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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  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here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: F2 Labs - Maryland [TL-21]
    Accreditation Status: Accreditation Granted - Start Date: 04/12/2021
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Ken Littell, klittell@f2labs.com, 26501 Ridge Rd. Unit B Damascus MD US 20872
     
    Scope of ASCA Accreditation
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    Exclusions
    Accreditation Granted 03/01/2024 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 07/28/2026 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 07/28/2026 Basic safety and essential performance   10-136 IEC 80601-2-58 Edition 3.0 2024-03 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-177 ISO 80601-2-74 Second edition 2021-07 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
    Accreditation Granted 07/28/2026 Basic safety and essential performance   17-19 ISO 80601-2-85 Edition 1.0 2021-03 Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
    Accreditation Granted 07/28/2026 Basic safety and essential performance   3-201 IEC 60601-2-31 Edition 3.0 2020-01 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 07/28/2026 Basic safety and essential performance   1-160 ISO 80601-2-84 First edition 2020-07 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-199 ISO 80601-2-70 Third edition 2025-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
    Accreditation Granted 07/28/2026 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 07/28/2026 Basic safety and essential performance   1-143 ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
    Accreditation Granted 07/28/2026 Basic safety and essential performance   6-512 IEC 60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
    Accreditation Granted 07/28/2026 Basic safety and essential performance   17-22 IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-144 ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-196 ISO 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
    Accreditation Granted 07/28/2026 Basic safety and essential performance   12-380 IEC 60601-2-37 Edition 3.0 2024-07 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
    Accreditation Granted 03/01/2024 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 03/01/2024 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 07/28/2026 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 07/28/2026 Basic safety and essential performance   12-381 IEC 60601-2-68 Edition 2.0 2025-02 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 07/28/2026 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 07/28/2026 Basic safety and essential performance   1-187 ISO 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-188 ISO 80601-2-84 Second edition 2023-11 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
    Accreditation Granted 07/28/2026 Basic safety and essential performance   6-510 IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
    Accreditation Granted 07/28/2026 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 04/12/2021 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 07/28/2026 Basic safety and essential performance   3-202 IEC 60601-2-34 Edition 4.0 2024-10 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
    Accreditation Granted 07/28/2026 Basic safety and essential performance   3-203 IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
    Accreditation Granted 07/28/2026 Basic safety and essential performance   6-508 IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
    Accreditation Granted 07/28/2026 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 07/28/2026 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 03/01/2024 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 04/12/2021 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 04/12/2021 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 04/12/2021 Basic safety and essential performance   6-405 IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
    Accreditation Granted 04/12/2021 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 07/28/2026 Basic safety and essential performance   12-355 IEC 60601-2-57 Edition 2.0 2023-07 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, cosmetic and aesthetic use
    Accreditation Granted 07/28/2026 Basic safety and essential performance   12-347 IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
    Accreditation Granted 07/28/2026 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 07/28/2026 Basic safety and essential performance   1-184 ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)].
    Accreditation Granted 04/12/2021 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
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-186 ISO 80601-2-80 Second edition 2024-08 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
    Accreditation Granted 07/28/2026 Basic safety and essential performance   12-356 IEC 60601-2-22 Edition 4.0 2019-11 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    Accreditation Granted 07/28/2026 Basic safety and essential performance   9-149 IEC 60601-2-39 Edition 3.0 2018-04 Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
    Accreditation Granted 07/28/2026 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 07/28/2026 Basic safety and essential performance   1-185 ISO 80601-2-79 Second edition 2024-08 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-141 ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-163 ISO 80601-2-72 Second edition 2023-06 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
    Accreditation Granted 07/28/2026 Basic safety and essential performance   10-126 IEC 80601-2-58 Edition 2.0 2014-09 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
    Accreditation Granted 03/01/2024 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 07/28/2026 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 03/01/2024 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)]
    Accreditation Granted 07/28/2026 Basic safety and essential performance   16-232 IEC 80601-2-78 Edition 1.0 2019-07 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-165 ISO 80601-2-13 Second edition 2022-04 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    Accreditation Granted 04/12/2021 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 03/01/2024 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)]
    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 07/28/2026 Basic safety and essential performance   1-152 ISO 80601-2-87 First edition 2021-04 Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
    Accreditation Granted 07/28/2026 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 07/28/2026 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 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   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 04/12/2021 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 07/28/2026 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 07/28/2026 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 03/01/2024 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 04/12/2021 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 07/28/2026 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 07/28/2026 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
    Accreditation Granted 07/28/2026 Basic safety and essential performance   12-281 IEC 60601-2-62 Edition 1.0 2013-07 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) 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 07/28/2026 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 04/12/2021 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)].
