DDL Testing Services Supports New Compliance Requirements for Packaging Materials
DDL Testing Services voices support for a revised ISO 11607 Packaging for Terminally Sterilized Medical Devices standard, in which 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.
(PRWEB) August 17, 2004 -- http://www.testedandproven.com – 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
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Source : http://www.prweb.com/releases/2004/8/prweb150244.htm
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