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U.S. Department of Health and Human Services

Withdrawn ASCA Testing Laboratories
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This page lists testing laboratories who have either 1) voluntarily withdrawn their ASCA Accreditation or 2) have had their ASCA Accreditation withdrawn through an FDA-initiated process.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  • Labs listed below with a status of "FDA Initiated Withdrawal" have had their ASCA Accreditation withdrawn as a result of failing to meet the requirements of the ASCA Program as detailed in Section 514(d) of the FD&C Act and the relevant ASCA guidance documents.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  • Labs listed below with a status of "Voluntarily Withdrawn" have requested that their ASCA Accreditation be withdrawn voluntarily.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

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    Test Lab: Philips Medical Systems - Andover Standards and Reliability Center [TL-59]
    Accreditation Status: Voluntarily Withdrawn - Start Date: 04/12/2021 - End Date: 04/15/2026
    Accreditation Body Organization Name: ANSI National Accreditation Board (ANAB)
    Test Lab Primary Contact: Daniel Doherty, daniel.doherty@philips.com, 3000 Minuteman Road Suite 200 Andover MA US 01810
     
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    Exclusions
    Transition Inactive 12/17/2023 19-14
    		 60601-1-11 Edition 2.0 2015-01
    Excludes assessments above local atmospheric pressure for Sub-clauses 4.2.2, 4.2.3
    Transition Inactive 12/17/2023 19-15
    		 60601-1-12 Edition 1.0 2014-06
    Sub-clause 4.1: Excludes additional requirements for supply mains (30 s voltage dips on 12V and 24V supply mains.) | Sub-clause 4.2.2.1: Excludes assessments above Select to expand and show more text
    Transition Inactive 12/17/2023 19-16
    		 HA60601-1-11:2015
    Excludes assessments above local atmospheric pressure for Sub-clauses 4.2.2, 4.2.3
    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)
    8.8.4.2 Natural rubber latex aging 9.6.2.1 Audible acoustic energy for impulses and impact 9.6.3 Hand transmitted vibration 9.7.5 Pressure vessels 9.7.6 Pressure control 9.7.7 Select to expand and show more text
    Transition Inactive 12/17/2023 19-8
    		 60601-1-2 Edition 4.0 2014-02
    Excluding tests according to CISPR 14-1 and ISO 7637-2
    Transition Inactive 12/17/2023 5-76
    		 60601-1-8 Edition 2.1 2012-11
    Transition Inactive 12/17/2023 5-89
    		 60601-1-6 Edition 3.1 2013-10
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