Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

ASCA-Accredited Testing Laboratories
  • Print
  • Share
  • E-mail
-

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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here

    • Learn more...


    Arrow buttons can be used to sort the table by each column heading.

    Super Search Devices@FDA
    510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
    CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
    		 

    Test Lab: TÜV SÜD Japan Ltd. Tokyo Testing Center [TL-116]
    Accreditation Status: Accreditation Granted - Start Date: 01/17/2023
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Toshiyuki Tamori, Toshiyuki.Tamori@tuvsud.com, NF Park Bldg, 4F 2-9-15 Futaba, Shinagawa-ku Tokyo JP 142-0043
     
    Scope of ASCA Accreditation
    export reports to excelExport to Excel
    		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 01/17/2023 Basic safety and essential performance   12-205 IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
    Accreditation Granted 01/17/2023 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
    Excluding clause 202
    Accreditation Granted 01/17/2023 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
    Excluding clause 202
    Accreditation Granted 01/17/2023 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)]
    Excluding subclause 202.6
    Accreditation Granted 01/17/2023 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 6.7.1.3, 10.5.3.2, 12.2.1, 12.4, 13.2.3
    Accreditation Granted 01/17/2023 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 clause 202
    Accreditation Granted 01/17/2023 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
    Accreditation Granted 01/17/2023 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 8.8.4.2 (rubber aging), 8.9.1.7, 9.5.2, 9.6.3, 10.1, 10.3, 11.2.2, 11.2.3, 11.4, 11.6.7, 11.7, 15.4.2 f), 15.4.3.4, 17, and Annexes G and L Note: Select to expand and show more non-recognition rationale text
    Accreditation Granted 01/17/2023 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
    Excluding subclause 201.12.4.4.101
    Accreditation Granted 01/17/2023 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
    Accreditation Granted 01/17/2023 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
    Accreditation Granted 01/17/2023 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
     
