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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: []
    Accreditation Status: - Start Date:
    Accreditation Body Organization Name:
    Test Lab Primary Contact: MA US 01460
     
    Scope of ASCA Accreditation
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    Status
    Status
    Date
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    Sort by Standard Designation Number and Date [9 - 0]
    Category
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    Biocompatibility
    Test
    Method
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    Recognition
    Number
    Sort by Standard Designation Number and Date [0 - 9]
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    Standards
    Development
    Organization
    Standard Designation
    Number and Date
    Title
    Exclusions
     
    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
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    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 07/02/2024 1-105
    		80601-2-72 First edition 2015-04-11
    Accredit Accreditation Granted 07/02/2024 1-115
    		80601-2-70 First Edition 2015-01-15
    Accredit Accreditation Granted 07/02/2024 1-138
    		80601-2-74 First edition 2017-05
    Accredit Accreditation Granted 07/02/2024 1-139
    		80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
    Accredit Accreditation Granted 07/02/2024 1-140
    		80601-2-55 Second edition 2018-02
    Accredit Accreditation Granted 07/02/2024 1-143
    		80601-2-79 First edition 2018-07
    Accredit Accreditation Granted 07/02/2024 1-144
    		80601-2-80 First edition 2018-07
    Accredit Accreditation Granted 07/02/2024 1-148
    		80601-2-69 Second edition 2020-11
    Accredit Accreditation Granted 07/02/2024 1-151
    		80601-2-70 Second edition 2020-11
    Accredit Accreditation Granted 07/02/2024 1-160
    		80601-2-84 First edition 2020-07
    Accredit Accreditation Granted 07/02/2024 1-98
    		80601-2-12 First edition 2011-04-15
    Accredit Accreditation Granted 07/02/2024 12-242
    		60601-2-57 Edition 1.0 2011-01
    Accredit Accreditation Granted 07/02/2024 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 07/02/2024 12-293
    		60601-2-37 Edition 2.1 2015
    Accredit Accreditation Granted 07/02/2024 17-16
    		60601-2-10 Edition 2.1 2016-04
    Accredit Accreditation Granted 07/02/2024 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 19-36
    		60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 19-37
    		60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 19-41
    		61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
    Accredit Accreditation Granted 07/02/2024 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 07/02/2024 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 3-105
    		60601-2-25 Edition 2.0 2011-10
    Accredit Accreditation Granted 07/02/2024 3-123
    		80601-2-30: Edition 2.0 2018-03
    Accredit Accreditation Granted 07/02/2024 3-126
    		60601-2-27 Edition 3.0 2011-03
    Accredit Accreditation Granted 07/02/2024 3-155
    		60601-2-47 Edition 2.0 2012-02
    Accredit Accreditation Granted 07/02/2024 4-262
    		80601-2-60 Edition 2.0 2019-06
    Accredit Accreditation Granted 07/02/2024 5-131
    		60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 6-321
    		60601-2-52 Edition 1.0 2009-12
    Accredit Accreditation Granted 07/02/2024 6-421
    		80601-2-56 Second edition 2017-03
    Accredit Accreditation Granted 07/02/2024 6-438
    		80601-2-77 Edition 1.0 2019-07
    Accredit Accreditation Granted 07/02/2024 6-483
    		60601-2-35 Edition 2.0 2020-09
    Accredit Accreditation Granted 07/02/2024 6-489
    		60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 9-114
    		60601-2-18: Edition 3.0 2009-08
    Accredit Accreditation Granted 07/02/2024 9-121
    		60601-2-16 Edition 5.0 2018-4
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-105
    		80601-2-72 First edition 2015-04-11
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-115
    		80601-2-70 First Edition 2015-01-15
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-138
    		80601-2-74 First edition 2017-05
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-139
    		80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-140
    		80601-2-55 Second edition 2018-02
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-143
    		80601-2-79 First edition 2018-07
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-144
    		80601-2-80 First edition 2018-07
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-148
    		80601-2-69 Second edition 2020-11
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-151
    		80601-2-70 Second edition 2020-11
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-160
    		80601-2-84 First edition 2020-07
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 1-98
    		80601-2-12 First edition 2011-04-15
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 12-242
    		60601-2-57 Edition 1.0 2011-01
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 12-268
    		60601-2-22 Edition 3.1 2012-10
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 12-293
    		60601-2-37 Edition 2.1 2015
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 17-16
    		60601-2-10 Edition 2.1 2016-04
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 19-36
    		60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 19-37
    		60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 19-41
    		61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 19-46
    		ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 3-105
    		60601-2-25 Edition 2.0 2011-10
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 3-123
    		80601-2-30: Edition 2.0 2018-03
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 3-126
    		60601-2-27 Edition 3.0 2011-03
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 3-155
    		60601-2-47 Edition 2.0 2012-02
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 4-262
    		80601-2-60 Edition 2.0 2019-06
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 5-131
    		60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 6-321
    		60601-2-52 Edition 1.0 2009-12
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 6-421
    		80601-2-56 Second edition 2017-03 [Including AMD1:2018]
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 6-438
    		80601-2-77 Edition 1.0 2019-07
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 6-483
    		60601-2-35 Edition 2.0 2020-09
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 6-489
    		60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 9-114
    		60601-2-18: Edition 3.0 2009-08
    Vol Withdraw Voluntarily Withdrawn 12/30/2025 9-121
    		60601-2-16 Edition 5.0 2018-4
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