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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  • As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.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: Eurofins Electrical Testing Service (Shanghai) Co., Ltd. [TL-122]
    Accreditation Status: Accreditation Granted - Date: 11/14/2023
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: June Fan, june.fan@cpt.eurofinscn.com, Building 18, No. 2168 Chenghang Highway Minhang District Shanghai CN
     
    Scope of ASCA Accreditation 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
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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 11/14/2023 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
    Excluding subclauses 201.12.1.101 / Humidification output 201.12.1.105 / Dynamic temperature stability
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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
    Excluding subclause 201.12 / Accuracy of controls and instruments and protection against hazardous outputs
    Accreditation Granted 11/14/2023 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
    Excluding subclauses 201.9.101 / Additional requirements for suction procedures 201.12.1.101 / Volume-control inflation-type 201.12.1.102 / Pressure-control inflation-type 201.12.1.105 / Response of the ventilator to an increase in Select to expand and show more non-recognition rationale text
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 Basic safety and essential performance   12-294 IEC 60601-2-45 Edition 3.1 2015 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
    Excluding subclauses 201.8.5.4.101 / Stator and stator circuit dielectric strength testing 201.8.8.3 / Dielectric strength 201.9.2.101 / Three dimensional localization and interventional mammographic guidance 203 / Radiation Select to expand and show more non-recognition rationale text
    Accreditation Granted 11/14/2023 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
    Excluding subclauses 201.8.8.3 / Dielectric strength 203 / General requirements for RADIATION protection in diagnostic X-ray equipment
    Accreditation Granted 11/14/2023 Basic safety and essential performance   12-309 IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    Excluding subclauses 201.8.8.3 / Dielectric strength 201.12.4.5.2 / Diagnostic X-RAY EQUIPMENT 203 / RADIATION protection in diagnostic X-RAY EQUIPMENT
    Accreditation Granted 11/14/2023 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
    Excluding subclauses 201.8.5.4.101 / Stator and stator circuit dielectric strength testing 201.8.8.3 / Dielectric strength 203 / Radiation protection in diagnostic X-ray equipment
    Accreditation Granted 11/14/2023 Basic safety and essential performance   12-340 IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
    Excluding subclauses 201.8.8.3 Dielectric strength 203 Radiation protection in diagnostic X-ray equipment
    Accreditation Granted 11/14/2023 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
    Excluding subclauses 201.8.5.4.101 / Stator and stator circuit dielectric strength testing 201.8.8.3 / Dielectric strength 203 / Radiation protection in diagnostic X-ray equipment
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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 9.5 / flammable liquid 10.5.3(2) / Vi cat softening test 12.2./ Ionizi ng radiation test 12.4 / Microwave radiation test 12.5 / Sonic and ultrasonic pressure 13.2.3 Select to expand and show more non-recognition rationale text
    Accreditation Granted 11/14/2023 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 11/14/2023 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 11/14/2023 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
    Excluding subclauses 9.5 / flammable liquid 10.5.3(2) / Vi cat softening test 12.2./ Ionizi ng radiation test 12.4 / Microwave radiation test 12.5 / Sonic and ultrasonic pressure 13.2.3 Select to expand and show more non-recognition rationale text
    Accreditation Granted 11/14/2023 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 subclauses 9.6.2.1 / Audible acoustic energy 8.8.4.2 Resistance to environmental stress 10.1.1 ME EQUIPMENT not intended to produce diagnostic or therapeutic X-radiation 10.3 / Microwave radiation 11.2.2.1 Select to expand and show more non-recognition rationale text
    Accreditation Granted 11/14/2023 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 11/14/2023 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.
    Excluding subclauses 9.6.2.1 / Audible acoustic energy 8.8.4.2 Resistance to environmental stress 10.1.1 ME EQUIPMENT not intended to produce diagnostic or therapeutic X-radiation 10.3 / Microwave radiation 11.2.2.1 Select to expand and show more non-recognition rationale text
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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
    Excluding subclauses 201.12.1.101 / Accuracy of pressure measurements 208.6.6.2.101 / Physiological ALARM CONDITIONS, ALARM LIMITS and delay time of physiological ALARM SIGNALS
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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)]
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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 11/14/2023 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 11/14/2023 Basic safety and essential performance   6-321 IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
    Excluding subclause 201.11.6.6.101 / Machine washable medical bed
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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)].
