Medical Device Interoperability
05/30/2022 ObGyn/
Gastroenterology/
Urology
9-139 Complete CIE ISO 11664-5:2016 Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram
05/29/2023 Physical Medicine 16-236 Complete ISO 7176-19 Third Edition 2022 Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles
07/26/2016 Biocompatibility 2-222 Complete ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
ANSI AAMI ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
12/19/2022 General Plastic Surgery/
General Hospital
6-483 Complete IEC 60601-2-35 Edition 2.0 2020-09 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
05/30/2022 Radiology 12-343 Complete IEC 62127-1 Edition 2.0 2022-03 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
01/30/2014 General Plastic Surgery/
General Hospital
6-321 Complete IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
05/30/2022 Materials 8-592 Complete ASTM F3384-21 Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
09/17/2018 Orthopedic 11-334 Complete ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
12/23/2016 Sterility 14-169 Complete ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
01/14/2019 ObGyn/
Gastroenterology/
Urology
9-121 Complete IEC 60601-2-16 Edition 5.0 2018-4 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
ANSI AAMI IEC 60601-2-16:2018 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
12/23/2019 General I (QS/
RM)
5-124 Complete ISO 7000 Sixth edition 2019-07 Graphical symbols for use on equipment - Registered symbols
12/23/2019 Radiology 12-328 Complete IEC 61223-3-5 Edition 2.0 2019-09 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
01/14/2019 Radiology 12-102 Complete ANSI IES RP-27.2-00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
08/21/2017 Cardiovascular 3-149 Complete ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
07/15/2019 Materials 8-513 Complete ISO 20160 First edition 2006-05-01 Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
07/15/2019 General II (ES/
EMC)
19-35 Complete UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
01/14/2019 Software/
Informatics
13-105 Complete ANSI AAMI SW91:2018 Classification of defects in health software
07/15/2019 Materials 8-517 Complete ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements
05/29/2023 Materials 8-604 Complete ASTM F2257-22 Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
06/07/2021 Orthopedic 11-381 Complete ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
01/14/2019 Dental/
ENT
4-162 Complete ANSI ASA S3.4-2007 (Reaffirmed 2020) American National Standard Procedure for the Computation of Loudness of Steady Sounds
07/06/2020 General I (QS/
RM)
5-129 Complete IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices
ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
12/21/2020 Ophthalmic 10-119 Complete ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
12/21/2020 General II (ES/
EMC)
19-39 Complete 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
ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] 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 [Including Amendment 1(2021)]
07/06/2020 Biocompatibility 2-273 Complete ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/15/2019 Materials 8-516 Complete ISO 13779-4 Second edition 2018-12 Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
12/20/2021 General Plastic Surgery/
General Hospital
6-465 Complete USP-NF M76090_03_01 Sodium Chloride Irrigation
12/20/2021 General Plastic Surgery/
General Hospital
6-466 Complete USP-NF M76070_03_01 Sodium Chloride Injection
12/20/2021 General Plastic Surgery/
General Hospital
6-467 Complete USP-NF M80200_04_01 Nonabsorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital
6-468 Complete USP-NF M99670_02_01 <881> Tensile Strength
12/20/2021 General Plastic Surgery/
General Hospital
6-469 Complete USP-NF M99650_02_01 <861> Sutures - Diameter
12/20/2021 General Plastic Surgery/
General Hospital
6-470 Complete USP-NF M99660_03_01 <871> Sutures - Needle Attachment
12/20/2021 General Plastic Surgery/
General Hospital
6-472 Complete USP-NF M36660_04_01 Heparin Lock Flush Solution
12/20/2021 General Plastic Surgery/
General Hospital
6-473 Complete USP-NF M80190_04_01 Absorbable Surgical Suture
12/20/2021 Orthopedic 11-387 Complete ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
05/29/2024 Sterility 14-600 Complete ASTM F1929-23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
06/27/2015 Sterility 14-484 Complete ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
12/20/2021 Materials 8-578 Complete ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
12/20/2021 Materials 8-579 Complete 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 Complete 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 Complete ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
05/29/2023 Sterility 14-585 Complete AAMI ISO TIR16775:2023 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO TS 16775 Second edition 2021-11 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
12/18/2023 Anesthesiology 1-163 Complete ISO 80601-2-72 Second edition 2023-06 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
07/15/2019 Sterility 14-532 Complete ASTM F3287-17e1 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
12/20/2021 Ophthalmic 10-129 Complete ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
06/07/2021 Dental/
ENT
4-281 Complete ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
ANSI ADA Standard No. 179-2020 Shanks for Rotary and Oscillating Instruments
07/15/2019 Anesthesiology 1-143 Complete ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
07/06/2020 Orthopedic 11-363 Complete ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
12/23/2019 Dental/
ENT
4-260 Complete ANSI ASA S12.2-2019 American National Standard for Criteria for Evaluating Room Noise
08/06/2013 Software/
Informatics
13-56 Complete IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph
12/23/2019 Software/
Informatics
13-111 Complete IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
09/17/2018 Materials 8-466 Complete ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
06/07/2018 Software/
Informatics
13-104 Complete UL ANSI 2900-2-1 First Edition 2017 Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
06/07/2018 Radiology 12-316 Complete IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
06/07/2018 Nanotechnology 18-9 Complete 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)].
09/17/2018 Orthopedic 11-336 Complete ISO 17853 Third edition 2011-03-01 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
09/17/2018 Orthopedic 11-338 Complete ISO 11491 First edition 2017-07 Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-117 Complete ISO 16038 Second edition 2017-11 Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
04/04/2016 Materials 8-114 Complete ASTM F2255-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading
08/21/2017 Materials 8-195 Complete ASTM F2024-10 (Reapproved 2016) Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
08/21/2017 Materials 8-428 Complete ASTM F1581-08 (Reapproved 2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
 
 
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