DDL Inc., a medical device package testing lab, will present a webinar to explain upcoming revisions to ISO 11607.The standard applies to organizations that package terminally sterilized medical devices. “Understanding Clause 6” will focus on a package’s ability to deliver a medical device to a patient without jeopardizing its sterility or incurring defects. Patrick Nolan, DDL’s chief operating officer, will explain compliance requirement changes to testing methods, sampling plans, materials and performed sterile barrier systems, storage and transport regulations, closure and seal evaluations, and accelerated-aging protocols.

“Clause 6 will be the most changed out of all the ISO 11607 revisions,” says Nolan. “For example, an entire section will be added on the requirements for sterile fluid pathways.”

The webinar will be held on May 23 at 1 p.m. CST and on May 25 at 2 p.m. CST. For more information, visit www.testedandproven.com/webinars.html.

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