Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

ASCA-Accredited Testing Laboratories
  • Print
  • Share
  • E-mail
-

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.
  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here

    • Learn more...


    Arrow buttons can be used to sort the table by each column heading.

    Super Search Devices@FDA
    510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
    CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
    		 

    Test Lab: UL Solutions [TL-11]
    Accreditation Status: Accreditation Granted - Start Date: 04/12/2021
    Accreditation Body Organization Name: ANSI National Accreditation Board (ANAB)
    Test Lab Primary Contact: Bill Bisenius, william.bisenius@cpt.eurofinsus.com, 901 Sheldon Drive Unit B Cary NC US 27513
     
    Scope of ASCA Accreditation
    export reports to excelExport to Excel
    		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   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 01/13/2025 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)]
    Accreditation Granted 07/27/2021 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 07/27/2021 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 01/13/2025 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 07/27/2021 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   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
    Accreditation Granted 07/27/2021 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 07/27/2021 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 06/21/2022 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 01/13/2025 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 01/13/2025 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
    Accreditation Granted 01/13/2025 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 06/21/2022 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 06/21/2022 Basic safety and essential performance   12-340 IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
    Accreditation Granted 04/12/2021 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 04/12/2021 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 06/21/2022 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 07/27/2021 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 07/27/2021 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
     
    Scope History toggle icon(select icon to view/hide 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
    Accredit Accreditation Granted 07/27/2021 3-115
    		60601-2-34 Edition 3.0 2011-05
    Accredit Accreditation Granted 04/12/2021 6-321
    		60601-2-52 Edition 1.0 2009-12
    Accredit Accreditation Granted 06/21/2022 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 07/27/2021 3-105
    		60601-2-25 Edition 2.0 2011-10
    Accredit Accreditation Granted 07/27/2021 17-16
    		60601-2-10 Edition 2.1 2016-04
    Accredit Accreditation Granted 07/27/2021 12-293
    		60601-2-37 Edition 2.1 2015
    Accredit Accreditation Granted 07/27/2021 3-126
    		60601-2-27 Edition 3.0 2011-03
    Accredit Accreditation Granted 04/12/2021 5-89
    		60601-1-6 Edition 3.1 2013-10
    Accredit Accreditation Granted 06/21/2022 19-9
    		60601-1-10 Edition 1.1 2013-11
    Accredit Accreditation Granted 06/21/2022 19-14
    		60601-1-11 Edition 2.0 2015-01
    Accredit Accreditation Granted 04/12/2021 19-15
    		60601-1-12 Edition 1.0 2014-06
    Accredit Accreditation Granted 06/21/2022 12-269
    		60601-1-3 Edition 2.1 2013-04
    Accredit Accreditation Granted 07/27/2021 12-311
    		60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/27/2021 6-389
    		60601-2-2 Edition 6.0 2017-03
    Accredit Accreditation Granted 04/12/2021 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 19-16
    		HA60601-1-11:2015
    Accredit Accreditation Granted 07/27/2021 3-115
    		60601-2-34 Edition 3.0 2011-05
    Accredit Accreditation Granted 04/12/2021 6-321
    		60601-2-52 Edition 1.0 2009-12
    Accredit Accreditation Granted 06/21/2022 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 07/27/2021 3-105
    		60601-2-25 Edition 2.0 2011-10
    Accredit Accreditation Granted 07/27/2021 17-16
    		60601-2-10 Edition 2.1 2016-04
    Accredit Accreditation Granted 07/27/2021 12-293
    		60601-2-37 Edition 2.1 2015
    Accredit Accreditation Granted 07/27/2021 3-126
    		60601-2-27 Edition 3.0 2011-03
    Accredit Accreditation Granted 04/12/2021 5-89
    		60601-1-6 Edition 3.1 2013-10
    Accredit Accreditation Granted 06/21/2022 19-9
    		60601-1-10 Edition 1.1 2013-11
    Accredit Accreditation Granted 06/21/2022 19-14
    		60601-1-11 Edition 2.0 2015-01
    Accredit Accreditation Granted 04/12/2021 19-15
    		60601-1-12 Edition 1.0 2014-06
    Accredit Accreditation Granted 06/21/2022 12-269
    		60601-1-3 Edition 2.1 2013-04
    Accredit Accreditation Granted 07/27/2021 12-311
    		60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/27/2021 6-389
    		60601-2-2 Edition 6.0 2017-03
    Accredit Accreditation Granted 04/12/2021 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 19-4
    		ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Accredit Accreditation Granted 04/12/2021 19-16
    		HA60601-1-11:2015
    Accredit Accreditation Granted 07/27/2021 9-114
    		60601-2-18: Edition 3.0 2009-08
    Accredit Accreditation Granted 07/27/2021 9-114
    		60601-2-18: Edition 3.0 2009-08
    Accredit Accreditation Granted 04/12/2021 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 06/21/2022 19-37
    		60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 06/21/2022 19-37
    		60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 06/21/2022 12-336
    		60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 06/21/2022 12-336
    		60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 06/21/2022 12-340
    		60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION
    Accredit Accreditation Granted 06/21/2022 12-340
    		60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION
    Accredit Accreditation Granted 01/13/2025 19-41
    		61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
    Accredit Accreditation Granted 01/13/2025 19-46
    		ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
    Accredit Accreditation Granted 01/13/2025 19-47
    		HA60601-1-11:2015 [Including AMD1:2021]
    Accredit Accreditation Granted 01/13/2025 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Accredit Accreditation Granted 01/13/2025 6-489
    		60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
    -
    -