    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 07/28/2026 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 07/28/2026 Basic safety and essential performance   12-255 IEC 60601-2-11 Edition 3.0 2013-01 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
    Accreditation Granted 07/28/2026 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 04/12/2021 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 07/28/2026 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 07/28/2026 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 07/28/2026 Basic safety and essential performance   12-211 IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
    Accreditation Granted 07/28/2026 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 07/28/2026 Basic safety and essential performance   17-20 IEC 60601-2-40 Third edition 2024-12 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
    Accreditation Granted 07/28/2026 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 07/28/2026 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 07/28/2026 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 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 03/01/2024 Basic safety and essential performance   6-483 IEC 60601-2-35 Edition 2.0 2020-09 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
    Accreditation Granted 07/28/2026 Basic safety and essential performance   1-87 IEC 60601-2-23 Edition 3.0 2011-02 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring 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 08/03/2026 1-105
    		80601-2-72 First edition 2015-04-11
    Accredit Accreditation Granted 08/03/2026 1-139
    		80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
    Accredit Accreditation Granted 08/03/2026 1-140
    		80601-2-55 Second edition 2018-02
    Accredit Accreditation Granted 08/03/2026 1-141
    		80601-2-13 First edition 2011-08-11
    Accredit Accreditation Granted 08/03/2026 1-143
    		80601-2-79 First edition 2018-07
    Accredit Accreditation Granted 08/03/2026 1-144
    		80601-2-80 First edition 2018-07
    Accredit Accreditation Granted 08/03/2026 1-146
    		80601-2-12 Second edition 2020-02
    Accredit Accreditation Granted 08/03/2026 1-152
    		80601-2-87 First edition 2021-04
    Accredit Accreditation Granted 08/03/2026 1-160
    		80601-2-84 First edition 2020-07
    Accredit Accreditation Granted 08/03/2026 1-163
    		80601-2-72 Second edition 2023-06
    Accredit Accreditation Granted 08/03/2026 1-165
    		80601-2-13 Second edition 2022-04
    Accredit Accreditation Granted 08/03/2026 1-177
    		80601-2-74 Second edition 2021-07
    Accredit Accreditation Granted 08/03/2026 1-184
    		80601-2-55 Second edition 2018-02 [Including AMD1:2023]
    Accredit Accreditation Granted 08/03/2026 1-185
    		80601-2-79 Second edition 2024-08
    Accredit Accreditation Granted 08/03/2026 1-186
    		80601-2-80 Second edition 2024-08
    Accredit Accreditation Granted 08/03/2026 1-187
    		80601-2-12 Third edition 2023-11
    Accredit Accreditation Granted 08/03/2026 1-188
    		80601-2-84 Second edition 2023-11
    Accredit Accreditation Granted 08/03/2026 1-196
    		80601-2-90 First edition 2021-08
    Accredit Accreditation Granted 08/03/2026 1-199
    		80601-2-70 Third edition 2025-11
    Accredit Accreditation Granted 08/03/2026 1-87
    		60601-2-23 Edition 3.0 2011-02
    Accredit Accreditation Granted 08/03/2026 10-126
    		80601-2-58 Edition 2.0 2014-09
