CSA Group tests & certifies your electro-medical equipment to applicable U.S., Canadian and international standards to help you obtain the required approvals for your intended markets. With our network of offices and laboratories in North America, Europe and Asia, our dedicated technical experts can serve you locally wherever you manufacture or sell your electro-medical devices.
Testing & certification
CSA Group is your expert source for testing & certification for a wide variety of electro-medical devices including:
- CT scanning equipment
- Monitoring equipment
- Ultrasound machines
Our testing & certification programs extend to cover not only certification requirements but also applicable EMC Testing to meet the requirements of the U.S. Federal Communications Commission (FCC), the European Union (EU), Industry Canada and other regulatory bodies as well as battery certification.
IEC 60601-1 3rd edition
We have the credentials to provide the approvals to help you sell your electro-medical devices around the world. In fact, we were the first North American organization accredited by ANSI to test to the requirements of the IEC 60601-1 3rd edition.
Under the IECEE CB scheme, CSA Group test reports can be used to secure approvals in many international markets. In addition, our knowledgeable technical representatives will help you understand the ISO 14971 risk management requirements of the widely adopted IEC 60601-1 3rd edition. For countries that have not adopted the 3rd edition, we continue to test to the 2nd edition and can provide you with dual (2nd and 3rd edition) certification.
Let our technical representatives walk you through the IEC 60601-1 3rd edition requirements through our Technical Information Service.
Our extensive experience in developing electrical codes & standards gives us valuable technical knowledge that we apply for you throughout the testing & certification process. Our work in developing standards for medical devices and systems help build safety & performance into life-saving support systems.
Our expertise earns us recognition from leading manufacturers and end-users around the world who look for the CSA mark on products to indicate that applicable standards have been met.