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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: TUV-SUD (China), Guangzhou Branch [TL-133]
    Accreditation Status: Accreditation Granted - Start Date: 05/03/2024
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Vivian Li, vivian.li1@tuvsud.com, D1 Building, No.63, Chuangqi Road, Shilou, Panyu District Guangzhou CN
     
    Scope of ASCA Accreditation
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    		Return to list of Testing Labs
    Status
    Status
    Date
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    Sort by Standard Designation Number and Date [9 - 0]
    Category
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    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 07/22/2026 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
    Accreditation Granted 07/22/2026 Basic safety and essential performance   1-143 ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
    Accreditation Granted 07/22/2026 Basic safety and essential performance   1-144 ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
    Accreditation Granted 07/22/2026 Basic safety and essential performance   1-148 ISO 80601-2-69 Second edition 2020-11 Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
    Accreditation Granted 07/22/2026 Basic safety and essential performance   1-160 ISO 80601-2-84 First edition 2020-07 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
    Accreditation Granted 07/22/2026 Basic safety and essential performance   1-177 ISO 80601-2-74 Second edition 2021-07 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
    Accreditation Granted 07/22/2026 Basic safety and essential performance   1-184 ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)].
    Accreditation Granted 07/22/2026 Basic safety and essential performance   1-187 ISO 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    Accreditation Granted 07/22/2026 Basic safety and essential performance   1-196 ISO 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
    Accreditation Granted 07/22/2026 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 07/22/2026 Basic safety and essential performance   12-355 IEC 60601-2-57 Edition 2.0 2023-07 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
    Accreditation Granted 07/22/2026 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 07/22/2026 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
    Accreditation Granted 07/22/2026 Basic safety and essential performance   19-41 ANSI, UL 61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
    Accreditation Granted 07/22/2026 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)]
    Accreditation Granted 07/22/2026 Basic safety and essential performance   19-47 AAMI, ANSI HA60601-1-11:2015 [Including AMD1:2021] Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
    Accreditation Granted 07/22/2026 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 07/22/2026 Basic safety and essential performance   6-510 IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
    Accreditation Granted 05/23/2025 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 05/13/2024 Basic safety and essential performance   1-138 ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
    Accreditation Granted 05/13/2024 Basic safety and essential performance   1-139 ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
    Accreditation Granted 05/13/2024 Basic safety and essential performance   1-140 ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    Accreditation Granted 05/13/2024 Basic safety and essential performance   1-146 ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    Accreditation Granted 05/13/2024 Basic safety and essential performance   1-151 ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
    Accreditation Granted 05/13/2024 Basic safety and essential performance   12-242 IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
    Accreditation Granted 05/13/2024 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
    Accreditation Granted 05/13/2024 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
    Accreditation Granted 05/13/2024 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
    Accreditation Granted 05/13/2024 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
    Accreditation Granted 05/13/2024 Basic safety and essential performance   19-38 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
    Accreditation Granted 05/13/2024 Basic safety and essential performance   19-39 IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
    Accreditation Granted 05/13/2024 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 05/13/2024 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
    Accreditation Granted 05/13/2024 Basic safety and essential performance   3-115 IEC 60601-2-34 Edition 3.0 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
    Accreditation Granted 05/13/2024 Basic safety and essential performance   3-123 IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    Accreditation Granted 05/13/2024 Basic safety and essential performance   3-126 IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
