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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: Element Materials Technology Dallas-Plano West [TL-137]
    Accreditation Status: Accreditation Granted - Start Date: 10/23/2024
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Zach Keyser, zach.keyser@element.com, 1701 E. Plano Parkway, Suite 150 Plano TX US 75074
     
    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
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    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 10/07/2024 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
    EMC testing only
    Accreditation Granted 10/07/2024 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
    EMC testing only
    Accreditation Granted 10/07/2024 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)]
    EMC testing only
    Accreditation Granted 10/07/2024 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
    EMC testing only
    Accreditation Granted 10/07/2024 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
    EMC testing only
    Accreditation Granted 10/07/2024 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
    EMC testing only
    Accreditation Granted 10/07/2024 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 10/07/2024 Basic safety and essential performance   1-140 ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    EMC testing only
     
    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 10/28/2024 6-450
    		60601-2-50 Edition 3.0 2020-09
    EMC testing only
    Accredit Accreditation Granted 10/07/2024 1-140
    		80601-2-55 Second edition 2018-02
    EMC testing only
    Accredit Accreditation Granted 10/07/2024 19-36
    		60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
    Accredit Accreditation Granted 10/07/2024 3-105
    		60601-2-25 Edition 2.0 2011-10
    EMC testing only
    Accredit Accreditation Granted 10/07/2024 3-115
    		60601-2-34 Edition 3.0 2011-05
    EMC testing only
    Accredit Accreditation Granted 10/07/2024 3-123
    		80601-2-30: Edition 2.0 2018-03
    EMC testing only
    Accredit Accreditation Granted 10/07/2024 3-126
    		60601-2-27 Edition 3.0 2011-03
    EMC testing only
    Accredit Accreditation Granted 10/07/2024 3-155
    		60601-2-47 Edition 2.0 2012-02
    EMC testing only
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