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As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.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 SÜD America, Inc. - Peabody [TL-14]

Accreditation Status: Voluntarily Withdrawn - Date: 01/09/2024

Accreditation Body Organization Name: A2LA

Test Lab Primary Contact: 10 Technology Dr Unit B Peabody

Status

Status Date

Category

Biocompatibility Test Method

Recognition Number

Standards Development Organization

Standard Designation Number and Date

Title

Exclusions

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 Cathode Ray Tube, Effect of UV Radiation on Materials, EMC Testing, Pressure Vessels, Human Exposure to UV Radiation, IR/UV Radiation Testing, Acoustic Testing, ESD Testing, Laser Power, Bio Compatibility Testing, Microwave Power, Laser Photo-detection, X-radiation, Oxygen Bomb Test, Cord Reel Test, and Vibration Test.
Transition	Inactive	12/17/2023		19-15	60601-1-12 Edition 1.0 2014-06	Excluding Cathode Ray Tube, Effect of UV Radiation on Materials, EMC Testing, Pressure Vessels, Human Exposure to UV Radiation, IR/UV Radiation Testing, Acoustic Testing, ESD Testing, Laser Power, Bio Compatibility Testing, Microwave Power, Laser Photo-detection, X-radiation, Oxygen Bomb Test, Cord Reel Test, and Vibration Test.
Transition	Inactive	12/17/2023		19-16	HA60601-1-11:2015	Excluding Cathode Ray Tube, Effect of UV Radiation on Materials, EMC Testing, Pressure Vessels, Human Exposure to UV Radiation, IR/UV Radiation Testing, Acoustic Testing, ESD Testing, Laser Power, Bio Compatibility Testing, Microwave Power, Laser Photo-detection, X-radiation, Oxygen Bomb Test, Cord Reel Test, and Vibration 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 Cathode Ray Tube, Effect of UV Radiation on Materials, EMC Testing, Pressure Vessels, Human Exposure to UV Radiation, IR/UV Radiation Testing, Acoustic Testing, ESD Testing, Laser Power, Bio Compatibility Testing, Microwave Power, Laser Photo-detection, X-radiation, Oxygen Bomb Test, Cord Reel Test, and Vibration Test.
Transition	Inactive	12/17/2023		5-76	60601-1-8 Edition 2.1 2012-11	Excluding Cathode Ray Tube, Effect of UV Radiation on Materials, EMC Testing, Pressure Vessels, Human Exposure to UV Radiation, IR/UV Radiation Testing, Acoustic Testing, ESD Testing, Laser Power, Bio Compatibility Testing, Microwave Power, Laser Photo-detection, X-radiation, Oxygen Bomb Test, Cord Reel Test, and Vibration Test.
Transition	Inactive	12/17/2023		5-89	60601-1-6 Edition 3.1 2013-10	Excluding Cathode Ray Tube, Effect of UV Radiation on Materials, EMC Testing, Pressure Vessels, Human Exposure to UV Radiation, IR/UV Radiation Testing, Acoustic Testing, ESD Testing, Laser Power, Bio Compatibility Testing, Microwave Power, Laser Photo-detection, X-radiation, Oxygen Bomb Test, Cord Reel Test, and Vibration Test.
Transition	Inactive	12/17/2023		6-385	60601-2-19 Edition 2.1 2016-04	Excluding Cathode Ray Tube, Effect of UV Radiation on Materials, EMC Testing, Pressure Vessels, Human Exposure to UV Radiation, IR/UV Radiation Testing, Acoustic Testing, ESD Testing, Laser Power, Bio Compatibility Testing, Microwave Power, Laser Photo-detection, X-radiation, Oxygen Bomb Test, Cord Reel Test, and Vibration Test.
Transition	Inactive	12/17/2023		6-386	60601-2-20 Edition 2.1 2016-04	Excluding Cathode Ray Tube, Effect of UV Radiation on Materials, EMC Testing, Pressure Vessels, Human Exposure to UV Radiation, IR/UV Radiation Testing, Acoustic Testing, ESD Testing, Laser Power, Bio Compatibility Testing, Microwave Power, Laser Photo-detection, X-radiation, Oxygen Bomb Test, Cord Reel Test, and Vibration Test.
Transition	Inactive	12/17/2023		6-388	60601-2-21 Edition 2.1 2016-04	Excluding Cathode Ray Tube, Effect of UV Radiation on Materials, EMC Testing, Pressure Vessels, Human Exposure to UV Radiation, IR/UV Radiation Testing, Acoustic Testing, ESD Testing, Laser Power, Bio Compatibility Testing, Microwave Power, Laser Photo-detection, X-radiation, Oxygen Bomb Test, Cord Reel Test, and Vibration Test.