Re: IEC60601-1-6:2006--Is it a standards used together with60601-1
Yes. In fact, you "can" implement any standard you want anytime you want but you "must" implement the harmonized or recognized ones (or deal with the related risk in other ways) when they become recognized or harmonized.
In fact, usability is a requirement of both FDA and MDD, so you HAVE to deal with the risks related to usability. Complying with IEC 60601-1-6 is the easiest means to do that.
I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
Last edited by Marcelo Antunes; 17th September 2008 at 10:03 PM.
Reason: Why so serious?