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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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01/14/2019 General Plastic Surgery/
General Hospital
6-338 Complete ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves
05/29/2023 General Plastic Surgery/
General Hospital
6-488 Complete ASTM F1671/F1671M-22 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
05/29/2023 General Plastic Surgery/
General Hospital
6-489 Complete IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
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)]
12/23/2019 General Plastic Surgery/
General Hospital
6-425 Complete ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
05/29/2024 General Plastic Surgery/
General Hospital
6-502 Complete ISO 23217 First Edition 2024-02 Injection systems for self-administration by paediatric patients - Requirements and guidelines for design
05/29/2023 General Plastic Surgery/
General Hospital
6-491 Complete ASTM F1670/F1670M-17a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
06/07/2018 General Plastic Surgery/
General Hospital
6-402 Complete ASTM F1670/F1670M-17 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/30/2022 General Plastic Surgery/
General Hospital
6-477 Complete ISO 11608-3:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
05/30/2022 General Plastic Surgery/
General Hospital
6-475 Complete ISO 11608-4:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
12/23/2019 General Plastic Surgery/
General Hospital
6-437 Complete ISO 23907-2 First edition 2019-11 Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
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
12/20/2021 General Plastic Surgery/
General Hospital
6-464 Complete ISO 11040-4 Third edition 2015-04-01 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
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
05/29/2023 General Plastic Surgery/
General Hospital
6-494 Complete ASTM F3352/F3352M-23a Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
12/19/2022 General Plastic Surgery/
General Hospital
6-485 Complete ISO 7886-4 Second Edition 2018-11 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
12/20/2021 General Plastic Surgery/
General Hospital
6-471 Complete USP-NF M88880_05_01 Sterile Water for Irrigation
08/14/2015 General Plastic Surgery/
General Hospital
6-185 Complete ASTM F881-94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants
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
07/06/2020 General Plastic Surgery/
General Hospital
6-444 Complete ASTM D7103-19(2023) Standard Guide for Assessment of Medical Gloves
06/07/2021 General Plastic Surgery/
General Hospital
6-461 Complete IEC 60601-2-19 Edition 3.0 2020-09 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
05/30/2022 General Plastic Surgery/
General Hospital
6-479 Complete ISO 11608-5:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
05/30/2022 General Plastic Surgery/
General Hospital
6-476 Complete ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
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
12/21/2020 General Plastic Surgery/
General Hospital
6-450 Complete IEC 60601-2-50 Edition 3.0 2020-09 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
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.
12/23/2019 General Plastic Surgery/
General Hospital
6-424 Complete ASTM D5151-19(2023) Standard Test Method for Detection of Holes in Medical Gloves
12/19/2022 General Plastic Surgery/
General Hospital
6-484 Complete ASTM F3502-22a Standard Specification for Barrier Face Coverings
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
6-465 Complete USP-NF M76090_03_01 Sodium Chloride Irrigation
05/30/2022 General Plastic Surgery/
General Hospital
6-480 Complete 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 Complete 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 Complete AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
05/29/2023 General Plastic Surgery/
General Hospital
6-486 Complete ISO 10535 Third edition 2021-10 Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
05/30/2022 General Plastic Surgery/
General Hospital
6-478 Complete ISO 11608-1:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
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
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
6-361 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
07/06/2020 General Plastic Surgery/
General Hospital
6-446 Partial ASTM D6319-19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application
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
6-268 Complete ASTM F921-10 (Reapproved 2018) Standard Terminology Relating to Hemostatic Forceps
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
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
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
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
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
07/06/2020 General Plastic Surgery/
General Hospital
6-443 Partial ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
07/06/2020 General Plastic Surgery/
General Hospital
6-178 Partial ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
12/21/2020 General Plastic Surgery/
General Hospital
6-448 Partial ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
12/21/2020 General Plastic Surgery/
