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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: TUV Rheinland North America, Inc - Boxborough [TL-158]
    Accreditation Status: Accreditation Granted - Start Date: 09/26/2025
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Gregory Chase, gchase@us.tuv.com, 400 Beaver Brook Road Boxborough MA US 01719
     
    Scope of ASCA Accreditation
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    Status
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    Biocompatibility
    Test
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    Sort by Standard Designation Number and Date [0 - 9]
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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 09/26/2025 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 09/26/2025 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 09/26/2025 Basic safety and essential performance   1-151 ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
    Accreditation Granted 09/26/2025 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 09/26/2025 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 09/26/2025 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 09/26/2025 Basic safety and essential performance   12-272 IEC 60601-2-17 Edition 3.0 2013-11 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
    Accreditation Granted 09/26/2025 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 09/26/2025 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
    Accreditation Granted 09/26/2025 Basic safety and essential performance   12-301 IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
    Accreditation Granted 09/26/2025 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
    Accreditation Granted 09/26/2025 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
    Accreditation Granted 09/26/2025 Basic safety and essential performance   12-318 IEC 60601-2-64 Edition 1.0 2014-09 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
    Accreditation Granted 09/26/2025 Basic safety and essential performance   12-319 IEC 60601-2-68 Edition 1.0 2014-09 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    Accreditation Granted 09/26/2025 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 09/26/2025 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
    Accreditation Granted 09/26/2025 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
    Accreditation Granted 09/26/2025 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
    Accreditation Granted 09/26/2025 Basic safety and essential performance   12-351 IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
    Accreditation Granted 09/26/2025 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 09/26/2025 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 09/26/2025 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 09/26/2025 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 09/26/2025 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
    Accreditation Granted 09/26/2025 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 09/26/2025 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 09/26/2025 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.
    Accreditation Granted 09/26/2025 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 09/26/2025 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 09/26/2025 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 09/26/2025 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 09/26/2025 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
    Accreditation Granted 09/26/2025 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 09/26/2025 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 09/26/2025 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 09/26/2025 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 09/26/2025 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 09/26/2025 Basic safety and essential performance   6-438 IEC 80601-2-77 Edition 1.0 2019-07 Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
    Accreditation Granted 09/26/2025 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 09/26/2025 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
    Accreditation Granted 09/26/2025 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
    Accreditation Granted 09/26/2025 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
    Accreditation Granted 09/26/2025 Basic safety and essential performance   6-489 IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
    Accreditation Granted 09/26/2025 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 09/26/2025 Basic safety and essential performance   9-119 IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
    Accreditation Granted 09/26/2025 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
     
    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 09/26/2025 1-139
    		80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
    Accredit Accreditation Granted 09/26/2025 1-148
    		80601-2-69 Second edition 2020-11
    Accredit Accreditation Granted 09/26/2025 1-151
    		80601-2-70 Second edition 2020-11
    Accredit Accreditation Granted 09/26/2025 12-205
    		60601-2-5: Edition 3.0 2009-07
    Accredit Accreditation Granted 09/26/2025 12-242
    		60601-2-57 Edition 1.0 2011-01
    Accredit Accreditation Granted 09/26/2025 12-268
    		60601-2-22 Edition 3.1 2012-10
    Accredit Accreditation Granted 09/26/2025 12-272
    		60601-2-17 Edition 3.0 2013-11
    Accredit Accreditation Granted 09/26/2025 12-293
    		60601-2-37 Edition 2.1 2015
    Accredit Accreditation Granted 09/26/2025 12-294
    		60601-2-45 Edition 3.1 2015
    Accredit Accreditation Granted 09/26/2025 12-301
    		60601-2-8 Edition 2.1 b:2015
    Accredit Accreditation Granted 09/26/2025 12-302
    		60601-2-44 Edition 3.2: 2016
    Accredit Accreditation Granted 09/26/2025 12-309
    		60601-2-28 Edition 3.0 2017-06
    Accredit Accreditation Granted 09/26/2025 12-318
    		60601-2-64 Edition 1.0 2014-09
    Accredit Accreditation Granted 09/26/2025 12-319
    		60601-2-68 Edition 1.0 2014-09
    Accredit Accreditation Granted 09/26/2025 12-329
    		60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 12-336
    		60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 12-339
    		60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 12-340
    		60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 12-348
    		60601-2-54 Edition 2.0 2022-09
    Accredit Accreditation Granted 09/26/2025 12-351
    		60601-2-43 Edition 3.0 2022-12
    Accredit Accreditation Granted 09/26/2025 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 19-36
    		60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 19-38
    		60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 19-41
    		61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
    Accredit Accreditation Granted 09/26/2025 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 09/26/2025 19-47
    		HA60601-1-11:2015 [Including AMD1:2021]
    Accredit Accreditation Granted 09/26/2025 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 3-105
    		60601-2-25 Edition 2.0 2011-10
    Accredit Accreditation Granted 09/26/2025 3-115
    		60601-2-34 Edition 3.0 2011-05
    Accredit Accreditation Granted 09/26/2025 3-123
    		80601-2-30: Edition 2.0 2018-03
    Accredit Accreditation Granted 09/26/2025 3-126
    		60601-2-27 Edition 3.0 2011-03
    Accredit Accreditation Granted 09/26/2025 3-155
    		60601-2-47 Edition 2.0 2012-02
    Accredit Accreditation Granted 09/26/2025 4-262
    		80601-2-60 Edition 2.0 2019-06
    Accredit Accreditation Granted 09/26/2025 5-131
    		60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 5-132
    		60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 6-321
    		60601-2-52 Edition 1.0 2009-12
    Accredit Accreditation Granted 09/26/2025 6-389
    		60601-2-2 Edition 6.0 2017-03
    Accredit Accreditation Granted 09/26/2025 6-423
    		60601-2-6 Edition 2.1 2016-04
    Accredit Accreditation Granted 09/26/2025 6-438
    		80601-2-77 Edition 1.0 2019-07
    Accredit Accreditation Granted 09/26/2025 6-450
    		60601-2-50 Edition 3.0 2020-09
    Accredit Accreditation Granted 09/26/2025 6-461
    		60601-2-19 Edition 3.0 2020-09
    Accredit Accreditation Granted 09/26/2025 6-462
    		60601-2-20 Edition 3.0 2020-09
    Accredit Accreditation Granted 09/26/2025 6-463
    		60601-2-21 Edition 3.0 2020-09
    Accredit Accreditation Granted 09/26/2025 6-489
    		60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
    Accredit Accreditation Granted 09/26/2025 9-114
    		60601-2-18: Edition 3.0 2009-08
    Accredit Accreditation Granted 09/26/2025 9-119
    		60601-2-36 Edition 2.0 2014-04
    Accredit Accreditation Granted 09/26/2025 9-121
    		60601-2-16 Edition 5.0 2018-4
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