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As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.

Learn more...

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

Test Lab: TUV SUD America, Inc. - New Brighton [TL-15]

Accreditation Status: Accreditation Granted - Date: 04/12/2021

Accreditation Body Organization Name: A2LA

Test Lab Primary Contact: William Elliott, William.Elliott@tuvsud.com, 141 14th St NW New Brighton MN US 55112

Status	Status Date	Category	Biocompatibility Test Method	Recognition Number	Standards Development Organization	Standard Designation Number and Date	Title	Exclusions
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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
Accreditation Granted	04/12/2021	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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
Accreditation Granted	04/12/2021	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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
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	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.

Scope History

Action Type	ASCA Status	Effective Start Date	Biocompatibility Test Method	Recognition Number	Designation Number	Exclusions
Transition	Inactive	12/17/2023		19-14	60601-1-11 Edition 2.0 2015-01	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
Transition	Inactive	12/17/2023		19-15	60601-1-12 Edition 1.0 2014-06	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
Transition	Inactive	12/17/2023		19-16	HA60601-1-11:2015	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
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)
Transition	Inactive	12/17/2023		19-9	60601-1-10 Edition 1.1 2013-11	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
Transition	Inactive	12/17/2023		5-76	60601-1-8 Edition 2.1 2012-11	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
Transition	Inactive	12/17/2023		5-89	60601-1-6 Edition 3.1 2013-10	Excluding: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.