ISO 11607-1 CONSOLIDATES MEDICAL DEVICE PACKAGE TESTING STANDARDS
August 17th, 2004DDL Testing Services Supports New Compliance Requirements for Packaging Materials
MINNEAPOLIS, 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.”










