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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  • As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.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 Japan K.K. [TL-40]
    Accreditation Status: Accreditation Granted - Date: 04/12/2021
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Yaqing Liu, yaqing.liu@intertek.com, Yasuda Shibaura No.2 Bldg. 4F, 3-2-12, Kaigan, Minato-ku, Tokyo JP 108-0022
     
    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 01/09/2024 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
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 Basic safety and essential performance   12-295 IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 Basic safety and essential performance   12-309 IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 Basic safety and essential performance   12-339 IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 Basic safety and essential performance   12-347 IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 Basic safety and essential performance   12-348 IEC 60601-2-54 Edition 2.0 2022-09 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 Basic safety and essential performance   12-351 IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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 Ionizing Measurement, Laser Testing
    Accreditation Granted 01/09/2024 Basic safety and essential performance   19-41 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
    Excluding Ionizing Measurement, Laser Testing
    Accreditation Granted 01/09/2024 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 Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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.
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 Basic safety and essential performance   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)]
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more non-recognition rationale text
     
    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 12-269
    		 60601-1-3 Edition 2.1 2013-04
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more text
    Transition Inactive 12/17/2023 12-310
    		 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more text
    Transition Inactive 12/17/2023 12-317
    		 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more text
    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 Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Select to expand and show more text
    Transition Inactive 12/17/2023 5-89
    		 60601-1-6 Edition 3.1 2013-10
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more text
    Transition Inactive 12/25/2022 12-308
    		 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION
    Excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diodes, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Select to expand and show more text
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