Withdrawn ASCA Testing Laboratories

This page lists testing laboratories who have either 1) voluntarily withdrawn their ASCA Accreditation or 2) have had their ASCA Accreditation withdrawn through an FDA-initiated process. See below for more details.

Notes:

Labs listed below with a status of "FDA Initiated Withdrawal" have had their ASCA Accreditation withdrawn as a result of failing to meet the requirements of the ASCA Program as detailed in Section 514(d) of the FD&C Act and the relevant ASCA guidance documents. For some labs listed with a status of "FDA Initiated Withdrawal," the FDA has identified data integrity concerns with testing conducted by the testing laboratory and submitted to the agency in premarket submissions.

Labs listed below with a status of "Voluntarily Withdrawn" have requested that their ASCA Accreditation be withdrawn voluntarily. This is often due to business decisions (e.g. closing of or moving the laboratory location, limited laboratory services, etc.).

See currently ASCA-accredited Test Labs here ASCA-Accredited Testing Laboratories

Learn more...

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

Test Lab: TUV SUD America, Inc. - Peabody [TL-14]

Accreditation Status: Voluntarily Withdrawn - Start Date: 04/12/2021 - End Date: 01/09/2024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 (select icon to view/hide 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.