Medical equipment is usually in electromagnetic environment, and the consequences of EMI on medical equipment or system are often serious.
According to a study released by the FDA , there is about 73.6% were caused by suspected EMI interference in 550 adverse events from January 1994 to March 2005. Among these suspected EMI disturbances ,43.5% of deaths and injuries occurred. EMI medical malpractice has attracted the attention of governments.
European medical device directives have three EU directives based on different types of medical devices. AIMD 90/335/EEC、MDD 93/42/EEC and IVD 98/79/EEC., China implemented the YY0505-2012(idt IEC60601-1-2:) instruction on January 1,2014.