IEC 62304 Amendment 1 published
The new version of IEC 62304, also known as IEC 62304:2015 or amendment 1 of IEC 62304 was published by the IEC at the end of June 2015.
There were no major changes compared to the drafts that were circulated earlier this year.
The two major new requirements, compared to IEC 62304:2006 are:
- Requirements about legacy software,
- Changes in the definition of the security classes, based on risk assessment.
IEC 62304:2015 is available on IEC website at the astounding / amazing / appealing / astonishing (delete as appropriate) price of 650 swiss francs (approx. US$700) for the consolidated version.
Now we need to wait for this version to be harmonized by EU and recognized by the USA.