    Accredit Accreditation Granted 08/03/2026 10-136
    		80601-2-58 Edition 3.0 2024-03
    Accredit Accreditation Granted 08/03/2026 12-205
    		60601-2-5: Edition 3.0 2009-07
    Accredit Accreditation Granted 08/03/2026 12-211
    		60601-2-29 Edition 3.0 2008-06
    Accredit Accreditation Granted 08/03/2026 12-255
    		60601-2-11 Edition 3.0 2013-01
    Accredit Accreditation Granted 08/03/2026 12-272
    		60601-2-17 Edition 3.0 2013-11
    Accredit Accreditation Granted 08/03/2026 12-281
    		60601-2-62 Edition 1.0 2013-07
    Accredit Accreditation Granted 08/03/2026 12-294
    		60601-2-45 Edition 3.1 2015
    Accredit Accreditation Granted 08/03/2026 12-301
    		60601-2-8 Edition 2.1 b:2015
    Accredit Accreditation Granted 08/03/2026 12-302
    		60601-2-44 Edition 3.2: 2016
    Accredit Accreditation Granted 08/03/2026 12-309
    		60601-2-28 Edition 3.0 2017-06
    Accredit Accreditation Granted 08/03/2026 12-318
    		60601-2-64 Edition 1.0 2014-09
    Accredit Accreditation Granted 08/03/2026 12-319
    		60601-2-68 Edition 1.0 2014-09
    Accredit Accreditation Granted 08/03/2026 12-329
    		60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION
    Accredit Accreditation Granted 08/03/2026 12-339
    		60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION
    Accredit Accreditation Granted 08/03/2026 12-340
    		60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION
    Accredit Accreditation Granted 08/03/2026 12-347
    		60601-2-33 Edition 4.0 2022-08
    Accredit Accreditation Granted 08/03/2026 12-348
    		60601-2-54 Edition 2.0 2022-09
    Accredit Accreditation Granted 08/03/2026 12-351
    		60601-2-43 Edition 3.0 2022-12
    Accredit Accreditation Granted 08/03/2026 12-355
    		60601-2-57 Edition 2.0 2023-07
    Accredit Accreditation Granted 08/03/2026 12-356
    		60601-2-22 Edition 4.0 2019-11
    Accredit Accreditation Granted 08/03/2026 12-380
    		60601-2-37 Edition 3.0 2024-07
    Accredit Accreditation Granted 08/03/2026 12-381
    		60601-2-68 Edition 2.0 2025-02
    Accredit Accreditation Granted 08/03/2026 16-232
    		80601-2-78 Edition 1.0 2019-07
    Accredit Accreditation Granted 08/03/2026 17-19
    		80601-2-85 Edition 1.0 2021-03
    Accredit Accreditation Granted 08/03/2026 17-20
    		60601-2-40 Third edition 2024-12
    Accredit Accreditation Granted 08/03/2026 17-22
    		60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 08/03/2026 19-41
    		61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
    Accredit Accreditation Granted 08/03/2026 3-102
    		60601-2-31 Edition 2.1 2011-09
    Accredit Accreditation Granted 08/03/2026 3-115
    		60601-2-34 Edition 3.0 2011-05
    Accredit Accreditation Granted 08/03/2026 3-123
    		80601-2-30: Edition 2.0 2018-03
    Accredit Accreditation Granted 08/03/2026 3-201
    		60601-2-31 Edition 3.0 2020-01
    Accredit Accreditation Granted 08/03/2026 3-202
    		60601-2-34 Edition 4.0 2024-10
    Accredit Accreditation Granted 08/03/2026 3-203
    		80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION
    Accredit Accreditation Granted 08/03/2026 6-438
    		80601-2-77 Edition 1.0 2019-07
    Accredit Accreditation Granted 08/03/2026 6-450
    		60601-2-50 Edition 3.0 2020-09
    Accredit Accreditation Granted 08/03/2026 6-462
    		60601-2-20 Edition 3.0 2020-09
    Accredit Accreditation Granted 08/03/2026 6-508
    		80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 08/03/2026 6-510
