IEC 60601- 1

Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of an electrical medical equipment in many countries.[1] Many companies view compliance with IEC 60601-1 as a requirement for most markets.

http://en.wikipedia.org/wiki/IEC_60601