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Strategies for complying with the globally harmonised medical packaging standard.

Article Excerpt
Terminally sterilised medical devices placed on the European market after May 2007 must meet the recently introduced packaging requirements set out in ISO EN 11607, Parts 1 and 2. Some areas of the standard such as test method validation and stability studies are raising queries when companies come to apply the regulation. Guidance on how to address these areas is provided here.

Towards worldwide adoption

The new globally harmonised standard for packaging terminally sterilised medical devices was ratified as an ISO and European standard in April 2006. The standard has two parts:

* ISO EN 11607-1:2006, "Packaging for Terminally Sterilised Medical Devices, Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems," sets out the obligations for materials, sterile barrier systems and package design.

* ISO EN 11607-2:2006 "Packaging for Terminally Sterilised Medical Devices, Part 2: Validation Requirements for Forming, Sealing and Assembly Processes," addresses requirements for validation of the packaging process.

This standard replaces the previous European standard EN 868-1. From May 2007, new terminally sterilised medical devices placed on the European Union (EU) market place must comply with ISO EN 11607 Parts 1 and 2. These two standards have also been officially "recognised" by the United States (US) Food and Drug Administration (FDA) via the standards recognition process and published in the Federal Register. Several countries outside the EU, including China and Japan, are also considering adopting the standard as official guidance or regulatory requirements.

Help with compliance

To comply with the new regulation, a medical device manufacturer must meet the requirements of each "shall" statement in the standard. There are one hundred and nineteen unique "shall" statements in ISO EN 11607 Parts 1 and 2. The question is how can this be achieved? Several articles, seminars and webinars designed to describe the standard and strategies for compliance have been presented over the past eighteen months. The Association for the Advancement of Medical Instrumentation (AAMI) has revised Technical Information Report (TIR) 22: "Guidance for ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices Part 1 and Part 2: 2006." This guidance was specifically written...

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