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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/23/2019 General I (QS/
RM)
5-125 ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
07/06/2020 General I (QS/
RM)
5-126 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 ISTA 3B 2017 Packaged-Products for Less-Than-Truckload (LTL) Shipment
07/06/2020 General I (QS/
RM)
5-128 ISTA 3E 2017 Similar Packaged-Products in Unitized Loads of Truckload Shipment
07/06/2020 General I (QS/
RM)
5-129 ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices
07/06/2020 General I (QS/
RM)
5-130 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 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)]
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
12/21/2020 General I (QS/
RM)
5-132 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 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 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 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 ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
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
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
12/19/2022 General I (QS/
RM)
5-140 ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
12/19/2022 General I (QS/
RM)
5-141 ASME V&V 20-2009 (R2021) Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
07/15/2019 General Plastic Surgery/
General Hospital
6-11 ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
08/21/2017 General Plastic Surgery/
General Hospital
6-70 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 ASTM F1441-03 (Reapproved 2014) Standard Specification for Soft-Tissue Expander Devices
01/30/2014 General Plastic Surgery/
General Hospital
6-117 ASTM F2172-02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
01/15/2013 General Plastic Surgery/
General Hospital
6-122 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 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 ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
08/21/2017 General Plastic Surgery/
General Hospital
6-125 ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
07/15/2019 General Plastic Surgery/
General Hospital
6-129 ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
08/06/2013 General Plastic Surgery/
General Hospital
6-147 ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
08/06/2013 General Plastic Surgery/
General Hospital
6-174 ISO 11608-4 First edition 2006-03-15 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
03/16/2012 General Plastic Surgery/
General Hospital
6-177 ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
07/06/2020 General Plastic Surgery/
General Hospital
6-178 ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
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
08/14/2015 General Plastic Surgery/
General Hospital
6-185 ASTM F881-94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants
08/14/2015 General Plastic Surgery/
General Hospital
6-200 ASTM E1061-01 (Reapproved 2014) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
06/07/2018 General Plastic Surgery/
General Hospital
6-214 ASTM D6355-07 (Reapproved 2017) Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
03/18/2009 General Plastic Surgery/
General Hospital
6-215 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 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 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 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 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 ASTM F921-10 (Reapproved 2018) Standard Terminology Relating to Hemostatic Forceps
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
06/07/2018 General Plastic Surgery/
General Hospital
6-270 ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles
03/16/2012 General Plastic Surgery/
General Hospital
6-271 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 ASTM F2062-00 (Reapproved 2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
01/30/2014 General Plastic Surgery/
General Hospital
6-273 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
6-275 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
6-276 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 ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
08/06/2013 General Plastic Surgery/
General Hospital
6-294 ISO 11608-3 Second edition 2012-10-01 Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
08/06/2013 General Plastic Surgery/
General Hospital
6-295 ANSI AAMI BF7:2012 Blood transfusion microfilters
08/06/2013 General Plastic Surgery/
General Hospital
6-296 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 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 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 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 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 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 ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves
08/14/2015 General Plastic Surgery/
General Hospital
6-341 ISO 11608-1 Third edition 2014-12-15 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
08/14/2015 General Plastic Surgery/
General Hospital
6-353 ASTM F2051-00 (Reapproved 2014) Standard Specification for Implantable Saline Filled Breast Prosthesis
08/14/2015 General Plastic Surgery/
General Hospital
6-354 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 ASTM D3772-15 Standard Specification for Industrial Rubber Finger Cots
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
04/04/2016 General Plastic Surgery/
General Hospital
6-357 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 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 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 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 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 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 ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
06/27/2016 General Plastic Surgery/
General Hospital
6-377 ISO 11608-5 First edition 2012-10-01 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated function.
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
08/21/2017 General Plastic Surgery/
General Hospital
6-384 ISO 1135-4 Sixth edition 2015-12-01 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
08/21/2017 General Plastic Surgery/
General Hospital
6-385 ANSI AAMI IEC 60601-2-19:2009/(R)2014 & A1:2016 Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-19 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
08/21/2017 General Plastic Surgery/
General Hospital
6-386 ANSI AAMI IEC 60601-2-20:2009/A1:2016 Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Erratum (2012) and Amendment 1 (2016)]
IEC 60601-2-20 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)]
08/21/2017 General Plastic Surgery/
General Hospital
6-387 ANSI AAMI IEC 60601-2-50:2009/A1:2016 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
IEC 60601-2-50 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
08/21/2017 General Plastic Surgery/
General Hospital
6-388 ANSI AAMI IEC 60601-2-21:2009/A1:2016 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
IEC 60601-2-21 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
06/07/2021 General Plastic Surgery/
General Hospital
6-389 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
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
08/21/2017 General Plastic Surgery/
General Hospital
6-390 ANSI AAMI IEC 80601-2-35:2009/A1:2016 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
IEC 80601-2-35 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment-Part - 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)]
08/21/2017 General Plastic Surgery/
General Hospital
6-400 ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles
06/07/2018 General Plastic Surgery/
General Hospital
6-401 ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
06/07/2018 General Plastic Surgery/
General Hospital
6-402 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 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 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 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 ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
09/17/2018 General Plastic Surgery/
General Hospital
6-408 ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
09/17/2018 General Plastic Surgery/
General Hospital
6-409 ASTM F703-18 Standard Specification for Implantable Breast Prostheses
01/14/2019 General Plastic Surgery/
General Hospital
6-410 ISO 8536-6 Third edition 2016-12-01 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
01/14/2019 General Plastic Surgery/
General Hospital
6-411 ASTM D6499-18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
07/15/2019 General Plastic Surgery/
General Hospital
6-421 ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
07/15/2019 General Plastic Surgery/
General Hospital
6-422 AAMI TIR38:2019 Medical device safety assurance case guidance
07/15/2019 General Plastic Surgery/
General Hospital
6-423 IEC 60601-2-6 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
12/23/2019 General Plastic Surgery/
General Hospital
6-424 ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
12/23/2019 General Plastic Surgery/
General Hospital
6-425 ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
12/23/2019 General Plastic Surgery/
General Hospital
6-426 ISO 23907-1 First edition 2019-01 Sharps injury protection - Requirements and test methods - Sharps containers
12/23/2019 General Plastic Surgery/
General Hospital
6-427 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
12/23/2019 General Plastic Surgery/
General Hospital
6-437 ISO 23907-2 First edition 2019-11 Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
 
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