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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Standard Title
(click for recognition information)
 
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
12/18/2023 Dental/
ENT
4-321 Complete ISO 23450 First edition 2021-03 Dentistry - Intraoral camera
12/18/2023 Dental/
ENT
4-322 Complete ISO 18675 First edition 2022-05 Dentistry - Machinable ceramic blanks
12/18/2023 Dental/
ENT
4-323 Complete ISO 5139 First edition 2023-05 Dentistry - Polymer-based composite machinable blanks
12/18/2023 Dental/
ENT
4-324 Complete ISO TS 16506 First edition 2018-03 Dentistry - Polymer-based luting materials containing adhesive components
09/17/2018 General I (QS/
RM)
5-42 Complete ASTM D903-98 (Reapproved 2017) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
01/30/2014 General I (QS/
RM)
5-47 Complete ISO 10012 First edition 2003-01-15 Measurement management systems - Requirements for measurement processes and measuring equipment
01/27/2015 General I (QS/
RM)
5-48 Complete ANSI Z1.9-2003 (R2018) Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
06/27/2016 General I (QS/
RM)
5-57 Partial ANSI AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices
01/27/2015 General I (QS/
RM)
5-62 Complete ANSI ASQ Z1.4-2003 (R2018) Sampling Procedures and Tables for Inspection by Attributes
01/30/2014 General I (QS/
RM)
5-84 Complete AAMI TIR 49:2013/(R)2020 Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments
07/09/2014 General I (QS/
RM)
5-88 Complete ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
08/14/2015 General I (QS/
RM)
5-97 Complete ISO 80369-20 First edition 2015-05-15 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ANSI AAMI ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
04/04/2016 General I (QS/
RM)
5-98 Complete ANSI ESD S20.20-2014 Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
06/15/2016 General I (QS/
RM)
5-102 Complete IEC 60417:2002 DB Graphical symbols for use on equipment
08/21/2017 General I (QS/
RM)
5-107 Complete 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)]
ANSI AAMI ISO 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
06/27/2016 General I (QS/
RM)
5-108 Complete ISO 80369-6 First Edition 2016-03-15 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
12/23/2016 General I (QS/
RM)
5-113 Complete ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
01/14/2019 General I (QS/
RM)
5-120 Complete IEC 60812 Edition 3.0 2018-08 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
01/14/2019 General I (QS/
RM)
5-121 Complete ISO 80369-1 Second edition 2018-11 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
01/14/2019 General I (QS/
RM)
5-122 Complete ASME V&V 40-2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices
07/15/2019 General I (QS/
RM)
5-123 Complete ISO 80369-3 First Edition 2016-07-01 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
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 General I (QS/
RM)
5-125 Complete ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
07/06/2020 General I (QS/
RM)
5-126 Complete ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
07/06/2020 General I (QS/
RM)
5-127 Complete ISTA 3B 2017 Packaged-Products for Less-Than-Truckload (LTL) Shipment
07/06/2020 General I (QS/
RM)
5-128 Complete ISTA 3E 2017 Similar Packaged-Products in Unitized Loads of Truckload Shipment
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
07/06/2020 General I (QS/
RM)
5-130 Complete ISO 7010 Third edition 2019-07 Graphical symbols - Safety colours and safety signs - Registered safety signs
12/21/2020 General I (QS/
RM)
5-131 Complete IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]
12/21/2020 General I (QS/
RM)
5-132 Complete IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/21/2020 General I (QS/
RM)
5-133 Complete ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
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
12/19/2022 General I (QS/
RM)
5-135 Complete 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)
5-136 Complete ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
12/19/2022 General I (QS/
RM)
5-137 Complete IEC TR 60878 Ed. 4.0 2022-11 Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)]
12/19/2022 General I (QS/
RM)
5-138 Complete 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 Complete ISO 18250-3 First edition 2018-06 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
12/19/2022 General I (QS/
RM)
5-140 Complete ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
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
08/21/2017 General Plastic Surgery/
General Hospital
6-70 Complete ASTM E825-98 (Reapproved 2016) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
08/14/2015 General Plastic Surgery/
General Hospital
6-110 Complete ASTM F1441-03 (Reapproved 2014) Standard Specification for Soft-Tissue Expander Devices
01/30/2014 General Plastic Surgery/
General Hospital
6-117 Complete ASTM F2172-02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
01/15/2013 General Plastic Surgery/
General Hospital
6-122 Complete ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
09/17/2018 General Plastic Surgery/
General Hospital
6-123 Complete ASTM E667-98 (Reapproved 2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
08/21/2017 General Plastic Surgery/
General Hospital
6-124 Complete ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
08/21/2017 General Plastic Surgery/
General Hospital
6-125 Complete ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
08/06/2013 General Plastic Surgery/
General Hospital
6-147 Complete ASTM D6978-05(2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
03/16/2012 General Plastic Surgery/
General Hospital
6-177 Complete ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
07/06/2020 General Plastic Surgery/
General Hospital
6-178 Partial ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
08/06/2013 General Plastic Surgery/
General Hospital
6-179 Complete ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods
08/14/2015 General Plastic Surgery/
General Hospital
6-185 Complete ASTM F881-94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants
08/14/2015 General Plastic Surgery/
General Hospital
