The integrated EN ISO 11607-2, “Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes ,” has just been released. The document is the European adoption of ISO 11607-2:2006/Amd 1:2014. It replaces the previous 2006 Edition and is available in paper format, for pdf download, and for multi-user access from Document Center Inc.
If you’ve been following the progress of this series, you’ll know that the integrated 2009 Edition with amendment 1 for EN ISO 11607-1, “Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems,” was issued last month. The release of the Part 2 completes the adoption of the ISO amendments released earlier this year.
To review the technical content of each of the amendments for ISO 11607-1 and ISO 11607-2, check out my previous blog for a review: http://standardsforum.document-center.com/amendments-update-iso-11607-series. The EN adoptions contain these changes as issued by ISO.
If you use the two standards and are certified for the European market, you’ll want to get your copies of the new EN ISO 11607-2 revision. You’ll have some choices. Here’s what’s available from Document Center, along with general purchasing information to help you decide which is right for you:
BS EN ISO 11607-2, Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
This British national adoption of the EN ISO 11607-2 is available in paper format only. The price is the highest of any national adoption we sell. However, it is the official English language edition.
SIS EN ISO 11607-2, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)
This is the Swedish edition of the EN ISO 11607-2. It’s available in English, in paper format, for pdf download, and as part of our Standards Online multi-user access subscription service. The price is the lowest of all the adoptions we sell, and the document was released first. The content is identical to the BS EN ISO 11607-2 except for the differences in the cover sheet material. That is, the EN English language edition is actually released by CEN and published as is in all the English language copies.
DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
This is the German national adoption. As of today, the amending material is only available as a “draft” copy as DIN moves through it’s national adoption process. We’ll expect to see the new consolidated edition out soon, with copies available in English as well as German. FYI: The documents are available from Document Center in both paper format and for pdf download. Prices are usually lower than for the BS Editions, but higher than the Swedish.
So as you see, you have a number of options for procuring your copies of the EN ISO 11607 series. Order online at our webstore, www.document-center.com. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ve been helping folks like you since 1982. Make us your Standards Experts!
