PRZOOM - /newswire/ -
Minneapolis, MN, United States, 2006/04/28 - Medical device package testing lab, DDL, steps into an educational role to build industry awareness of the impact of imminent ISO 11607 revisions on the medical device industry.
DDL, a leading medical device package testing laboratory, is hosting the second of three free webinars on the upcoming revisions to the ISO 11607 standard – “Packaging for Terminally Sterilized Medical Devices.”
The second ISO 11607 Revisions webinar from DDL, “Understanding Clause 6,” delves into clause 6 of the standard which focuses on a package’s ability to deliver a medical device to the patient without jeopardizing sterility or incurring defect.
“Safe and sterile distribution of a medical device to the end-user is critical,” said Patrick Nolan, COO of DDL. “Changes to ISO 11607 Clause 6 are intended to improve this process, but industry pro’s that do not understand compliance changes may find that their package or product fails when it comes to the testing lab.”
“Understanding Clause 6” presented by Patrick Nolan, COO of DDL Inc, will cover how revisions to ISO 11607 Clause 6 will change compliance requirements for the following:
• Test methods
• Sampling plans
• Materials & performed sterile barrier systems
• Storage & transport regulations
• Closure/seal evaluation
• Accelerated aging protocols
“Clause 6 will be the most changed out of all the ISO 11607 revisions,” said Nolan, “for example, an entire section will be added on the requirements for sterile fluid pathways.”
The “ISO 11607 Revisions – Understanding Clause 6” webinar will air on three different dates:
• May 17, 2006, 12 PM CST (1 EST, 10 PST)
• May 23, 2006, 1 PM CST (2 EST, 11 PST)
• May 25, 2006, 2 PM CST (3 EST, 12 PST)
Register for the “ISO 11607 Revisions – Understanding Clause 6” webinar and listen to the first webinar in this series on the DDL website.
DDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its growing suite of PackServices: PackAdvice, a zero-cost package testing consulting service, and PackReview, a DDL approved certification to demonstrate compliance with ISO 11607 (clause 7). DDL Testing Services maintains full service testing labs in Minnesota and California.