ISO 11607 and EN 868 - Status of Medical Packaging Standards Development

20.3.2016

Jaana Kilpinen, Product Manager

We have a few major standards to follow in the Health sector:

  • ISO 11607 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11607 - Part 2: Validation requirements for forming, sealing and assembly processes
  • EN 868 series of product specific standards to cover papers and Tyvek® used in manufacturing sterile barrier systems, our pouches and rolls made under the Steriking® brand and sterilization wraps 

A few years ago, there was a Systematic Review (once every 5 years) of the EN 868 series of standards. Based on the comments received at the time, there was a need to revise them all. However, as there are 9 standards belonging to this group, it was decided to initially revise first half of them and to confirm the other half for future revision for time being. The ballot comments were resolved at the meeting in Berlin last November. The first half is now expected to be published in mid-2016 after the formal vote which has just finished, with the other half of the standards being subsequently opened for revision. This is expected to happen this year after the new secretariat for the working group (CEN/TC 102/WG 4) has been announced. Finland has proposed to take the secretariat responsibility from DIN in order to assist the working group in finalizing the EN 868 series of revisions.
 
In addition, the parent documents of ISO 11607 were also both under Systematic Review in 2015. The working group (ISO/TC 198/WG 7) met in Berlin in December in order to discuss the results of the review. After discussion and the resolution of the comments received, the working group still decided to undertake the revision of both parts. The committee drafts are now opened for comments. New versions of the ISO 11607 standards are expected to be published in first half of 2019. All in all, it is expected that it will take three years to accomplish all the steps.
 
The new revisions of ISO 11607 will have a direct impact on ISO/TS 16775:2014 (the guidance document of these two standards), which will then need to be revised after the newest editions of ISO 11607-1 and ISO 11607-2 are published. And, when the process is finally repeated, it will most probably be time again to have a Systemic Review of the EN 868 standards. Development cannot be prevented.