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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: TÜV Rheinland (China) Ltd. [TL-97]
    Accreditation Status: Accreditation Granted - Start Date: 12/14/2021
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Jingming Zhao, jingming.zhao@tuv.com, Room 401, 4F,Block C, Building 1, No.139JingHai 3rd Road, Economic Technological Development Area Beijing CN 100176
     
    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 11/21/2025 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.
    Accreditation Granted 11/21/2025 Basic safety and essential performance   12-356 IEC 60601-2-22 Edition 4.0 2019-11 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    Accreditation Granted 11/21/2025 Basic safety and essential performance   6-489 IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
    Accreditation Granted 11/21/2025 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
    Accreditation Granted 11/21/2025 Basic safety and essential performance   12-336 IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    Accreditation Granted 11/21/2025 Basic safety and essential performance   12-339 IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    Accreditation Granted 11/21/2025 Basic safety and essential performance   12-348 IEC 60601-2-54 Edition 2.0 2022-09 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
    Accreditation Granted 11/21/2025 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
    Accreditation Granted 11/21/2025 Basic safety and essential performance   5-131 IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
    Accreditation Granted 11/21/2025 Basic safety and essential performance   6-438 IEC 80601-2-77 Edition 1.0 2019-07 Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
    Accreditation Granted 06/15/2022 Basic safety and essential performance   5-132 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    Accreditation Granted 12/15/2021 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 subclauses 201.10.101 Ultrasonic energy and 201.12 Accuracy of controls and instruments and protection against hazardous outputs
    Accreditation Granted 12/15/2021 Basic safety and essential performance   19-34 IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section
    Excluding subclauses: 10.5.3.2 Vicat softening, 11.7 Fluid pressure and leakage, 12.2 Ionizing radiation 12.3 Ultraviolet (UV) radiation 12.4 Microwave radiation 12.5 Sound level and ultrasonic pressure 13 Protection against Select to expand and show more non-recognition rationale text
    Accreditation Granted 12/15/2021 Basic safety and essential performance   6-389 IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    Excluding subclauses 201.8.5.5 Defibrillation-proof applied parts and 201.15.101.5 NE thermal performance
    Accreditation Granted 12/15/2021 Basic safety and essential performance   12-268 IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    Excluding 201.12.1.101 Laser output of working beam above 100 W
    Accreditation Granted 12/15/2021 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 subclauses 8.5.5 Defibrillation-proof applied parts, 9.6 Acoustic energy (including infra and ultrasound and vibration, 11.2.2 Medical equipment and systems used in conjunction with Select to expand and show more non-recognition rationale text
    Accreditation Granted 06/15/2022 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)]
    Excluding subclauses 8.5.5 Defibrillation-proof applied parts, 9.5.2 Cathode ray tubes, 9.6 Acoustic energy (including infra and ultrasound and vibration, 9.7 Pressure vessels and parts Select to expand and show more non-recognition rationale text
     
    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 11/21/2025 12-302
    		60601-2-44 Edition 3.2: 2016
    Accredit Accreditation Granted 11/21/2025 12-329
    		60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION
    Accredit Accreditation Granted 11/21/2025 12-336
    		60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 11/21/2025 12-339
    		60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION
    Accredit Accreditation Granted 11/21/2025 12-348
    		60601-2-54 Edition 2.0 2022-09
    Accredit Accreditation Granted 11/21/2025 12-356
    		60601-2-22 Edition 4.0 2019-11
    Accredit Accreditation Granted 11/21/2025 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Accredit Accreditation Granted 11/21/2025 3-155
    		60601-2-47 Edition 2.0 2012-02
    Accredit Accreditation Granted 11/21/2025 5-131
    		60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 11/21/2025 6-438
    		80601-2-77 Edition 1.0 2019-07
    Accredit Accreditation Granted 11/21/2025 6-489
    		60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
    Accredit Accreditation Granted 06/15/2022 19-46
    		ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
    Excluding subclauses 8.5.5 Defibrillation-proof applied parts, 9.5.2 Cathode ray tubes, 9.6 Acoustic energy (including infra and ultrasound and vibration, 9.7 Pressure vessels and parts Select to expand and show more text
    Accredit Accreditation Granted 06/15/2022 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 12/15/2021 12-268
    		60601-2-22 Edition 3.1 2012-10
    Excluding 201.12.1.101 Laser output of working beam above 100 W
    Accredit Accreditation Granted 12/15/2021 12-293
    		60601-2-37 Edition 2.1 2015
    Excluding subclauses 201.10.101 Ultrasonic energy and 201.12 Accuracy of controls and instruments and protection against hazardous outputs
    Accredit Accreditation Granted 12/15/2021 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Excluding subclauses: 10.5.3.2 Vicat softening, 11.7 Fluid pressure and leakage, 12.2 Ionizing radiation 12.3 Ultraviolet (UV) radiation 12.4 Microwave radiation 12.5 Sound level and ultrasonic pressure 13 Protection against Select to expand and show more text
    Accredit Accreditation Granted 12/15/2021 19-4
    		ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Excluding subclauses 8.5.5 Defibrillation-proof applied parts, 9.5.2 Cathode ray tubes, 9.6 Acoustic energy (including infra and ultrasound and vibration, 9.7 Pressure vessels and parts Select to expand and show more text
    Accredit Accreditation Granted 12/15/2021 5-89
    		60601-1-6 Edition 3.1 2013-10
    Accredit Accreditation Granted 12/15/2021 6-321
    		60601-2-52 Edition 1.0 2009-12
    Excluding subclauses 201.9.8.3.3 Dynamic forces due to loading from persons, 201.11.6.5 Ingress of water or particulate matter into medical equipment and systems, and Annex Select to expand and show more text
    Accredit Accreditation Granted 12/15/2021 6-389
    		60601-2-2 Edition 6.0 2017-03
    Excluding subclauses 201.8.5.5 Defibrillation-proof applied parts and 201.15.101.5 NE thermal performance
    Accredit Accreditation Granted 12/15/2021 9-114
    		60601-2-18: Edition 3.0 2009-08
    Excluding subclauses 8.5.5 Defibrillation-proof applied parts, 9.6 Acoustic energy (including infra and ultrasound and vibration, 11.2.2 Medical equipment and systems used in conjunction with Select to expand and show more text
    Delete Administrative Deletion 05/25/2023 19-4
    		ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Excluding subclauses 8.5.5 Defibrillation-proof applied parts, 9.5.2 Cathode ray tubes, 9.6 Acoustic energy (including infra and ultrasound and vibration, 9.7 Pressure vessels and parts Select to expand and show more text
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