SGS Fimko has expanded its accredited*) scope with a new technical specification.
IEC TS 60601-4-2:2024 (and the older version IEC TR 60601-4-2:2016)
The specification defines immunity requirements for the functionality of medical devices. The specification applies to functions that are not related to the basic safety or essential function of the medical device, in contrast to the standard IEC 60601-1-2:2014. Thanks to the expansion, SGS Fimko is able to help medical device manufacturers, especially in entering the US market, as the local authority, the FDA, recommends compliance with the requirements of the specification.
In addition, SGS Fimko has expanded its accredited scope of competence with the following standard
IEC 61000-4-18:2019 (Immunity testing for damped oscillatory waves)
This basic standard defines an immunity test, the requirements of which are required for applications related to energy production and transmission, such as power plants. For manufacturers of equipment installed in power plant environments, SGS Fimko is now able to offer qualified testing in Finland.
You can view our entire scope of competence on the FINAS accreditation service website.
For more information, please contact:
Sami Holopainen
Project Manager
t. +358 41 7325246
*) SGS Fimko Oy's testing laboratory is a FINAS accredited testing laboratory T004, accreditation requirement EN-ISO/IEC 17025.
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
