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U.S. Department of Health and Human Services

ASCA-Accredited Testing Laboratories
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This page lists ASCA-accredited testing laboratories and their respective scopes of accreditation.

Notes:

  • Testing laboratories who wish to participate in ASCA should demonstrate that they have been accredited by an ASCA-recognized accreditation body to the currently FDA-recognized versions of the standards and test methods included in ASCA. Please check the Recognized Consensus Standards database for the currently recognized versions.
  • Some FDA-recognized consensus standards included in ASCA have an identical U.S. adoption (for example, IEC 60601-2-47, ANSI/AAMI/IEC 60601-2-47). If a testing laboratory has an international (e.g., IEC, ISO) version of a standard in their scope of ASCA Accreditation, any identical US adoption associated with the FDA Recognition number is also considered included in the testing laboratory's scope. For example, if IEC 60601-2-47 with FDA Recognition number 3-155 is listed in a testing laboratory's scope of ASCA Accreditation, testing to the associated ANSI AAMI IEC version is also acceptable even if it is not explicitly listed in the testing lab's scope.
  • Some FDA-recognized international consensus standards (e.g., IEC, ISO) included in ASCA are recognized specifically with U.S. national differences applied (e.g., IEC 60601-1, IEC 61010-1). When U.S. national differences are applied to the international versions, they are considered equivalent to the corresponding U.S. adoptions of those standards (e.g., ANSI AAMI ES60601-1, ANSI UL 61010-1). For testing laboratories listed below with such standards in their scope, both the US adoptions and the international versions of the standards are considered as part of their scope of ASCA Accreditation.
  • As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.

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    Test Lab: Intertek Testing Services NA, Inc. - Menlo Park [TL-36]
    Accreditation Status: Accreditation Granted - Date: 04/12/2021
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Yaqing Liu, yaqing.liu@intertek.com, 1365 Adams Court Suite 200 Menlo Park CA US 94025
     
    Scope of ASCA Accreditation Return to list of Testing Labs
    Status
    Status
    Date
    Sort by Standard Designation Number and Date [0 - 9]
    Sort by Standard Designation Number and Date [9 - 0]
    Category
    Sort by Standard Designation Number and Date [0 - 9]
    Sort by Standard Designation Number and Date [9 - 0]
    Biocompatibility
    Test
    Method
    Sort by Standard Designation Number and Date [0 - 9]
    Sort by Standard Designation Number and Date [9 - 0]
    Recognition
    Number
    Sort by Standard Designation Number and Date [0 - 9]
    Sort by Standard Designation Number and Date [9 - 0]
    Standards
    Development
    Organization
    Standard Designation
    Number and Date
    Title
    Exclusions
    Accreditation Granted 09/20/2024 Basic safety and essential performance   10-126 IEC 80601-2-58 Edition 2.0 2014-09 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
    Accreditation Granted 04/12/2021 Basic safety and essential performance   12-205 IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
    Accreditation Granted 04/12/2021 Basic safety and essential performance   12-268 IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    Accreditation Granted 04/12/2021 Basic safety and essential performance   12-293 IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
    Accreditation Granted 09/20/2024 Basic safety and essential performance   12-302 IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
    Accreditation Granted 09/20/2024 Basic safety and essential performance   12-319 IEC 60601-2-68 Edition 1.0 2014-09 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    Accreditation Granted 09/20/2024 Basic safety and essential performance   12-336 IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    Accreditation Granted 09/20/2024 Basic safety and essential performance   12-338 IEC 60601-2-1 Edition 4.0 2020-10 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
    Accreditation Granted 04/12/2021 Basic safety and essential performance   17-16 IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
    Accreditation Granted 04/12/2021 Basic safety and essential performance   19-34 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
    Excluding Clause 12.3 UV Radiation and Clause 12.5 Ultrasonic Pressure
    Accreditation Granted 05/08/2023 Basic safety and essential performance   19-36 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
    Accreditation Granted 09/20/2024 Basic safety and essential performance   19-37 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
    Accreditation Granted 09/20/2024 Basic safety and essential performance   19-38 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
    Accreditation Granted 09/20/2024 Basic safety and essential performance   19-39 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
    Accreditation Granted 05/08/2023 Basic safety and essential performance   19-46 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)]
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
    Accreditation Granted 09/20/2024 Basic safety and essential performance   19-47 AAMI, ANSI 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)]
    Accreditation Granted 09/20/2024 Basic safety and essential performance   19-49 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.
    Accreditation Granted 04/12/2021 Basic safety and essential performance   3-126 IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
    Accreditation Granted 09/20/2024 Basic safety and essential performance   3-155 IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
    Accreditation Granted 04/12/2021 Basic safety and essential performance   4-262 IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
    Accreditation Granted 09/20/2024 Basic safety and essential performance   5-131 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
    Accreditation Granted 09/20/2024 Basic safety and essential performance   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
    Accreditation Granted 04/12/2021 Basic safety and essential performance   6-389 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
    Accreditation Granted 04/12/2021 Basic safety and essential performance   6-421 ISO 80601-2-56 Second edition 2017-03 [Including AMD1:2018] 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)].
    Accreditation Granted 04/12/2021 Basic safety and essential performance   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
    Accreditation Granted 09/20/2024 Basic safety and essential performance   6-438 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
    Accreditation Granted 09/20/2024 Basic safety and essential performance   6-489 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
    Accreditation Granted 04/12/2021 Basic safety and essential performance   9-114 IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
     
    Scope History
    Action Type
    ASCA Status
    Effective
    Start Date
    Sort by Effective Date [0 - 9]
    Sort by Effective Date and Date [9 - 0]
    Biocompatibility
    Test Method
    Sort by Effective Date [0 - 9]
    Sort by Effective Date and Date [9 - 0]
    Recognition
    Number
    Sort by Recognition Number [0 - 9]
    Sort by Recognition Number [9 - 0]
    Designation Number
    Exclusions
    Transition Inactive 12/17/2023 12-285
    		 60601-2-1 Edition 3.1 2014-07
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
    Transition Inactive 12/17/2023 19-14
    		 60601-1-11 Edition 2.0 2015-01
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
    Transition Inactive 12/17/2023 19-15
    		 60601-1-12 Edition 1.0 2014-06
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
    Transition Inactive 12/17/2023 19-16
    		 HA60601-1-11:2015
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
    Transition Inactive 12/17/2023 19-4
    		 ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
    Transition Inactive 12/17/2023 19-8
    		 60601-1-2 Edition 4.0 2014-02
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
    Transition Inactive 12/17/2023 19-9
    		 60601-1-10 Edition 1.1 2013-11
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
    Transition Inactive 12/17/2023 5-76
    		 60601-1-8 Edition 2.1 2012-11
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
    Transition Inactive 12/17/2023 5-89
    		 60601-1-6 Edition 3.1 2013-10
    Excluding Cathode Ray Tube, and Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
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