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As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.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: SIGMA SCIENTIFIC SERVICES LLC [TL-114]

Accreditation Status: Accreditation Granted - Date: 08/17/2022

Accreditation Body Organization Name: A2LA

Test Lab Primary Contact: Jorge Millan, jmillan@sigmabiomedical.com, 490 Sawgrass Corporate Parkway Suite 130 Sunrise FL US 33325

Status	Status Date	Category	Biocompatibility Test Method	Recognition Number	Standards Development Organization	Standard Designation Number and Date	Title	Exclusions
Accreditation Granted	08/17/2022	Basic safety and essential performance		12-205	IEC	60601-2-5: Edition 3.0 2009-07	Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment	The following exclusions apply to ANSI/AAMI ES60601-1: Subclauses 10.1-10.7. Note: Exclusions listed for ANSI AAMI ES60601-1 also apply to other collaterals and particulars in the 60601/80601 family of standards except where otherwise stated.
Accreditation Granted	08/17/2022	Basic safety and essential performance		12-281	IEC	60601-2-62 Edition 1.0 2013-07	Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment	The following exclusions apply to ANSI/AAMI ES60601-1: Subclauses 10.1-10.7. Note: Exclusions listed for ANSI AAMI ES60601-1 also apply to other collaterals and particulars in the 60601/80601 family of standards except where otherwise stated.
Accreditation Granted	08/17/2022	Basic safety and essential performance		12-293	IEC	60601-2-37 Edition 2.1 2015	Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment	The following exclusions apply to ANSI/AAMI ES60601-1: Subclauses 10.1-10.7. Note: Exclusions listed for ANSI AAMI ES60601-1 also apply to other collaterals and particulars in the 60601/80601 family of standards except where otherwise stated.
Accreditation Granted	08/17/2022	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	The following exclusions apply to ANSI/AAMI ES60601-1: Subclauses 10.1-10.7. Note: Exclusions listed for ANSI AAMI ES60601-1 also apply to other collaterals and particulars in the 60601/80601 family of standards except where otherwise stated.
Accreditation Granted	09/09/2024	Basic safety and essential performance		19-46	ANSI, AAMI	ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]	The following exclusions apply to the ANSI/AAMI ES60601: Clauses 10.1-10.7. Note: Exclusions listed for ANSI AAMI ES60601-1 also apply to other collaterals and particulars in the 60601/80601 family of standards except where otherwise stated.
Accreditation Granted	09/09/2024	Basic safety and essential performance		19-49	IEC	60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
Accreditation Granted	09/09/2024	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
Accreditation Granted	09/09/2024	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
Accreditation Granted	09/09/2024	Basic safety and essential performance		6-461	IEC	60601-2-19 Edition 3.0 2020-09	Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Accreditation Granted	09/09/2024	Basic safety and essential performance		6-462	IEC	60601-2-20 Edition 3.0 2020-09	Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
Accreditation Granted	09/09/2024	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

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	The following exclusions apply to ANSI/AAMI ES60601-1: Subclauses 10.1-10.7. Note: Exclusions listed for ANSI AAMI ES60601-1 also apply to other collaterals and particulars in the 60601/80601 family of standards except where otherwise stated.
Transition	Inactive	12/17/2023		19-16	HA60601-1-11:2015	The following exclusions apply to ANSI/AAMI ES60601-1: Subclauses 10.1-10.7. Note: Exclusions listed for ANSI AAMI ES60601-1 also apply to other collaterals and particulars in the 60601/80601 family of standards except where otherwise stated.
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)	The following exclusions apply to ANSI/AAMI ES60601-1: Subclauses 10.1-10.7. Note: Exclusions listed for ANSI AAMI ES60601-1 also apply to other collaterals and particulars in the 60601/80601 family of standards except where otherwise stated.