6-200 Complete ASTM E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
06/07/2018 General Plastic Surgery/
General Hospital
6-214 Complete ASTM D6355-07(2022) Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
03/18/2009 General Plastic Surgery/
General Hospital
6-215 Complete ASTM F2132-01 (Reapproved 2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
08/06/2013 General Plastic Surgery/
General Hospital
6-216 Complete ISO 8536-7 Third edition 2009-01-15 Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles
08/06/2013 General Plastic Surgery/
General Hospital
6-240 Complete ISO 8536-3 Third edition 2009-06-01 Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles
08/20/2012 General Plastic Surgery/
General Hospital
6-242 Complete ISO 8536-2 Third edition 2010-03-15 Infusion equipment for medical use - Part 2: Closures for infusion bottles
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
03/16/2012 General Plastic Surgery/
General Hospital
6-268 Complete ASTM F921-10 (Reapproved 2018) Standard Terminology Relating to Hemostatic Forceps
03/16/2012 General Plastic Surgery/
General Hospital
6-269 Complete ASTM F1078-10 (Reapproved 2018) Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades
06/07/2018 General Plastic Surgery/
General Hospital
6-270 Complete ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles
03/16/2012 General Plastic Surgery/
General Hospital
6-271 Complete ASTM F1874-98 (Reapproved 2011) Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
03/16/2012 General Plastic Surgery/
General Hospital
6-272 Complete ASTM F2062-00 (Reapproved 2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
01/30/2014 General Plastic Surgery/
General Hospital
6-273 Complete ISO 23908 First edition 2011-06-11 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
08/06/2013 General Plastic Surgery/
General Hospital
6-276 Complete ISO 8536-1 Fourth edition 2011-09-01 Infusion equipment for medical use - Part 1: Infusion glass bottles
08/20/2012 General Plastic Surgery/
General Hospital
6-278 Complete ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
08/06/2013 General Plastic Surgery/
General Hospital
6-295 Complete AAMI ANSI BF7:2012 Blood transfusion microfilters
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
01/30/2014 General Plastic Surgery/
General Hospital
6-303 Complete ISO 10555-5 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters
01/30/2014 General Plastic Surgery/
General Hospital
6-305 Complete ISO 10555-3 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
01/30/2014 General Plastic Surgery/
General Hospital
6-306 Complete 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
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)]
01/30/2014 General Plastic Surgery/
General Hospital
6-322 Complete ISO 10555-4 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters
01/14/2019 General Plastic Surgery/
General Hospital
6-338 Complete ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves
08/14/2015 General Plastic Surgery/
General Hospital
6-353 Complete ASTM F2051-00 (Reapproved 2014) Standard Specification for Implantable Saline Filled Breast Prosthesis
08/14/2015 General Plastic Surgery/
General Hospital
6-354 Complete ASTM D7907-14 (Reapproved 2019) Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
04/04/2016 General Plastic Surgery/
General Hospital
6-355 Complete ASTM D3772-15(2021) Standard Specification for Industrial Rubber Finger Cots
04/04/2016 General Plastic Surgery/
General Hospital
6-356 Complete ASTM D5712-15(2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
04/04/2016 General Plastic Surgery/
General Hospital
6-357 Complete ISO 10555-6 First edition 2015-04-15 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports
04/04/2016 General Plastic Surgery/
General Hospital
6-358 Partial ISO 8536-8 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus
04/04/2016 General Plastic Surgery/
General Hospital
6-359 Partial ISO 8536-9 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment
04/04/2016 General Plastic Surgery/
General Hospital
6-360 Partial ISO 8536-10 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
04/04/2016 General Plastic Surgery/
General Hospital
6-361 Partial ISO 8536-11 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
06/27/2016 General Plastic Surgery/
General Hospital
6-363 Complete 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
06/27/2016 General Plastic Surgery/
General Hospital
6-364 Partial ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
09/21/2016 General Plastic Surgery/
General Hospital
6-379 Complete 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 Complete 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 Complete 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 Complete 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
08/21/2017 General Plastic Surgery/
General Hospital
6-384 Complete ISO 1135-4 Sixth edition 2015-12-01 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
06/07/2021 General Plastic Surgery/
General Hospital
6-389 Partial IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
ANSI AAMI IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
08/21/2017 General Plastic Surgery/
General Hospital
6-400 Complete ASTM F3212-16(2023) Standard Test Method for Coring Testing of Huber Needles
06/07/2018 General Plastic Surgery/
General Hospital
6-401 Complete ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
06/07/2018 General Plastic Surgery/
General Hospital
6-402 Complete ASTM F1670/F1670M-17 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
06/07/2018 General Plastic Surgery/
General Hospital
6-404 Complete ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
06/07/2018 General Plastic Surgery/
General Hospital
6-405 Complete IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
06/07/2018 General Plastic Surgery/
General Hospital
6-406 Complete ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
06/07/2018 General Plastic Surgery/
General Hospital
6-407 Complete ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
09/17/2018 General Plastic Surgery/
General Hospital
6-408 Partial ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
 
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