FDA require transition to IEC 60601-1 Ed.3.0 by end of 2013

摘要

The US federal Food and Drug Administration (FDA) has extended the date by which makers and importers of electrical medical equipment must start using IEC 60601-1 Ed.3.0 (2005-12). This standard will typically be used when a declaration of conformity is made as part of a premarket submission to the FDA.