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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: Acertara Acoustic Laboratories LLC [TL-64]
    Accreditation Status: Accreditation Granted - Start Date: 04/29/2021
    Accreditation Body Organization Name: ANSI National Accreditation Board (ANAB)
    Test Lab Primary Contact: Callie Moore, cmoore@acertaralabs.com, 1950 Lefthand Creek Lane Longmont CO US 80501
     
    Scope of ASCA Accreditation
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    Status
    Status
    Date
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    Biocompatibility
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    Method
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    Recognition
    Number
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    Standards
    Development
    Organization
    Standard Designation
    Number and Date
    Title
    Exclusions
    Accreditation Granted 04/29/2021 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
    Only include the following clauses: 201.11.1.2.2; 201.11.1.3; 201.12.1; 201.12.4.2; Values per definitions summarized in table 201.101 and 201.103
    Accreditation Granted 04/29/2021 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
    Only include the following clauses: 201.10.102; 201.11.1.2.2; 201.11.1.3; 201.12.1.101; 201.12.1.105; 201.12.4.4.104; 201.12.4.4.105; 201.12.4.4.106; Values per definitions summarized in table 201.101
     
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    Exclusions
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