EN 868-2, Packaging for terminally sterilized medical devices – Part 2: Sterilization wrap – Requirements and test methods, has just been updated. The new 2017 Edition is available now from Document Center Inc. It must be adopted by all European Union countries by August 2017. It replaces the EN 868-2 from 2009.
Medical device sterilization is an important safety requirement. But with the many jurisdictions providing regulatory guidance on this issue, harmonization of requirements often times feels elusive. So those of you using this document will be pleased to know that a major part of the update involves aligning it with the EN ISO 11607 series.
Other modifications have been listed in the Annex A. While not an exhaustive list, it gives you a good idea of where the changes are. It also relates the changes to other EN ISO and EN standards which cover similar requirements or provide needed tests. Some improvements to the standard have also been made for repeatability and reproducibility. Annex B has been deleted. The bibliography has been expanded.
While EN 868-2 is related to the Medical Device Directive (93/42/eec), it has not been formally adopted as a harmonized standard. So you will not find it on the harmonized list nor will the notice of adoption appear in the Official Journal. This means that there is no legal implementation date for you with regards to the EU.
You’ll have a number of purchasing choices for this standard, as is the case with all EN publications. Check our website, www.document-center.com, to see which may be best for your purposes. Here is a link to a search page which displays 5 options for you.
Still have questions? Just get in touch with us here at Document Center Inc. You can reach us by phone (650-591-7600) or email (info@document-center.com). We’ve been working with standards since 1982. Our knowledgeable staff is available to you for any standards questions you may have. We also have a number of products and services that will help you manage your standards collection more effectively. Make us your Standards Experts!
By the way, for those of you using other parts in this series, there are a number of new 2017 Editions available. Here’s the list:
EN 868-2, 2017 Ed., Part 2: Sterilization wrap – Requirements and test methods
EN 868-3, 2017 Ed., Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) – Requirements and test methods
EN 868-4, 2017 Ed., Part 4: Paper bags – Requirements and test methods
EN 868-6, 2017 Ed., Part 6: Paper for Low Temperature Sterilization Processes – Requirements and test methods
EN 868-7, 2017 Ed., Part 7: Adhesive Coated Paper for Low Temperature Sterilization Processes – Requirements and test methods