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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.
  • As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.

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    Test Lab: Criterion, a Biotex, Inc. service [TL-124]
    Accreditation Status: Accreditation Granted - Date: 01/09/2024
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Wade Munsch, criterion@biotexmedical.com, 114 Holmes Rd. Houston TX US 77045
     
    Scope of ASCA Accreditation Return to list of Testing Labs
    Status
    Status
    Date
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    Category
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    Biocompatibility
    Test
    Method
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    Recognition
    Number
    Sort by Standard Designation Number and Date [0 - 9]
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    Standards
    Development
    Organization
    Standard Designation
    Number and Date
    Title
    Exclusions
    Accreditation Granted 01/09/2024 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 01/09/2024 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 01/09/2024 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
    Exclusing subclauses 4.2.2.1 Continuous Operating Conditions (Pressure Only) 10.1.2 Requirements for mechanical strength for fixed or permanently installed ME Equipment intended for use in a road ambulance Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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 8.5.5.1 Defibrillation Protection 8.5.5.2 Energy Reduction Test 8.8.4.2 Resistance to Environmental Stress (Natural Rubber Latex Test Only) 9.6.2.1 Audible Acoustic Energy 9.6.3 Hand-transmitted Vibration 10.1 X-radiation 11.2.2.1 Risk of Fire in an Oxygen Rich Environment 11.2.3 Single Fault Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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 subclauses 4.2.3.1 Continuous Operating Conditions (Pressure Only) 4.2.3.2 Environmental shock to Transit-Operable ME Equipment 10.1.2 Requirements for Mechanical Strength for NON-Transit-Operable ME Equipment / Shock and Vibration 10.1.3 Requirements for Mechanical Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/09/2024 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
    Excluding subclause 6.3.3.2 Volume of Auditory Alarm Signals and Information Signals
    Accreditation Granted 01/09/2024 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 01/09/2024 Basic safety and essential performance   6-421 ISO 80601-2-56 Second edition 2017-03 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 01/09/2024 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
     
    Scope History
    Action Type
    ASCA Status
    Effective
    Start Date
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    Biocompatibility
    Test Method
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    Recognition
    Number
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    Designation Number
    Exclusions
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