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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.
  • Labs listed below with a status of "FDA Initiated Withdrawal" have had their ASCA Accreditation withdrawn as a result of failing to meet the requirements of the ASCA Program as detailed in Section 514(d) of the FD&C Act and the relevant ASCA guidance documents. For some labs listed with a status of "FDA Initiated Withdrawal," the FDA has identified data integrity concerns with testing conducted by the testing laboratory and submitted to the agency in premarket submissions.
  • Labs listed below with a status of "Voluntarily Withdrawn" have requested that their ASCA Accreditation be withdrawn voluntarily. This is often due to business decisions (e.g. closing of or moving the laboratory location, limited laboratory services, etc.).
  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here

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    Test Lab: Retlif Testing Laboratories - Pennsylvania [TL-74]
    Accreditation Status: Accreditation Granted - Start Date: 06/10/2021
    Accreditation Body Organization Name: ANSI National Accreditation Board (ANAB)
    Test Lab Primary Contact: Richard Reitz, rreitz@retlif.com, 3131 Detwiler Road Building 220-6E-E04 Harleysville PA US 19438
     
    Scope of ASCA Accreditation
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    		Return to list of Testing Labs
    Status
    Status
    Date
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    Biocompatibility
    Test
    Method
    Sort by Standard Designation Number and Date [0 - 9]
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    Recognition
    Number
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    Standards
    Development
    Organization
    Standard Designation
    Number and Date
    Title
    Exclusions
    Accreditation Granted 06/10/2021 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
    Excluding all except the following clauses: 201.17 and 202
    Accreditation Granted 06/10/2021 Basic safety and essential performance   12-302 IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
    Excluding all except clause 201.17
    Accreditation Granted 06/10/2021 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
    Excluding all except the following clauses: 201.17 and 202
    Accreditation Granted 06/10/2021 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
    Excluding all except the following clauses: 201.17 and 202
    Accreditation Granted 06/10/2021 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
    Excluding all except the following clauses: 201.17 and 202
    Accreditation Granted 06/10/2021 Basic safety and essential performance   6-321 IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
    Excluding all except clause 201.17
    Accreditation Granted 06/10/2021 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
    Excluding all except the following clauses: 201.17 and 202
     
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    Action Type
    ASCA Status
    Effective
    Start Date
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    Sort by Effective Date and Date [9 - 0]
    Biocompatibility
    Test Method
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    Recognition
    Number
    Sort by Recognition Number [0 - 9]
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    Designation Number
    Exclusions
    Transition Inactive 12/17/2023 12-311
    		 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION
    Excluding all except the following clauses: 201.17 & 202
    Transition Inactive 12/17/2023 19-14
    		 60601-1-11 Edition 2.0 2015-01
    Excluding all except clause 12
    Transition Inactive 12/17/2023 19-15
    		 60601-1-12 Edition 1.0 2014-06
    Excluding all except clause 11
    Transition Inactive 12/17/2023 19-8
    		 60601-1-2 Edition 4.0 2014-02
    Transition Inactive 12/17/2023 6-385
    		 60601-2-19 Edition 2.1 2016-04
    Excluding all except the following clauses: 201.17 and 202
    Transition Inactive 12/17/2023 6-386
    		 60601-2-20 Edition 2.1 2016-04
    Excluding all except the following clauses: 201.17 and 202
    Transition Inactive 12/17/2023 6-388
    		 60601-2-21 Edition 2.1 2016-04
    Excluding all except the following clauses: 201.17 and 202
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