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Update:
Technical Information Report (TIR) for ISO 11607 Revisions
By
Patrick J. Nolan
The
Task Group within the AAMI Sterilization Packaging Working
Group (US Sub-Tag for ISO/TC 198/WG 7, Packaging), developing
a revised TIR No. 22, met at AAMI Headquarters on May 5,
2005.
The
objective of this meeting was to review first drafts of
the new, revised TIR #22 which were based on the outlines
submitted in April by the Contributors. The Committee members,
under the leadership of Mike Scholla of Dupont Medical Packaging,
carried on a spirited discussion about the aspects of developing
a package that complies with the provisions of AAMI/ANSI/ISO
11607, Packaging for terminally sterilized medical devices.
The TIR is developed to help guide the user of 11607 by
interpreting the provisions of the standard and answering
significant questions.
The
new TIR will provide guidance for the new two part ISO 11607
standard in the areas of:
- Device
attributes characteristics or requirements
- Design
control
- Selection
and evaluation of materials
- Package
design
- Package
process feasibility
- Package
design feasibility
- Failure
- Process
validation
- Package
design validation
- Use
of contract manufacturers
The
second draft of the TIR is due to the Chairman on June 1,
2005. This draft will be reviewed by the full ‘Working Group
7’ and discussed in a meeting scheduled for late June.
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