Hello all
ISO TC 210 JWG 2 met this week to further discuss the revision of IEC 62304 (and the creation of IEC TR 80002-2).
We've finally managaed to come to mature the working draft enough to circulate a first committee draft.
The main idea behind the revision is to clarify some confusing parts of the standard, for example, to clarify software safety classification issue.
Another interesting development was the addition of an annex to deal with legacy software (software created before IEC 62304 was created and still used today). It follows the same idea of the legacy annex to the usability standard (62304) to permit that manufacturrs follow an alternative process when applying IEC 62304 to legacy software (otherwise all software would need to be redesigned to meet the standard ).
For those which can have access thru the National Committes, expect a CD in the following months.
ISO TC 210 JWG 2 met this week to further discuss the revision of IEC 62304 (and the creation of IEC TR 80002-2).
We've finally managaed to come to mature the working draft enough to circulate a first committee draft.
The main idea behind the revision is to clarify some confusing parts of the standard, for example, to clarify software safety classification issue.
Another interesting development was the addition of an annex to deal with legacy software (software created before IEC 62304 was created and still used today). It follows the same idea of the legacy annex to the usability standard (62304) to permit that manufacturrs follow an alternative process when applying IEC 62304 to legacy software (otherwise all software would need to be redesigned to meet the standard ).
For those which can have access thru the National Committes, expect a CD in the following months.