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John Spitzley

The newly revised ISO 11607: Packaging for Terminally Sterilized Medical Devices not only features reorganized guidelines that make the standards easier to understand, but also accomplishes what the original 1997 version of ISO 11607 failed to do. The new standard eliminates the need for and use of EN 868-1 by incorporating it into the new ISO 11607. The harmonized document covers materials, manufacturing, and package design evaluation standards for terminally sterilized medical device packaging. The draft of the revised ISO 11607 can currently be viewed online and will be published in April. According to John Spitzley of Spartan Design, there will be a formal ballot to withdraw EN 868-1. Spitzley spoke at the MD&M West 2006 conference in Anaheim on Monday.

EN 868-1 is made up of horizontal standards that are general requirements for sterile packaging materials. Vertical standards for specific materials such as sterilization wraps, papers, and Tyvek are included in other parts of EN 868.  The new ISO 11607 incorporates versions of the EN 868-1 standards that have been modified to meet ISO requirements. Spitzley, one of the writers of the original and revised versions of ISO 11607, said that the authors of the 1997 version of ISO 11607 though EN 868-1 would die off after the publication of ISO 11607. However, European companies did not accept ISO 11607. The standard was not widely recognized or used in Europe. As aresult, many companies assumed they needed to comply with both ISO 11607 and EN 868-1 as separate standards.

Harmonizing the two standards also gave Spitzley and his coauthors an opportunity to revise the way in which ISO 11607 is formatted. Spitzley said device manufacturers were having difficulty complying with ISO 11607 and EN 868-1, in part because neither document was easy to read. The documents did not follow the normal packaging development process flow, and EN 868-1 did not cover manufacturing or package design evaluation. At a meeting in Kyoto, Japan, in May 2002, the writers of the new document agreed upon a new format for the harmonized guidelines. The new ISO 11607 is a two-part document in which part one addresses materials (incorporating EN 868-1) and package design, and part two covers package assembly and validation requirements. Part two is a completely new addition to ISO 11607. Nick Fotis of Cardinal Health also spoke at MD&M West about the new combined standard. He outlined key sections of part two, such as test methods and validation requirements including installation qualification, operational qualification, and performance qualification.

This new format also allowed the authors of the standard to develop what, according to Spitzley, they deemed "critical definitions" to make terminology throughout the document more clear and consistent. Definitions were developed for sterile barrier systems (SBS), preformed SBS, protective packaging, and package systems. The harmonized ISO 11607 also includes two new informative annexes, one that provides guidance on medical packaging and another that is an extensive, updated, centralized list of recommended standardized test methods and procedures for packaging materials and preformed SBS.