New safety standard for medical equipment

The new international standard for electrical medical equipment is IEC 60601-1 3rd ed. The European version is EN 60601-1:2006.

In Europe, the expiry date of the previous version is 1 June 2012, and by then, products marketed in Europe must be in compliance with the new version, (unless further delayed due to not yet published relevant Part 2 standard for the particular type of equipment).
The new standard contains significant changes affecting both the product and the manufacturing company. Therefore, it may take time to implement.

Important new features include requirements for risk management of the product according to ISO 14971, and integration of software validation and medical systems.

There are also major changes regarding safety requirements for both the patient and the operators, as well as concerning mechanical hazards and radiation hazards.

For more information, please contact grant [dot] schmidbauer [at] nemko [dot] com