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As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.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: VPI Laboratories, Inc [TL-99]

Accreditation Status: Accreditation Granted - Date: 02/09/2202

Accreditation Body Organization Name: National Voluntary Laboratory Accreditation Program (NVLAP)

Test Lab Primary Contact: Jason Stewart, jasons@vpitech.com, 313 W 12800 S Suite 311 Draper UT US 84020

Status	Status Date	Category	Biocompatibility Test Method	Recognition Number	Standards Development Organization	Standard Designation Number and Date	Title	Exclusions
Accreditation Granted	02/09/2022	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 RISK for: Flammability test, Ionizing radiation, UV radiation, Microwave radiation, Ultrasonic pressure, IP testing, Laser sources, Interlock Reliability
Accreditation Granted	11/18/2022	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 Figure 3, "nursing homes" as an example of the HOME HEALTHCARE ENVIRONMENT, Subclause 8.9, Table 8 on Page 39: The citation of Note b) under "Conducted disturbances induced by RF fields" (4th Row). Accreditation excludes clause 8.9, table 6 and clause 7.2, table 2.
Accreditation Granted	11/18/2022	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 "Note 2 to entry" in Sub-clause 3.1 (Home Healthcare Environment)

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
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 Defibrillation protection, Pressure vessels, X-radiation, Microwave radiation, Lasers, Sterilization, Lithium batteries per IEC 60086-4 and IEC 62133, Ingress of water or particulate matter, IP testing, Protection against hazards of ignition of flammable anesthetic mixtures
Transition	Inactive	12/17/2023		19-8	60601-1-2 Edition 4.0 2014-02	Excluding Figure 3, "nursing homes" as an example of the HOME HEALTHCARE ENVIRONMENT, Subclause 8.9, Table 8 on Page 39: The citation of Note b) under "Conducted disturbances induced by RF fields" (4th Row). Accreditation excludes clause 8.9, table 6 and clause 7.2, table 2