ISO 11607 Update

In November 2008, ISO Technical Committee 198 of the Packaging Working Group 7 (ISO/TC 198/WG 7) met to discuss the development of additional guidance for ISO 11607 as well as pending revisions to European Directives on Medical Devices.

ISO/TC 198/WG 7 is undertaking the development of new ISO 11607 guidance for hospital supply staff and other sterile medical device support. Tim Galekop, director of global business development, Ahlstrom Corp., shared with the committee the needs of end-users in healthcare facilities. “Guidance on ISO 11607 will be of fundamental importance,” he explained.

The committee agreed that the new guidance should result in a “purely educational document to ISO 11607-1 and ISO 11607-2 addressing both industry and end-users,” explains Jackie Daly Johnson, president of Beacon Converters and a committee member representing the U.S. delegation. She says the project won’t be designated Part 3 of the series ISO 11607, but rather be published outside the series in order to have a clear formal separation between “requirements” and “guidance.”

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The U.S. delegation offered AAMI’s Technical Information Report (TIR) 22 and the amendment to that TIR as first working drafts. In particular, Annex J of AAMI TIR 22, including the guidance for healthcare facilities, was discussed. It was agreed that this annex needs to be raised from the annex level to its own section of the new guidance document. The members of ISO/TC 198/WG 7 named U.S. delegate Johnson as convenor of a task force charged with rewriting the healthcare facility use section, taking into consideration current hospital and central supply organization guidance from around the world. The Sterilization Packaging Working Group of the AAMI Sterilization Standards Committee will coordinate the U.S. comments on this evolving document.

As part of the upcoming revision of the European Directives on Medical Devices, CEN/TC 102 is preparing an amendment to EN ISO 11607-1 in order to address the applicable modified Essential Requirements of the Directive 93/42/EC. This proposed amendment will only modify the Table ZA.1 of EN ISO 11607-1, which is the very specific European element, but not the body of the standard. No changes to ISO 11607-2 are necessary at this time.

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