    Accreditation Granted 05/13/2024 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 05/13/2024 Basic safety and essential performance   4-262 IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
    Accreditation Granted 05/13/2024 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 05/13/2024 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 05/13/2024 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
    Accreditation Granted 05/13/2024 Basic safety and essential performance   6-421 ISO 80601-2-56 Second edition 2017-03 [Including AMD1:2018] Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
    Accreditation Granted 05/13/2024 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 05/13/2024 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
    Accreditation Granted 05/13/2024 Basic safety and essential performance   9-121 IEC 60601-2-16 Edition 5.0 2018-4 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
     
    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 07/22/2026 1-143
    		80601-2-79 First edition 2018-07
    Accredit Accreditation Granted 07/22/2026 1-144
    		80601-2-80 First edition 2018-07
    Accredit Accreditation Granted 07/22/2026 1-148
    		80601-2-69 Second edition 2020-11
    Accredit Accreditation Granted 07/22/2026 1-160
    		80601-2-84 First edition 2020-07
    Accredit Accreditation Granted 07/22/2026 1-177
    		80601-2-74 Second edition 2021-07
    Accredit Accreditation Granted 07/22/2026 1-184
    		80601-2-55 Second edition 2018-02 [Including AMD1:2023]
    Accredit Accreditation Granted 07/22/2026 1-187
    		80601-2-12 Third edition 2023-11
    Accredit Accreditation Granted 07/22/2026 1-196
    		80601-2-90 First edition 2021-08
    Accredit Accreditation Granted 07/22/2026 12-336
    		60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/22/2026 12-355
    		60601-2-57 Edition 2.0 2023-07
    Accredit Accreditation Granted 07/22/2026 12-356
    		60601-2-22 Edition 4.0 2019-11
    Accredit Accreditation Granted 07/22/2026 12-380
    		60601-2-37 Edition 3.0 2024-07
    Accredit Accreditation Granted 07/22/2026 17-22
    		60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 07/22/2026 19-41
    		61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
    Accredit Accreditation Granted 07/22/2026 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 07/22/2026 19-47
    		HA60601-1-11:2015 [Including AMD1:2021]
    Accredit Accreditation Granted 07/22/2026 6-438
    		80601-2-77 Edition 1.0 2019-07
    Accredit Accreditation Granted 07/22/2026 6-510
    		80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION
    Accredit Accreditation Granted 11/21/2025 19-36
    		60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
    Accredit Accreditation Granted 05/13/2024 1-115
    		80601-2-70 First Edition 2015-01-15
    Accredit Accreditation Granted 05/13/2024 1-138
    		80601-2-74 First edition 2017-05
    Accredit Accreditation Granted 05/13/2024 1-139
    		80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
    Accredit Accreditation Granted 05/13/2024 1-140
    		80601-2-55 Second edition 2018-02
    Accredit Accreditation Granted 05/13/2024 1-146
    		80601-2-12 Second edition 2020-02
    Accredit Accreditation Granted 05/13/2024 1-151
    		80601-2-70 Second edition 2020-11
    Accredit Accreditation Granted 05/13/2024 12-242
    		60601-2-57 Edition 1.0 2011-01
    Accredit Accreditation Granted 05/13/2024 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 05/13/2024 12-293
    		60601-2-37 Edition 2.1 2015
    Accredit Accreditation Granted 05/13/2024 17-16
    		60601-2-10 Edition 2.1 2016-04
    Accredit Accreditation Granted 05/13/2024 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 05/13/2024 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 05/13/2024 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 05/13/2024 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Accredit Accreditation Granted 05/13/2024 3-105
    		60601-2-25 Edition 2.0 2011-10
    Accredit Accreditation Granted 05/13/2024 3-115
    		60601-2-34 Edition 3.0 2011-05
    Accredit Accreditation Granted 05/13/2024 3-123
    		80601-2-30: Edition 2.0 2018-03
    Accredit Accreditation Granted 05/13/2024 3-126
    		60601-2-27 Edition 3.0 2011-03
    Accredit Accreditation Granted 05/13/2024 3-155
    		60601-2-47 Edition 2.0 2012-02
    Accredit Accreditation Granted 05/13/2024 4-262
    		80601-2-60 Edition 2.0 2019-06
    Accredit Accreditation Granted 05/13/2024 5-131
    		60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 05/13/2024 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 05/13/2024 6-321
    		60601-2-52 Edition 1.0 2009-12
    Accredit Accreditation Granted 05/13/2024 6-389
    		60601-2-2 Edition 6.0 2017-03
    Accredit Accreditation Granted 05/13/2024 6-421
    		80601-2-56 Second edition 2017-03
    Accredit Accreditation Granted 05/13/2024 6-489
    		60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
    Accredit Accreditation Granted 05/13/2024 9-114
    		60601-2-18: Edition 3.0 2009-08
    Accredit Accreditation Granted 05/13/2024 9-121
    		60601-2-16 Edition 5.0 2018-4
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