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CFDA: Electromagnetic Compatibility Standards for Medical Devices

6. November 2013

The CFDA has developed a standard for electromagnetic compatibility (EMC) of medical devices to insure safety. This industry standard YY0505-2012 corresponds to the International standard IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests) and the Chinese Standard GB 9706.1-2007 (Medical electrical equipment – Part 1: General requirements for safety). The industry standard YY0505 2012 was announced in December 2012 and will be implemented from the 1st of January 2014 as a mandatory industry standard for electrical medical devices in the Peoples Republic of China.

You can find more information about CFDA registration here.




















MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

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