Your products must meet many legal requirements in North America, and ensuring that your product carries a recognized safety certification mark is one of them.
CSA International is one of two leading certification institutions in North America that can provide you with the safety certification marks. We have been testing and certifying products for domestic, commercial and industrial use for more than 90 years – always with a focus on safety.
You can find an overview of our services for electro-medical equipment here.
Get information on our European CB test laboratory located in Switzerland, in Gebenstorf near Zürich. The CBTL provides manufacturers of electro-medical and lab equipment with a streamlined and efficient process for obtaining a CSAI CB certificate for exporting their products globally.
CSA International (CSAI) has established its first Certified Body Test Lab (CBTL) in Europe with INTRATest and in April 2011 INTRATest GmbH was acquired by CSA Group. The Swiss based lab is located in Gebenstorf near Zurich. The European CBTL provides manufacturers of electro-medical and lab equipment with a streamlined and efficient process for obtaining a CSAI CB certificate for exporting their products globally.
CSAI acts as the responsible National Certification Body (NCB) – and issues the CB certificates based on the INTRATest CB test reports.
CSAI and INTRATest can provide the adjacent German speaking countries with local service in the local preferred language.
CSAI and INTRATest offer the following joint services:
- Access to the North American Market with the CSA mark for the USA and Canada (NRTL)
- Global market access to Europe, South America, Asia, Australia, Russia, etc.
- Test reports for compliance with regulations used for conformity assessment
- Electromagnetic compatibility (EMC)
- Technical Information Service to review the standards requirements
- Support for technical documentation for medical devices based on the Medical Device Directive (MDD)
- Evaluation services during the product development process
- Risk management process assessment according to ISO 14971
- Standards consultation services according to ISO 13485 for quality management systems
INTRATest
Established in 1995 in Gebenstorf near Zürich, Switzerland. INTRATest areas of expertise include in-depth knowledge of the applicable standards, approval regulations and their interpretation and application in product design. INTRATest has been accredited by the Swiss Accreditation Service (SAS) according to ISO/IEC 17025 for Electromagnetic Compatibility (EMC) and Product Safety and all relevant standards since 2001. INTRATest was officially recognized by CSA International as an agent in 2008 and is a CSA company since April 2011. INTRATest is a CBTL accredited by IECEE since 2010.
CSA International Europe
Utrechtseweg 310
6812 AR Arnhem, Holland
Phone +31 26 356 3915
Fax +31 26 445 3033
INTRATest GmbH
Reusswehrstr. 1
5412 Gebenstorf, Switzerland
Phone +41 56 201 95 00
Fax +41 56 201 95 05