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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here

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    Test Lab: UL Solutions - Baltimore [TL-45]
    Accreditation Status: Accreditation Granted - Start Date: 04/12/2021
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Lauren Taylor, quality@metlabs.us, 914 West Patapsco Avenue Suite 150 Baltimore MD US 21230
     
    Scope of ASCA Accreditation
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    		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 10/06/2026 Basic safety and essential performance   19-57 IEC 61326-2-6 Edition 4.0 2025-06 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
    Accreditation Granted 10/06/2026 Basic safety and essential performance   17-20 IEC 60601-2-40 Third edition 2024-12 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
    Accreditation Granted 10/06/2026 Basic safety and essential performance   6-521 IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 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 10/06/2026 Basic safety and essential performance   3-202 IEC 60601-2-34 Edition 4.0 2024-10 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
    Accreditation Granted 10/06/2026 Basic safety and essential performance   3-203 IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
    Accreditation Granted 10/06/2026 Basic safety and essential performance   12-380 IEC 60601-2-37 Edition 3.0 2024-07 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring 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 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   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 clauses 6.7.1.2, 10.5.3, 12.2.1, 12.5.2, 12.6, 13.3
    Accreditation Granted 10/06/2026 Basic safety and essential performance   12-356 IEC 60601-2-22 Edition 4.0 2019-11 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   12-268 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 10/06/2026 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 10/06/2026 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 10/06/2026 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   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 10/06/2026 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
     
    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 10/06/2026 12-356
    		60601-2-22 Edition 4.0 2019-11
    Accredit Accreditation Granted 10/06/2026 12-380
    		60601-2-37 Edition 3.0 2024-07
    Accredit Accreditation Granted 10/06/2026 17-20
    		60601-2-40 Third edition 2024-12
    Accredit Accreditation Granted 10/06/2026 19-36
    		60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
    Accredit Accreditation Granted 10/06/2026 19-41
    		61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
    Accredit Accreditation Granted 10/06/2026 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 10/06/2026 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Accredit Accreditation Granted 10/06/2026 19-57
    		61326-2-6 Edition 4.0 2025-06
    Accredit Accreditation Granted 10/06/2026 3-202
    		60601-2-34 Edition 4.0 2024-10
    Accredit Accreditation Granted 10/06/2026 3-203
    		80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION
    Accredit Accreditation Granted 10/06/2026 6-521
    		60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11
    Accredit Accreditation Granted 04/12/2021 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 04/12/2021 12-293
    		60601-2-37 Edition 2.1 2015
    Accredit Accreditation Granted 04/12/2021 12-317
    		60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 12-348
    		60601-2-54 Edition 2.0 2022-09
    Accredit Accreditation Granted 04/12/2021 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Excluding clauses 6.7.1.2, 10.5.3, 12.2.1, 12.5.2, 12.6, 13.3
    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 19-8
    		60601-1-2 Edition 4.0 2014-02
    Accredit Accreditation Granted 04/12/2021 3-115
    		60601-2-34 Edition 3.0 2011-05
    Accredit Accreditation Granted 04/12/2021 9-114
    		60601-2-18: Edition 3.0 2009-08
    Delete Administrative Deletion 05/23/2023 12-348
    		60601-2-54 Edition 2.0 2022-09
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