The ISO 11607 series, “Packaging for Terminally Sterilized Medical Devices,” has just been updated with the release of amendments for each of the 2 parts. You’ll need the new updates in order to keep your copies of the standards current. Let’s review each amendment separately:
ISO 11607-1, 1st Edition, AMENDMENT 1, Part 1: Requirements for materials, sterile barrier systems and packaging systems, Packaging for terminally sterilized medical devices
This is the lengthier amendment, a total of sixteen pages in all. It includes two pages of pen and ink changes that you’ll need to make to your original copy of the 2006 edition. Next the list of test methods given in Annex B Clause 2 (B.2) is replaced by a brand new Table B.1, Test Methods and Their Status. This new table is seven and a half pages in length! Lastly, extensive changes are made to the bibliography. This new amendment will keep you busy making changes and analyzing the impact.
ISO 11607-2, 1st Edition, AMENDMENT 1, Part 2: Validation requirements for forming, sealing and assembly processes, Packaging for terminally sterilized medical devices
This amendment is going to be a little easier for those of you using the document. It primarily focuses on updating the bibliography. This means you’ll be reviewing your referenced documentation to make sure you’re using the correct editions of a number of standards. And you’ll also want to pay attention to the changes that have been made to the language in Clauses 4.1.3 and 5.3.2.
Of course Document Center customers have already received their notifications about the new amendments. If you’d like this type of timely updating and convenient ordering, you can purchase your copies of the new releases at our webstore, www.document-center.com. Or you may prefer to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Authorized copies of ISO standards are available in paper format, for pdf download, and as part of custom online access subscriptions.
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