The IEC 60601-1 standard is a globally recognized standard for electro-medical equipment safety, and a parent standard over 60 particular device standards. The third edition (3rd), issued in 2005, has a compliance date of June 2012 for the European market (EN 60601-1:2006), and July 2013 for the US market under FDA and OSHA regulations (ANSI/AAMI ES60601-1:2005), and is radically different from the preceding, second edition (2nd) standard.
One addition is a clause to conform to the ISO14971 regulations for risk management. This ISO regulation establishes requirements for the manufacturer to employ risk management in determining the safety of a medical device during its product life cycle. IEC 60601-1, 3rd Edition has several other updated regulations concerning: general requirements for medical devices; standards for identification, marking and providing accompanying documents; hazards (electrical, mechanical, radiation, temperature and fire, accuracy, etc.); and hazardous situations and fault conditions. The purpose of these rules is to ensure that equipment manufacturers have safety, performance, and risk management control measures in place.
IEC 60601-1 3rd Edition Mandatory Adoption Dates
- Europe: June 1, 2012
- Canada: June 1, 2012
- USA: July 1, 2013