    		80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION
    Accredit Accreditation Granted 08/03/2026 6-512
    		60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION
    Accredit Accreditation Granted 08/03/2026 9-119
    		60601-2-36 Edition 2.0 2014-04
    Accredit Accreditation Granted 08/03/2026 9-121
    		60601-2-16 Edition 5.0 2018-4
    Accredit Accreditation Granted 08/03/2026 9-149
    		60601-2-39 Edition 3.0 2018-04
    Accredit Accreditation Granted 04/22/2025 1-151
    		80601-2-70 Second edition 2020-11
    Accredit Accreditation Granted 04/22/2025 12-293
    		60601-2-37 Edition 2.1 2015
    Accredit Accreditation Granted 04/22/2025 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 04/22/2025 19-47
    		HA60601-1-11:2015 [Including AMD1:2021]
    Accredit Accreditation Granted 04/22/2025 19-49
    		60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/22/2025 6-461
    		60601-2-19 Edition 3.0 2020-09
    Accredit Accreditation Granted 04/22/2025 6-463
    		60601-2-21 Edition 3.0 2020-09
    Accredit Accreditation Granted 04/22/2025 6-483
    		60601-2-35 Edition 2.0 2020-09
    Accredit Accreditation Granted 04/22/2025 6-489
    		60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 1-102
    		80601-2-69 First edition 2014-07-15
    Accredit Accreditation Granted 04/12/2021 1-138
    		80601-2-74 First edition 2017-05
    Accredit Accreditation Granted 04/12/2021 1-148
    		80601-2-69 Second edition 2020-11
    Accredit Accreditation Granted 04/12/2021 12-242
    		60601-2-57 Edition 1.0 2011-01
    Accredit Accreditation Granted 04/12/2021 12-268
    		60601-2-22 Edition 3.1 2012-10
    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 04/12/2021 19-15
    		60601-1-12 Edition 1.0 2014-06
    Accredit Accreditation Granted 04/12/2021 19-16
    		HA60601-1-11:2015
    Accredit Accreditation Granted 04/12/2021 19-34
    		61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 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 04/12/2021 19-39
    		60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
    Accredit Accreditation Granted 04/12/2021 19-4
    		ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Accredit Accreditation Granted 04/12/2021 19-9
    		60601-1-10 Edition 1.1 2013-11
    Accredit Accreditation Granted 04/12/2021 3-105
    		60601-2-25 Edition 2.0 2011-10
    Accredit Accreditation Granted 04/12/2021 3-126
    		60601-2-27 Edition 3.0 2011-03
    Accredit Accreditation Granted 04/12/2021 3-155
    		60601-2-47 Edition 2.0 2012-02
    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 04/12/2021 6-321
    		60601-2-52 Edition 1.0 2009-12
    Accredit Accreditation Granted 04/12/2021 6-385
    		60601-2-19 Edition 2.1 2016-04
    Accredit Accreditation Granted 04/12/2021 6-386
    		60601-2-20 Edition 2.1 2016-04
    Accredit Accreditation Granted 04/12/2021 6-388
    		60601-2-21 Edition 2.1 2016-04
    Accredit Accreditation Granted 04/12/2021 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 6-405
    		80601-2-59 Edition 2.0 2017-09
    Accredit Accreditation Granted 04/12/2021 6-421
    		80601-2-56 Second edition 2017-03
    Accredit Accreditation Granted 04/12/2021 6-423
    		60601-2-6 Edition 2.1 2016-04
    Accredit Accreditation Granted 04/12/2021 9-114
    		60601-2-18: Edition 3.0 2009-08
    Delete Administrative Deletion 04/22/2025 1-148
    		80601-2-69 Second edition 2020-11
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