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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: CSA America Testing & Certification LLC - Irvine [TL-47]
    Accreditation Status: Accreditation Granted - Start Date: 04/12/2021
    Accreditation Body Organization Name: International Acccreditation Service, Inc. (IAS)
    Test Lab Primary Contact: John Sena, john.sena@csagroup.org, 34 Bunsen Suite 150 Irvine CA US 92618
     
    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 04/12/2021 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 11/22/2022 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 10/11/2022 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 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   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 10/11/2022 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 04/12/2021 Basic safety and essential performance   3-102 IEC 60601-2-31 Edition 2.1 2011-09 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
    Accreditation Granted 04/12/2021 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
    Accreditation Granted 10/11/2022 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   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 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   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 10/11/2022 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)]
    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   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 04/12/2021 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 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 11/22/2022 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 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
     
    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 04/12/2021 1-105
    		80601-2-72 First edition 2015-04-11
    Delete Administrative Deletion 07/15/2022 1-138
    		80601-2-74 First edition 2017-05
    Accredit Accreditation Granted 04/12/2021 1-139
    		80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
    Accredit Accreditation Granted 04/12/2021 1-140
    		80601-2-55 Second edition 2018-02
    Delete Administrative Deletion 10/04/2022 1-141
    		80601-2-13 First edition 2011-08-11
    Accredit Accreditation Granted 10/11/2022 1-146
    		80601-2-12 Second edition 2020-02
    Accredit Accreditation Granted 10/11/2022 1-98
    		80601-2-12 First edition 2011-04-15
    Accredit Accreditation Granted 04/12/2021 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 04/12/2021 12-293
    		60601-2-37 Edition 2.1 2015
    Accredit Accreditation Granted 04/12/2021 17-16
    		60601-2-10 Edition 2.1 2016-04
    Accredit Accreditation Granted 04/12/2021 19-14
    		60601-1-11 Edition 2.0 2015-01
    Accredit Accreditation Granted 11/22/2022 19-15
    		60601-1-12 Edition 1.0 2014-06
    Accredit Accreditation Granted 04/12/2021 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 11/22/2022 19-37
    		60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 11/22/2022 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 10/11/2022 19-4
    		ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Accredit Accreditation Granted 10/11/2022 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 10/11/2022 19-47
    		HA60601-1-11:2015 [Including AMD1:2021]
    Accredit Accreditation Granted 11/22/2022 19-9
    		60601-1-10 Edition 1.1 2013-11
    Delete Administrative Deletion 07/14/2022 Closed Patch Sensitization 2-174
    		10993-10 Third Edition 2010-08-01
    Delete Administrative Deletion 07/14/2022 Dermal Irritation 2-174
    		10993-10 Third Edition 2010-08-01
    Delete Administrative Deletion 07/14/2022 Intracutaneous Reactivity Irritation 2-174
    		10993-10 Third Edition 2010-08-01
    Delete Administrative Deletion 07/14/2022 Guinea Pig Maximization Sensitization 2-174
    2-256     		10993-10 Third Edition 2010-08-01
    F720-17
    Accredit Accreditation Granted 04/12/2021 3-102
    		60601-2-31 Edition 2.1 2011-09
    Delete Administrative Deletion 05/23/2023 3-126
    		60601-2-27 Edition 3.0 2011-03
    Accredit Accreditation Granted 04/12/2021 4-262
    		80601-2-60 Edition 2.0 2019-06
    Accredit Accreditation Granted 04/12/2021 5-131
    		60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 5-76
    		60601-1-8 Edition 2.1 2012-11
    Accredit Accreditation Granted 04/12/2021 5-89
    		60601-1-6 Edition 3.1 2013-10
    Accredit Accreditation Granted 10/11/2022 6-389
    		60601-2-2 Edition 6.0 2017-03
    Accredit Accreditation Granted 04/12/2021 6-390
    		80601-2-35 Edition 2.1 2016-04
    Accredit Accreditation Granted 04/12/2021 9-114
    		60601-2-18: Edition 3.0 2009-08
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