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Media Coverage

What ISO 11607 revisions mean to you (Part 2)

Karen Sams Karen

hcp_logo.gifHealthcare Packaging

Article Summary

Medical device manufacturers must take care up front with contractors and vendors to determine roles and responsibilities in the entire package development and validation process.

Most of the changes to the Standard will have little effect on how you design your packaging and sterile barrier systems for your devices. However, there are some nuances that will require additional testing and some subtleties for performing a final package system validation as described in Clause 6.

Common Mistakes in Validating Packaging Systems

Karen Sams Karen

MD&DI1.jpgMedical Device & Diagnostic Industry

Article Summary

A medical device’s package plays a key role in safely delivering treatment to patients. It must ensure the integrity of the device from the point of manufacture to the point of final use. In addition, packaging often has a direct function in the application of the treatment; for example, it may act as a fixture or a dispenser. Therefore, mechanical damage to a package cannot be tolerated. Device components and packaging systems must combine to create a product that performs efficiently, safely, and effectively in the hands of the user.

Market Intelligence - New Website for DDL

Karen Sams Karen

Twin Cities Business Journal
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ISO 11607 Revisions Webinar from DDL Describes Changing Requirements for Distribution of Medical Devices

Karen Sams Karen

IDS Packaging Ideas Newsletter

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Article Summary

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.”

Industry Watch - ASTM Committee D-10 Chairman Elected

Karen Sams Karen

Medical Design Technology   medical design.jpg
Article Summary

Package testing expert, Patrick Nolan, COO of DDL—a leading package, product, and material testing laboratory—has been elected chairman of the ASTM Committee D-10 on Packaging.


10 Tips for Successfully Working with a Packaging Testing Lab

Karen Sams Karen

IDS Packaging Ideas Newsletter   IDS.jpg

Article  Summary

Many packaging manufacturers struggle to understand what they need to do to test and certify their packages. Here are 10 tips to help you work efficiently and effectively with a third party package testing lab and to satisfy your package testing expectations.

Package Testing Lab COO, Patrick Nolan, Becomes Chairman of ASTM Committee D-10 on Packaging

Karen Sams Karen

IDS Packaging Ideas Newsletter IDS.jpg

Article Summary

Minneapolis, MN, Package testing expert, Patrick Nolan, COO of DDL, a leading package, product and material testing laboratory, has been elected Chairman of the ASTM Committee D-10 on Packaging.

The American Society for Testing & Materials (ASTM) created the D-10 on Packaging Committee in 1914 to discuss the revision and development of regulated packaging standards.


ISO 11607 Revisions - What They Mean For Packagers

Karen Sams Karen

The International Standards Organization (ISO) 11607 standard is the foremost guidance document for validating packaging for terminally sterilized medical devices.  Packaging must comply with ISO 11607 to ensure that the enclosed medical device is kept sterile throughout manufacturing, shipping, and storage environments.

Industry News - Updated ISO Packaging Standard Nears Publication

Karen Sams Karen

Medical Device & Diagnostic Industry MD&DI1.jpg
Article Summary

Revisions to ISO 11607, “Packaging for Terminally Sterilized Medical Devices,” accomplishes what the original 1997 version failed to do. The new standard eliminates the need for a European packaging standard, EN 868-1 by incorporating it. The harmonized document covers materials, manufacturing, and package design evaluation standards for terminally sterilized medical device packaging.

Free Webinar Series: ISO 11607 Revisions

Karen Sams Karen

Medical Design Technology MDT.jpg
 Article Summary

DDL, a leading package, product and material testing laboratory, is hosting a series of free webinars on how upcoming revisions to the ISO 11607 standard will impact packaging professionals.