    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 01/17/2023 1-138
    		80601-2-74 First edition 2017-05
    Excluding clause 202
    Accredit Accreditation Granted 01/17/2023 1-138
    		80601-2-74 First edition 2017-05
    Excluding clause 202
    Accredit Accreditation Granted 01/17/2023 12-205
    		60601-2-5: Edition 3.0 2009-07
    Accredit Accreditation Granted 01/17/2023 12-205
    		60601-2-5: Edition 3.0 2009-07
    Accredit Accreditation Granted 01/17/2023 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 01/17/2023 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 01/17/2023 12-293
    		60601-2-37 Edition 2.1 2015
    Excluding clause 202
    Accredit Accreditation Granted 01/17/2023 12-293
    		60601-2-37 Edition 2.1 2015
    Excluding clause 202
    Accredit Accreditation Granted 01/17/2023 19-14
    		60601-1-11 Edition 2.0 2015-01
    Excluding subclauses 4.2, 10.1, 12
    Accredit Accreditation Granted 01/17/2023 19-14
    		60601-1-11 Edition 2.0 2015-01
    Excluding subclauses 4.2, 10.1, 12
    Accredit Accreditation Granted 01/17/2023 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Excluding subclauses 6.7.1.3, 10.5.3.2, 12.2.1, 12.4, 13.2.3
    Accredit Accreditation Granted 01/17/2023 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Excluding subclauses 6.7.1.3, 10.5.3.2, 12.2.1, 12.4, 13.2.3
    Accredit Accreditation Granted 01/17/2023 19-4
    		ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Excluding subclauses 8.8.4.2 (rubber aging), 8.9.1.7, 9.5.2, 9.6.3, 10.1, 10.3, 11.2.2, 11.2.3, 11.4, 11.6.7, 11.7, 15.4.2 f), 15.4.3.4, 17, and Annexes G and L Note: Select to expand and show more text
    Accredit Accreditation Granted 01/17/2023 19-46
    		ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
    Excluding subclauses 8.8.4.2 (rubber aging), 8.9.1.7, 9.5.2, 9.6.3, 10.1, 10.3, 11.2.2, 11.2.3, 11.4, 11.6.7, 11.7, 15.4.2 f), 15.4.3.4, 17, and Annexes G and L Note: Select to expand and show more text
    Accredit Accreditation Granted 01/17/2023 19-46
    		ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
    Excluding subclauses 8.8.4.2 (rubber aging), 8.9.1.7, 9.5.2, 9.6.3, 10.1, 10.3, 11.2.2, 11.2.3, 11.4, 11.6.7, 11.7, 15.4.2 f), 15.4.3.4, 17, and Annexes G and L Note: Select to expand and show more text
    Accredit Accreditation Granted 01/17/2023 3-105
    		60601-2-25 Edition 2.0 2011-10
    Excluding clause 202
    Accredit Accreditation Granted 01/17/2023 3-105
    		60601-2-25 Edition 2.0 2011-10
    Excluding clause 202
    Accredit Accreditation Granted 01/17/2023 3-126
    		60601-2-27 Edition 3.0 2011-03
    Excluding subclause 202.6
    Accredit Accreditation Granted 01/17/2023 3-126
    		60601-2-27 Edition 3.0 2011-03
    Excluding subclause 202.6
    Accredit Accreditation Granted 01/17/2023 3-155
    		60601-2-47 Edition 2.0 2012-02
    Accredit Accreditation Granted 01/17/2023 3-155
    		60601-2-47 Edition 2.0 2012-02
    Accredit Accreditation Granted 01/17/2023 4-262
    		80601-2-60 Edition 2.0 2019-06
    Accredit Accreditation Granted 01/17/2023 4-262
    		80601-2-60 Edition 2.0 2019-06
    Accredit Accreditation Granted 01/17/2023 5-76
    		60601-1-8 Edition 2.1 2012-11
    Accredit Accreditation Granted 01/17/2023 5-76
    		60601-1-8 Edition 2.1 2012-11
    Accredit Accreditation Granted 01/17/2023 5-89
    		60601-1-6 Edition 3.1 2013-10
    Accredit Accreditation Granted 01/17/2023 5-89
    		60601-1-6 Edition 3.1 2013-10
    Accredit Accreditation Granted 01/17/2023 6-385
    		60601-2-19 Edition 2.1 2016-04
    Excluding subclauses 201.11.1.2, 201.12.1.110, and 201.12.4.2.101
    Accredit Accreditation Granted 01/17/2023 6-385
    		60601-2-19 Edition 2.1 2016-04
    Excluding subclauses 201.11.1.2, 201.12.1.110, and 201.12.4.2.101
    Accredit Accreditation Granted 01/17/2023 6-386
    		60601-2-20 Edition 2.1 2016-04
    Excluding subclauses 201.11.1.2, 201.12.1.110, and 201.12.4.2.101
    Accredit Accreditation Granted 01/17/2023 6-386
    		60601-2-20 Edition 2.1 2016-04
    Excluding subclauses 201.11.1.2, 201.12.1.110, and 201.12.4.2.101
    Accredit Accreditation Granted 01/17/2023 6-388
    		60601-2-21 Edition 2.1 2016-04
    Excluding subclauses 201.12.1.110, 201.12.4.2.101, 202
    Accredit Accreditation Granted 01/17/2023 6-388
    		60601-2-21 Edition 2.1 2016-04
    Excluding subclauses 201.12.1.110, 201.12.4.2.101, 202
    Accredit Accreditation Granted 01/17/2023 9-114
    		60601-2-18: Edition 3.0 2009-08
    Accredit Accreditation Granted 01/17/2023 9-114
    		60601-2-18: Edition 3.0 2009-08
    Accredit Accreditation Granted 01/17/2023 9-121
    		60601-2-16 Edition 5.0 2018-4
    Excluding subclause 201.12.4.4.101
    Accredit Accreditation Granted 01/17/2023 9-121
    		60601-2-16 Edition 5.0 2018-4
    Excluding subclause 201.12.4.4.101
    -
    -