The ISO 11607 Revisions.
Webinars on the revisions to ISO 11607, Packaging for Terminally Sterilised Medical Devices, have prompted many questions from manufacturers and package engineers concerned with validating their packaging under the new requirements. A selection of those questions are reviewed here.
Nolan
P J
PJ
DDL Inc., Eden Prairie, Minnesota 55344, USA. pat.nolan@testedandproven.com
D019544:Equipment Failure Analysis / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D038622:Internationality; D019064:Product Packaging / Q000592:standards*; D013242:Sterilization / Q000592:standards*