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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: MEDTRONIC PLC. (RELIABILITY ASSURANCE & DESIGN ASSURANCE LABORATORIES) [TL-121]
    Accreditation Status: Accreditation Granted - Start Date: 10/04/2023
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Michael Simpeh, SR, michael.simpeh@medtronic.com, 7000 Central Ave NE Fridley MN US 55432
     
    Scope of ASCA Accreditation
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    		Return to list of Testing Labs
    Status
    Status
    Date
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    Category
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    Biocompatibility
    Test
    Method
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    Recognition
    Number
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    Standards
    Development
    Organization
    Standard Designation
    Number and Date
    Title
    Exclusions
    Accreditation Granted 10/04/2023 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.
    ALL subclauses except subclauses 7.1.2, 7.1.3, 15.3.4.1 and 15.3.4.2
    Accreditation Granted 10/04/2023 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)]
    ALL subclauses except subclauses 7.1.2, 7.1.3, 15.3.4.1 and 15.3.4.2
     
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    Action Type
    ASCA Status
    Effective
    Start Date
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    Biocompatibility
    Test Method
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    Recognition
    Number
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    Designation Number
    Exclusions
    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)
    ALL subclauses except subclauses 7.1.2, 7.1.3, 15.3.4.1 and 15.3.4.2
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