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The
ISO 11607 standard is being revised to harmonize the EN
868-1 standard which has been a goal of ISO and CEN since
the development of these standards was initiated. Many factors
prevented the groups from working jointly on the standard
for medical device packaging and each developed their own
versions. However, resolutions were passed in each group
affirming that efforts should be made to harmonize the ISO
and CEN documents in future revisions.
The
ISO 11607-1 is designed to harmonize with EN 868-1 and specifies
general requirements to all packaging materials, whereas
UN 868 Part 2-10 specify particular requirements for a range
of commonly used materials. Both parts of ISO 11607 were
written to meet the 'Essential Requirements' of the European
Medical Device Directives.
Most
comments from ballots received involved editorial issues
to remove redundancies and improve clarity. Due to the phase
that these standards are in development, there are few opportunities
at this point to effect significant change in the content.
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