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Keeping up to date with medical-safety standards PDF The 3rd edition of the 60601 medical-safety standard was first published by the IEC in 2005 (IEC60601-1:2005), was adopted by the EU (European Union) in 2006, and published as EN60601-1:2006. The AAMI (American Association for Medical Instrumentation) published the USA version, also in 2006, which appears as ANSI/AAMI ES60601-1:2006.
By 22 July 2014 all medical devices must be compliant to the RoHS II legislative Directive (2011/65/EU). The key question is, are you ready? It may feel like the deadline crept up rather fast for some, but we’ve known since July 2011 when RoHS II was published. There has been plenty of time, but if you’ve only just started (or worse, done nothing) , it may not be as bad as you first thought.
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