MINNEAPOLIS,
August 17, 2004 - Package
Testing expert, DDL Testing Services, has voiced its support
for a revised and harmonized ISO 11607 Packaging for Terminally
Sterilized Medical Devices standard. The International Organization
for Standardization (ISO) is revising ISO 11607 in an attempt
to harmonize with the European Committee for Standardization (CEN)
EN 868-1 standard, meaning that medical
device packaging may be required to comply with only one standard
instead of a myriad of standards for material, package and product
testing requirements.
"Harmonizing
ISO 11607 and EN 869-1 has been the goal of the ISO and CEN ever
since development of these standards was initiated," says
Patrick Nolan, COO of DDL Testing Services. "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."
ISO 11607
currently states that medical device packaging manufacturers "shall
demonstrate that, under the rigors of distribution, storage, handling,
and aging, the integrity of the final package is maintained at
least for the claimed shelf-life of the medical device under storage
conditions specified by the manufacturer, as long as the package
is undamaged or unopened."
The revised
ISO 11607-1; Part 1 and Part 2 standards are designed to harmonize
with EN 868-1, outlining specific requirements for material testing,
validation of medical device packaging and specified shelf-life.
ISO 11607-1 incorporates UN 868 Part 2-10, which only includes
specific requirements for commonly used materials. By harmonizing
with EN 868-1, ISO 11607-1 now includes specific general requirements
to be satisfied by all medical device packaging materials.
"Compliance
to ISO 11607-1 requirements will ensure that medical device packaging
maintains its integrity for the duration of the medical device's
specified shelf-life" says Patrick Nolan. "The best
way for manufacturers to confidently affix valid expiration dates
to their products and avoid package deterioration is to ensure
that their package is submitted to accelerated aging testing."
DDL Testing
Services offers free pre-and-post package, product
and material
testing consultations to help meet and exceed ISO 11607-1
and other industry standards.
About DDL
DDL offers expert package
testing services that provide superior testing and excellent
documentation for package testing, material
testing, product
testing and HazMat
testing. DDL package testing clients find value through its
zero-cost package consulting service, Pack-Advice. DDL maintains
full service testing labs in Minnesota and California. Contact
DDL at www.TestedandProven.com
or call Scott Levy at 952-941-9226 ext.115.
