ASCA-Accredited Testing Laboratories

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As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.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: TÜV Rheinland (China) Ltd. [TL-97]

Accreditation Status: Accreditation Granted - Date: 12/14/2021

Accreditation Body Organization Name: A2LA

Test Lab Primary Contact: Jingming Zhao, jingming.zhao@tuv.com, Room 401, 4F,Block C, Building 1, No.139JingHai 3rd Road, Economic Technological Development Area Beijing CN 100176

Status	Status Date	Category	Biocompatibility Test Method	Recognition Number	Standards Development Organization	Standard Designation Number and Date	Title	Exclusions
Accreditation Granted	12/15/2021	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	Excluding 201.12.1.101 Laser output of working beam above 100 W
Accreditation Granted	12/15/2021	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 subclauses 201.10.101 Ultrasonic energy and 201.12 Accuracy of controls and instruments and protection against hazardous outputs
Accreditation Granted	12/15/2021	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	Excluding subclauses: 10.5.3.2 Vicat softening, 11.7 Fluid pressure and leakage, 12.2 Ionizing radiation 12.3 Ultraviolet (UV) radiation 12.4 Microwave radiation 12.5 Sound level and ultrasonic pressure 13 Protection against liberated gases and substances, explosion and implosion
Accreditation Granted	06/15/2022	Basic safety and essential performance		19-46	ANSI, AAMI	ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]	Excluding subclauses 8.5.5 Defibrillation-proof applied parts, 9.5.2 Cathode ray tubes, 9.6 Acoustic energy (including infra and ultrasound and vibration, 9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure, 9.8.3.3 Dynamic forces due to loading from persons, 11.2.2 Medical equipment and systems used in conjunction with oxygen rich environments, 11.4 Medical equipment and systems intended for sue with flammable anesthetic, 11.6.5 Ingress of water or particulate matter into medical equipment and systems, 11.6.7 Sterilization of medical equipment and systems, 11.6.8 Compatibility with substances used with medical equipment, 12.4.5 Diagnostic or therapeutic radiation, 13.2.13.3 Medical equipment with motors, 14 Programmable electrical medical systems (PEMS) NOTE: These exclusions also apply to other collaterals and particulars in the ASCA scope of accreditation)
Accreditation Granted	06/15/2022	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	12/15/2021	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 subclauses 201.9.8.3.3 Dynamic forces due to loading from persons, 201.11.6.5 Ingress of water or particulate matter into medical equipment and systems, and Annex BB.2.2 Effect of impacts to the mattress support platform
Accreditation Granted	12/15/2021	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	Excluding subclauses 201.8.5.5 Defibrillation-proof applied parts and 201.15.101.5 NE thermal performance
Accreditation Granted	12/15/2021	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	Excluding subclauses 8.5.5 Defibrillation-proof applied parts, 9.6 Acoustic energy (including infra and ultrasound and vibration, 11.2.2 Medical equipment and systems used in conjunction with oxygen rich environments, 11.4 Medical equipment and systems intended for sue with flammable anesthetic, 11.6.7 Sterilization of medical equipment and systems, 11.6.8 Compatibility with substances used with medical equipment, 12.4.5 Diagnostic or therapeutic radiation, 13.2.13.3 Medical equipment with motors, and 14 Programmable electrical medical systems (PEMS)

Scope History

Action Type	ASCA Status	Effective Start Date	Biocompatibility Test Method	Recognition Number	Designation Number	Exclusions
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 8.5.5 Defibrillation-proof applied parts, 9.5.2 Cathode ray tubes, 9.6 Acoustic energy (including infra and ultrasound and vibration, 9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure, 9.8.3.3 Dynamic forces due to loading from persons, 11.2.2 Medical equipment and systems used in conjunction with oxygen rich environments, 11.4 Medical equipment and systems intended for sue with flammable anesthetic, 11.6.5 Ingress of water or particulate matter into medical equipment and systems, 11.6.7 Sterilization of medical equipment and systems, 11.6.8 Compatibility with substances used with medical equipment, 12.4.5 Diagnostic or therapeutic radiation, 13.2.13.3 Medical equipment with motors, 14 Programmable electrical medical systems (PEMS) NOTE: These exclusions also apply to other collaterals and particulars in the ASCA scope of accreditation)
Transition	Inactive	12/17/2023		5-89	60601-1-6 Edition 3.1 2013-10