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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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.
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)]
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
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
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
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)]
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
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)]
12/23/2019 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
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.
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
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
12/23/2019 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
12/19/2022 General II (ES/
EMC)
19-48 Complete IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
07/09/2014 General II (ES/
EMC)
19-11 Complete UL 2054 2nd Edition Household and Commercial Batteries
12/23/2024 General II (ES/
EMC)
19-53 Complete IEC TS 60601-4-6 Edition 1.0 2024-04 Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
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)]
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
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
12/23/2019 General Plastic Surgery/
General Hospital
6-426 Complete ISO 23907-1 First edition 2019-01 Sharps injury protection - Requirements and test methods - Sharps containers
05/29/2024 General Plastic Surgery/
General Hospital
6-501 Complete ISO 15747 Third edition 2018-09 Plastic containers for intravenous injections
05/29/2024 General Plastic Surgery/
General Hospital
6-498 Complete ISO 10555-4 Third edition 2023-11 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
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
05/29/2024 General Plastic Surgery/
General Hospital
6-500 Complete IEC 63045 Edition 1.0 2020-05 Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields
01/14/2019 General Plastic Surgery/
General Hospital
6-411 Complete ASTM D6499-18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
01/14/2019 General Plastic Surgery/
General Hospital
6-410 Complete ISO 8536-6 Third edition 2016-12-01 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
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
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
12/23/2024 General Plastic Surgery/
General Hospital
6-503 Complete ISO 16571 Second edition 2024-03 Systems for evacuation of plume generated by medical device
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
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
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
04/04/2016 General Plastic Surgery/
General Hospital
6-355 Complete ASTM D3772-15(2021) Standard Specification for Industrial Rubber Finger Cots
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
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
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
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
6-270 Complete ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles
03/16/2012 General Plastic Surgery/
General Hospital
6-268 Complete ASTM F921-10 (Reapproved 2018) Standard Terminology Relating to Hemostatic Forceps
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
08/06/2013 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
12/20/2021 General Plastic Surgery/
General Hospital
6-471 Complete USP-NF M88880_05_01 Sterile Water for Irrigation
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
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
08/14/2015 General Plastic Surgery/
General Hospital
6-185 Complete ASTM F881-94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants
12/20/2021 General Plastic Surgery/
General Hospital
6-469 Complete USP-NF M99650_02_01 <861> Sutures - Diameter
08/14/2015 General Plastic Surgery/
General Hospital
6-200 Complete ASTM E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
01/14/2019 General Plastic Surgery/
General Hospital
6-338 Complete ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves
07/15/2019 General Plastic Surgery/
General Hospital
6-422 Complete AAMI TIR38:2019 Medical device safety assurance case guidance
07/15/2019 General Plastic Surgery/
General Hospital
6-421 Complete 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)].
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
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
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
07/15/2019 General Plastic Surgery/
General Hospital
6-423 Complete 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
12/20/2021 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)]
12/23/2019 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.
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
05/29/2023 General Plastic Surgery/
General Hospital
6-495 Complete ISO 20698 First Edition 2018-07 Catheter systems for neuraxial application - Sterile and single-use catheters and accessories
05/29/2023 General Plastic Surgery/
General Hospital
6-490 Complete ISO 10555-6 First edition 2015-04-15 [Including AMD1:2019] Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)]
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
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
6-425 Complete ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
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
6-484 Complete ASTM F3502-22a Standard Specification for Barrier Face Coverings
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
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
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
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
08/06/2013 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
08/20/2012 General Plastic Surgery/
General Hospital
6-278 Complete ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
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
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
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
6-427 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
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
12/20/2021 General Plastic Surgery/
General Hospital
6-470 Complete USP-NF M99660_03_01 <871> Sutures - Needle Attachment
06/07/2018 General Plastic Surgery/
General Hospital
6-407 Complete ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
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
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
12/20/2021 General Plastic Surgery/
General Hospital
6-473 Complete USP-NF M80190_04_01 Absorbable Surgical Suture
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
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
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
08/21/2017 General Plastic Surgery/
General Hospital
6-400 Complete ASTM F3212-16(2023) Standard Test Method for Coring Testing of Huber Needles
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
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
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
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
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
12/23/2019 General Plastic Surgery/
General Hospital
6-438 Complete IEC 80601-2-77 Edition 1.0 2019-07 Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
ANSI AAMI IEC 80601-2-77:2020 Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
 
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