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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: Intertek Testing Services NA, Inc. - Lake Forest [TL-34]
    Accreditation Status: Accreditation Granted - Start Date: 04/12/2021
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Yaqing Liu, yaqing.liu@intertek.com, 25800 Commercentre Drive Suite 200 Lake Forest CA US 92630
     
    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 06/18/2026 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 06/18/2026 Basic safety and essential performance   1-163 ISO 80601-2-72 Second edition 2023-06 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
    Accreditation Granted 06/18/2026 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 06/18/2026 Basic safety and essential performance   1-185 ISO 80601-2-79 Second edition 2024-08 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
    Accreditation Granted 06/18/2026 Basic safety and essential performance   1-186 ISO 80601-2-80 Second edition 2024-08 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
    Accreditation Granted 06/18/2026 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 06/18/2026 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 06/18/2026 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 06/18/2026 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
    Accreditation Granted 06/18/2026 Basic safety and essential performance   3-203 IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
    Accreditation Granted 09/20/2024 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)]
    Excluding section 4.2.2, Excluding shock and vibration
    Accreditation Granted 09/20/2024 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 09/20/2024 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 09/20/2024 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 09/20/2024 Basic safety and essential performance   19-37 IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
    Accreditation Granted 09/20/2024 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
    Excluding section 4.2.2, Excluding shock and vibration
    Accreditation Granted 09/20/2024 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 09/20/2024 Basic safety and essential performance   6-450 IEC 60601-2-50 Edition 3.0 2020-09 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
    Accreditation Granted 09/20/2024 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 04/12/2021 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 Vicat Softening and CRT/High Vacuum
    Accreditation Granted 04/12/2021 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
    Accreditation Granted 04/12/2021 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
    Accreditation Granted 04/12/2021 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
    Accreditation Granted 04/12/2021 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
    Accreditation Granted 04/12/2021 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 04/12/2021 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 04/12/2021 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 04/12/2021 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 04/12/2021 Basic safety and essential performance   1-105 ISO 80601-2-72 First edition 2015-04-11 Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
    Accreditation Granted 04/12/2021 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 04/12/2021 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
    Accreditation Granted 05/08/2023 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 Clause 9.5 Expelled Parts; Clauses 11.4, 11.5 Flammable Gases and Oxygen Bomb
    Accreditation Granted 05/08/2023 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 04/12/2021 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
    Accreditation Granted 04/12/2021 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
    Accreditation Granted 04/12/2021 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 04/12/2021 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 04/12/2021 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 04/12/2021 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 04/12/2021 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 04/12/2021 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
     
    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 06/26/2026 1-146
    		80601-2-12 Second edition 2020-02
    Accredit Accreditation Granted 06/26/2026 1-163
    		80601-2-72 Second edition 2023-06
    Accredit Accreditation Granted 06/26/2026 1-177
    		80601-2-74 Second edition 2021-07
    Accredit Accreditation Granted 06/26/2026 1-185
    		80601-2-79 Second edition 2024-08
    Accredit Accreditation Granted 06/26/2026 1-186
    		80601-2-80 Second edition 2024-08
    Accredit Accreditation Granted 06/26/2026 1-187
    		80601-2-12 Third edition 2023-11
    Accredit Accreditation Granted 06/26/2026 12-355
    		60601-2-57 Edition 2.0 2023-07
    Accredit Accreditation Granted 06/26/2026 12-356
    		60601-2-22 Edition 4.0 2019-11
    Accredit Accreditation Granted 06/26/2026 17-22
    		60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 06/26/2026 3-203
    		80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/20/2024 1-148
    		80601-2-69 Second edition 2020-11
    Accredit Accreditation Granted 09/20/2024 12-336
    		60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/20/2024 19-37
    		60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/20/2024 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/20/2024 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/20/2024 19-47
    		HA60601-1-11:2015 [Including AMD1:2021]
    excluding section 4.2.2, excluding shock and vibration
    Accredit Accreditation Granted 09/20/2024 5-131
    		60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/20/2024 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/20/2024 6-450
    		60601-2-50 Edition 3.0 2020-09
    Accredit Accreditation Granted 05/08/2023 19-36
    		60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
    Accredit Accreditation Granted 05/08/2023 19-46
    		ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
    Excluding Clause 9.5 Expelled Parts; Clauses 11.4, 11.5 Flammable Gases and Oxygen Bomb
    Accredit Accreditation Granted 04/12/2021 1-102
    		80601-2-69 First edition 2014-07-15
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 1-105
    		80601-2-72 First edition 2015-04-11
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 1-138
    		80601-2-74 First edition 2017-05
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 1-139
    		80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 1-140
    		80601-2-55 Second edition 2018-02
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 1-143
    		80601-2-79 First edition 2018-07
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 1-144
    		80601-2-80 First edition 2018-07
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 1-98
    		80601-2-12 First edition 2011-04-15
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 12-242
    		60601-2-57 Edition 1.0 2011-01
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 12-268
    		60601-2-22 Edition 3.1 2012-10
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 12-269
    		60601-1-3 Edition 2.1 2013-04
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 17-16
    		60601-2-10 Edition 2.1 2016-04
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 19-14
    		60601-1-11 Edition 2.0 2015-01
    Excluding Shock and Vibration and Sections 4.2.2, 10.1.2, 10.1.3
    Accredit Accreditation Granted 04/12/2021 19-15
    		60601-1-12 Edition 1.0 2014-06
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 19-16
    		HA60601-1-11:2015
    Excluding Shock and Vibration and Sections 4.2.2, 10.1.2, 10.1.3
    Accredit Accreditation Granted 04/12/2021 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Excluding Vicat Softening and CRT/High Vacuum
    Accredit Accreditation Granted 04/12/2021 19-4
    		ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Excluding Clause 9.5 Expelled Parts; Clauses 11.4, 11.5 Flammable Gases and Oxygen Bomb
    Accredit Accreditation Granted 04/12/2021 19-8
    		60601-1-2 Edition 4.0 2014-02
    Accredit Accreditation Granted 04/12/2021 19-9
    		60601-1-10 Edition 1.1 2013-11
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 3-105
    		60601-2-25 Edition 2.0 2011-10
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 3-115
    		60601-2-34 Edition 3.0 2011-05
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 3-123
    		80601-2-30: Edition 2.0 2018-03
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 3-126
    		60601-2-27 Edition 3.0 2011-03
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 4-262
    		80601-2-60 Edition 2.0 2019-06
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 5-76
    		60601-1-8 Edition 2.1 2012-11
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 5-89
    		60601-1-6 Edition 3.1 2013-10
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 6-387
    		60601-2-50 Edition 2.1 2016-04
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 6-389
    		60601-2-2 Edition 6.0 2017-03
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 6-421
    		80601-2-56 Second edition 2017-03
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 6-423
    		60601-2-6 Edition 2.1 2016-04
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 9-114
    		60601-2-18: Edition 3.0 2009-08
    Excluding Shock and Vibration
    Accredit Accreditation Granted 04/12/2021 9-121
    		60601-2-16 Edition 5.0 2018-4
    Excluding Shock and Vibration
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