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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: HCT America, Inc. [TL-136]
    Accreditation Status: Accreditation Granted - Start Date: 07/12/2024
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Sunwoo Kim, sunwoo@hctamerica.com, 840 Yosemite Way Milpitas CA US 95035
     
    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
    Sort by Standard Designation Number and Date [0 - 9]
    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 09/18/2026 Basic safety and essential performance   12-380 IEC 60601-2-37 Edition 3.0 2024-07 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 Clauses 201.17 and 202 (EMC Testing Only)
    Accreditation Granted 09/18/2026 Basic safety and essential performance   19-57 IEC 61326-2-6 Edition 4.0 2025-06 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
    Accreditation Granted 09/18/2026 Basic safety and essential performance   19-43 IEC 61326-2-6 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
    Excluding all except Clauses 201.17 and 202 (EMC Testing Only)
    Accreditation Granted 07/12/2024 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 09/18/2026 Basic safety and essential performance   6-423 IEC 60601-2-6 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
    Excluding all except Clauses 201.17 and 202 (EMC Testing Only)
    Accreditation Granted 09/18/2026 Basic safety and essential performance   17-22 IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
    Excluding all except Clauses 201.17 and 202 (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 09/18/2026 19-57
    		61326-2-6 Edition 4.0 2025-06
    Accredit Accreditation Granted 09/18/2026 6-423
    		60601-2-6 Edition 2.1 2016-04
    Excluding all except Clauses 201.17 and 202 (EMC Testing Only)
    Accredit Accreditation Granted 09/18/2026 17-22
    		60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION
    Excluding all except Clauses 201.17 and 202 (EMC Testing Only)
    Accredit Accreditation Granted 09/18/2026 12-380
    		60601-2-37 Edition 3.0 2024-07
    Excluding all except Clauses 201.17 and 202 (EMC Testing Only)
    Accredit Accreditation Granted 09/18/2026 19-43
    		61326-2-6 Edition 3.0 2020-10
    Excluding all except Clauses 201.17 and 202 (EMC Testing Only)
    Delete Administrative Deletion 07/18/2024 12-242
    		60601-2-57 Edition 1.0 2011-01
    Delete Administrative Deletion 07/18/2024 3-115
    		60601-2-34 Edition 3.0 2011-05
    Delete Administrative Deletion 07/18/2024 6-321
    		60601-2-52 Edition 1.0 2009-12
    Delete Administrative Deletion 07/18/2024 12-268
    		60601-2-22 Edition 3.1 2012-10
    Delete Administrative Deletion 07/18/2024 3-105
    		60601-2-25 Edition 2.0 2011-10
    Delete Administrative Deletion 07/18/2024 17-16
    		60601-2-10 Edition 2.1 2016-04
    Delete Administrative Deletion 07/18/2024 12-293
    		60601-2-37 Edition 2.1 2015
    Delete Administrative Deletion 07/18/2024 1-140
    		80601-2-55 Second edition 2018-02
    Delete Administrative Deletion 07/18/2024 3-126
    		60601-2-27 Edition 3.0 2011-03
    Delete Administrative Deletion 07/18/2024 1-138
    		80601-2-74 First edition 2017-05
    Delete Administrative Deletion 07/18/2024 1-146
    		80601-2-12 Second edition 2020-02
    Delete Administrative Deletion 07/18/2024 1-151
    		80601-2-70 Second edition 2020-11
    Delete Administrative Deletion 07/18/2024 6-389
    		60601-2-2 Edition 6.0 2017-03
    Delete Administrative Deletion 07/18/2024 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Delete Administrative Deletion 07/18/2024 9-114
    		60601-2-18: Edition 3.0 2009-08
    Delete Administrative Deletion 07/18/2024 1-139
    		80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
    Delete Administrative Deletion 07/18/2024 9-121
    		60601-2-16 Edition 5.0 2018-4
    Delete Administrative Deletion 07/18/2024 6-421
    		80601-2-56 Second edition 2017-03
    Delete Administrative Deletion 07/18/2024 4-262
    		80601-2-60 Edition 2.0 2019-06
    Delete Administrative Deletion 07/18/2024 3-155
    		60601-2-47 Edition 2.0 2012-02
    Delete Administrative Deletion 07/18/2024 3-123
    		80601-2-30: Edition 2.0 2018-03
    Delete Administrative Deletion 07/18/2024 5-131
    		60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
    Delete Administrative Deletion 07/18/2024 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Delete Administrative Deletion 07/18/2024 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Delete Administrative Deletion 07/18/2024 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Delete Administrative Deletion 07/18/2024 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Delete Administrative Deletion 07/18/2024 6-489
    		60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/17/2024 12-242
    		60601-2-57 Edition 1.0 2011-01
    Accredit Accreditation Granted 07/17/2024 3-115
    		60601-2-34 Edition 3.0 2011-05
    Accredit Accreditation Granted 07/17/2024 6-321
    		60601-2-52 Edition 1.0 2009-12
    Accredit Accreditation Granted 07/17/2024 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 07/17/2024 3-105
    		60601-2-25 Edition 2.0 2011-10
    Accredit Accreditation Granted 07/17/2024 17-16
    		60601-2-10 Edition 2.1 2016-04
    Accredit Accreditation Granted 07/17/2024 12-293
    		60601-2-37 Edition 2.1 2015
    Accredit Accreditation Granted 07/17/2024 1-140
    		80601-2-55 Second edition 2018-02
    Accredit Accreditation Granted 07/17/2024 3-126
    		60601-2-27 Edition 3.0 2011-03
    Accredit Accreditation Granted 07/17/2024 1-138
    		80601-2-74 First edition 2017-05
    Accredit Accreditation Granted 07/17/2024 1-146
    		80601-2-12 Second edition 2020-02
    Accredit Accreditation Granted 07/17/2024 1-151
    		80601-2-70 Second edition 2020-11
    Accredit Accreditation Granted 07/17/2024 6-389
    		60601-2-2 Edition 6.0 2017-03
    Accredit Accreditation Granted 07/17/2024 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/17/2024 9-114
    		60601-2-18: Edition 3.0 2009-08
    Accredit Accreditation Granted 07/17/2024 1-139
    		80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
    Accredit Accreditation Granted 07/17/2024 9-121
    		60601-2-16 Edition 5.0 2018-4
    Accredit Accreditation Granted 07/17/2024 6-421
    		80601-2-56 Second edition 2017-03
    Accredit Accreditation Granted 07/17/2024 4-262
    		80601-2-60 Edition 2.0 2019-06
    Accredit Accreditation Granted 07/17/2024 3-155
    		60601-2-47 Edition 2.0 2012-02
    Accredit Accreditation Granted 07/17/2024 3-123
    		80601-2-30: Edition 2.0 2018-03
    Accredit Accreditation Granted 07/17/2024 5-131
    		60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/17/2024 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/17/2024 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/17/2024 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/17/2024 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/17/2024 6-489
    		60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/02/2024 19-36
    		60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
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