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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  • As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.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. - Duluth [TL-32]
    Accreditation Status: Accreditation Granted - Date: 04/12/2021
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Yaqing Liu, Yaqing.liu@intertek.com, 1950 Evergreen Boulevard Suite 100 Duluth GA US 30096
     
    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 04/12/2021 Basic safety and essential performance   1-139 ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
    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
    Excluding Cl.201.12 ultrasound acoustic pressure, intensity and power
    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
    Excluding Cl. 201.12 Ultrasound Acoustic Pressure, Intensity and Power - Thermal and Mechanical indices
    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 Cl.12.2 Ionizing Radiation, Cl. 12.3 Optical Radiation per IEC 62471, Cl. 12.5.2 Ultrasonic Pressure, Cl. 12.5 Laser Sources per IEC 60825-1
    Accreditation Granted 02/28/2024 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 02/28/2024 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 02/28/2024 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
    excluding Cl. 10.1.2 Shock and 10.1.3 (a), (b), (c) Vibration
    Accreditation Granted 02/28/2024 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 Cl.12.2 Ionizing Radiation; Cl. 12.3 Optical Radiation per IEC 62471, Cl. 12.5.2 Ultrasonic Pressure, Cl. 12.5 Laser Sources per IEC 60825-1
    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 Cl. 9.5.2 Cathode ray tube test; Cl. 9.6.3 Hand-transmitted vibration per ISO 5349-1, Cl. 10.4 LED test per IEC 62471 and Laser test Select to expand and show more non-recognition rationale text
    Accreditation Granted 02/28/2024 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)]
    Excluding Cl. 10.1.2 Shock and 10.1.3 (a), (b), (c) Vibration
    Accreditation Granted 02/28/2024 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 Cl. 9.5.2 Cathode ray tube test; Cl. 9.6.3 Hand-transmitted vibration per ISO 5349-1, Cl. 10.4 LED test per IEC 62471 and Laser test Select to expand and show more non-recognition rationale text
    Accreditation Granted 04/12/2021 Basic safety and essential performance   3-105 IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
    Accreditation Granted 04/12/2021 Basic safety and essential performance   3-115 IEC 60601-2-34 Edition 3.0 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
    Accreditation Granted 04/12/2021 Basic safety and essential performance   3-123 IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    Excluding Cl. 201.8.8.4.101 Mechanical and Thermal Resistance to Damage of the Enclosure of the Flexible Part of Heating Devices)
    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 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 02/28/2024 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 02/28/2024 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   6-321 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 Cathode Ray Tubes, Flammable Gases and Oxygen Bomb, Shock and Vibration
    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 02/28/2024 Basic safety and essential performance   6-450 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
    Accreditation Granted 02/28/2024 Basic safety and essential performance   6-483 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
    excluding Cl. 201.8.8.4.101 Mechanical and Thermal Resistance to Damage of the Enclosure of the Flexible Part of Heating Devices
    Accreditation Granted 02/28/2024 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
    Accreditation Granted 04/12/2021 Basic safety and essential performance   9-119 IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
     
    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 19-14
    		 60601-1-11 Edition 2.0 2015-01
    Excluding Cathode Ray Tubes, Flammable Gases and Oxygen Bomb, Shock and Vibration
    Transition Inactive 12/17/2023 19-16
    		 HA60601-1-11:2015
    Excluding Cathode Ray Tubes, Flammable Gases and Oxygen Bomb, Shock and Vibration
    Transition Inactive 12/17/2023 19-8
    		 60601-1-2 Edition 4.0 2014-02
    Excluding Cathode Ray Tubes, Flammable Gases and Oxygen Bomb, Shock and Vibration
    Transition Inactive 12/17/2023 19-9
    		 60601-1-10 Edition 1.1 2013-11
    Excluding Cathode Ray Tubes, Flammable Gases and Oxygen Bomb, Shock and Vibration
    Transition Inactive 12/17/2023 5-76
    		 60601-1-8 Edition 2.1 2012-11
    Excluding Cathode Ray Tubes, Flammable Gases and Oxygen Bomb, Shock and Vibration
    Transition Inactive 12/17/2023 5-89
    		 60601-1-6 Edition 3.1 2013-10
    Excluding Cathode Ray Tubes, Flammable Gases and Oxygen Bomb, Shock and Vibration
    Transition Inactive 12/17/2023 6-387
    		 60601-2-50 Edition 2.1 2016-04
    Excluding Cathode Ray Tubes, Flammable Gases and Oxygen Bomb, Shock and Vibration
    Transition Inactive 12/17/2023 6-390
    		 80601-2-35 Edition 2.1 2016-04
    Excluding Cathode Ray Tubes, Flammable Gases and Oxygen Bomb, Shock and Vibration
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