General Hospital
6-449 Partial ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs
07/06/2020 General Plastic Surgery/
General Hospital
6-440 Partial ASTM D3578-19(2023) Standard Specification for Rubber Examination Gloves
12/20/2021 General Plastic Surgery/
General Hospital
6-474 Partial ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
05/29/2023 General Plastic Surgery/
General Hospital
6-496 Partial ASTM F739-20 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
12/18/2023 General Plastic Surgery/
General Hospital
6-497 Partial ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves
05/29/2023 General Plastic Surgery/
General Hospital
6-487 Partial ANSI AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
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
6-360 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
07/06/2020 General Plastic Surgery/
General Hospital
6-442 Partial ASTM D6977-19(2023) Standard Specification for Polychloroprene Examination Gloves for Medical Application
07/06/2020 General Plastic Surgery/
General Hospital
6-445 Partial ASTM D5250-19(2023) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
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)]
07/09/2014 General II (ES/
EMC)
19-11 Complete UL 2054 2nd Edition Household and Commercial Batteries
02/07/2022 General II (ES/
EMC)
19-45 Complete AIM Standard 7351731 Rev. 3.00 2021-06-04 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
04/03/2023 General II (ES/
EMC)
19-49 Complete IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
12/19/2022 General II (ES/
EMC)
19-48 Complete IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
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
05/30/2022 General II (ES/
EMC)
19-47 Complete ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
12/21/2020 General II (ES/
EMC)
19-37 Complete IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
04/03/2023 General II (ES/
EMC)
19-34 Complete 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)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section
08/21/2017 General II (ES/
EMC)
19-22 Complete AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
08/21/2017 General II (ES/
EMC)
19-24 Complete IEC 60086-5 Edition 4.0 2016-07 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
08/21/2017 General II (ES/
EMC)
19-26 Complete IEC 62485-2 Edition 1.0 2010-06 Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries.
08/21/2017 General II (ES/
EMC)
19-28 Complete IEC 62485-4 Edition 1.0 2015-01 Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances
07/09/2014 General II (ES/
EMC)
19-10 Complete UL 1642 5th Edition Lithium Batteries
12/23/2019 General II (ES/
EMC)
19-32 Complete IEC 62133-1 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems
08/21/2017 General II (ES/
EMC)
19-25 Complete IEC 62485-1 Edition 1.0 2015-04 Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
08/21/2017 General II (ES/
EMC)
19-27 Complete IEC 62485-3 Edition 2.0 2014-07 Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
12/23/2019 General II (ES/
EMC)
19-33 Complete IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
09/17/2018 General II (ES/
EMC)
19-31 Complete IEEE ANSI C63.15-2017 (Revision of ANSI C63.15-2010) American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
04/04/2016 General II (ES/
EMC)
19-17 Complete IEEE ANSI C63.18-2014 American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
12/23/2019 General II (ES/
EMC)
19-13 Complete IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
12/23/2016 General II (ES/
EMC)
19-20 Complete IEEE ANSI C63.16-2016 (Revision of ANSI C63.16-1993) American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
12/21/2020 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)]
05/30/2022 General II (ES/
EMC)
19-46 Complete ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
06/07/2021 General II (ES/
EMC)
19-40 Complete IEC 60086-4 Edition 5.0 2019-04 Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
12/20/2021 General II (ES/
EMC)
19-41 Complete 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 General II (ES/
EMC)
19-19 Partial IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
05/29/2024 General II (ES/
EMC)
19-50 Partial IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
12/21/2020 General II (ES/
EMC)
19-36 Partial IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]
12/20/2021 General II (ES/
EMC)
19-43 Partial IEC 61326-2-6 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
12/21/2020 General II (ES/
EMC)
19-38 Partial IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
12/20/2021 General II (ES/
EMC)
19-42 Partial IEC 61326-1 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
07/15/2019 General II (ES/
EMC)
19-35 Complete UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
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
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
12/23/2019 General I (QS/
RM)
5-124 Complete ISO 7000 Sixth edition 2019-07 Graphical symbols for use on equipment - Registered symbols
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
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
06/15/2016 General I (QS/
RM)
5-102 Complete IEC 60417:2002 DB Graphical symbols for use on equipment
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
 
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