To forum members, the following is an article which discusses retrospective application of harmonized standards, triggered by the upcoming end of transition for EN 60601-1:2006 (IEC 60601-1:2005). It's a bit complicated since it goes into MDD and EU law, but the conclusion has a big impact:
http://www.medteq.info/med/HarmStdRetro
I'm interested in any comments or feedback.
http://www.medteq.info/med/HarmStdRetro
I'm interested in any comments or feedback.