ISO 11607-1 Consolidates Medical Device Package Testing Standards - DDL Testing Services Supports New Compliance Requirements for Packaging Materials

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