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
    Accreditation Granted 11/14/2023 Basic safety and essential performance   6-461 IEC 60601-2-19 Edition 3.0 2020-09 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    Excluding subclauses 201.12.1.109 / Accuracy of indication of relative humidity 201.12.1.110 / Oxygen control 201.12.1.111 / Air velocity 201.12.4.2.101 / CO2-concentration
    Accreditation Granted 11/14/2023 Basic safety and essential performance   6-462 IEC 60601-2-20 Edition 3.0 2020-09 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
    Excluding subclauses 201.12.1.109 / Accuracy of indication of relative humidity 201.12.1.110 / Oxygen control 201.12.1.111 / Air velocity 201.12.1.113 / Provision of oxygen 201.12.4.2.101 / CO2 concentration
    Accreditation Granted 11/14/2023 Basic safety and essential performance   6-463 IEC 60601-2-21 Edition 3.0 2020-09 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    Excluding subclauses 201.12.1.104 / Oxygen control 201.12.4.2.101 / CO2 concentration
    Accreditation Granted 11/14/2023 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
    Please see the exclusions listed for 60601-1
     
    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
    Transition Inactive 12/17/2023 1-102
    		 80601-2-69 First edition 2014-07-15
    Please see the exclusions listed for 60601-1
    Transition Inactive 12/17/2023 12-310
    		 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION
    Excluding subclauses 201.8.5.4.101 / Stator and stator circuit dielectric strength testing 201.8.8.3 / Dielectric strength 203 / Radiation protection in diagnostic X-ray equipment
    Transition Inactive 12/17/2023 12-311
    		 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION
    Excluding subclauses 201.8.8.3 Dielectric strength 203 Radiation protection in diagnostic X-ray equipment
    Transition Inactive 12/17/2023 12-317
    		 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION
    Please see the exclusions listed for 60601-1
    Transition Inactive 12/17/2023 19-14
    		 60601-1-11 Edition 2.0 2015-01
    Transition Inactive 12/17/2023 19-15
    		 60601-1-12 Edition 1.0 2014-06
    Transition Inactive 12/17/2023 19-16
    		 HA60601-1-11:2015
    Transition Inactive 12/17/2023 19-4
    		 ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Excluding subclauses 9.6.2.1 / Audible acoustic energy 8.8.4.2 Resistance to environmental stress 10.1.1 ME EQUIPMENT not intended to produce diagnostic or therapeutic X-radiation 10.3 / Microwave radiation 11.2.2.1 Select to expand and show more text
    Transition Inactive 12/17/2023 5-76
    		 60601-1-8 Edition 2.1 2012-11
    Transition Inactive 12/17/2023 5-89
    		 60601-1-6 Edition 3.1 2013-10
    Transition Inactive 12/17/2023 6-385
    		 60601-2-19 Edition 2.1 2016-04
    Excluding subclauses 201.12.1.109 / Accuracy of indication of relative humidity 201.12.1.110 / Oxygen control 201.12.1.111 / Air velocity 201.12.4.2.101 / CO2-concentration
    Transition Inactive 12/17/2023 6-386
    		 60601-2-20 Edition 2.1 2016-04
    Excluding subclauses 201.12.1.109 / Accuracy of indication of relative humidity 201.12.1.110 / Oxygen control 201.12.1.111 / Air velocity 201.12.1.113 / Provision of oxygen 201.12.4.2.101 / CO2 concentration
    Transition Inactive 12/17/2023 6-387
    		 60601-2-50 Edition 2.1 2016-04
    Please see the exclusions listed for 60601-1
    Transition Inactive 12/17/2023 6-388
    		 60601-2-21 Edition 2.1 2016-04
    Excluding subclauses 201.12.1.104 / Oxygen control 201.12.4.2.101 / CO2 concentration
    Transition Inactive 07/09/2023 1-98
    		 80601-2-12 First edition 2011-04-15
    Excluding subclauses 201.9.101 / Additional requirements for suction procedures 201.12.1.101 / Volume-control inflation-type 201.12.1.102 / Pressure-control inflation-type 201.12.1.105 / Response of the ventilator to an increase in Select to expand and show more text
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