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As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.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: WuXi Apptec Suzhou [TL-83]

Accreditation Status: Accreditation Granted - Date: 05/10/2023

Accreditation Body Organization Name: A2LA

Test Lab Primary Contact: Jiyi Duan, ASCA@wuxiapptec.com, No. 818 Songjia Road, Guoxiang Street Wuzhong District Suzhou, Jiangsu CN 215124

Status	Status Date	Category	Biocompatibility Test Method	Recognition Number	Standards Development Organization	Standard Designation Number and Date	Title	Exclusions
Accreditation Granted	05/10/2023	Biocompatibility	MEM Elution Cytotoxicity	2-245	ISO	10993-5 Third edition 2009-06-01	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Accreditation Granted	11/20/2024	Biocompatibility	Complement Activation using a U.S. marketed ELISA kit	2-248	ISO	10993-4 Third edition 2017-04	Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
Accreditation Granted	06/14/2023	Biocompatibility	Direct and Indirect Hemolysis	2-248 2-250	ISO ASTM	10993-4 Third edition 2017-04 F756-17	Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood Standard Practice for Assessment of Hemolytic Properties of Materials
Accreditation Granted	05/10/2023	Biocompatibility	Sample preparation for all test types	2-289	ISO	10993-12 Fifth edition 2021-01	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

Scope History

Action Type

ASCA Status

Effective Start Date

Biocompatibility Test Method

Recognition Number

Designation Number

Exclusions