Our industry spends a lot of time around ISO 11607, the well-established standard for the packaging of terminally sterilized medical devices. Continual change across the global community can make it challenging to deliver timely and coherent technical guidance. A look back at the evolution of ISO 11607 is a great way to learn from the past while forging a healthy tomorrow.
A Rocky Start
The early 1990s saw an ISO Technical Committee (TC) Work Group (WG) assemble (ISO TC 198 WG7). The group was tasked with drafting a new standard for terminally sterilized medical packaging that would harmonize the contents of EN 868-1 with ANSI/AAMI/ISO 11607. Carried out, industry would operate under a single, unified terminally sterilized medical device standard. This failed, at least in part, when comprehensive alignment of the two standards was not reached. The intent was that harmonization efforts would reconvene in the future.
A Regroup and Remedy
Once published, it became apparent that ISO 11607 was being largely ignored by the European community, and beyond. An ANSI/AAMI work group wrote a 1998 Technical Information Report to clarify what was required to comply with ISO 11607. What eluded discovery and perpetuated the rule’s shortcomings, however, was that the document did not present an accurate picture of the packaging development process. Two years later, ISO released an update offering guidance on how to ensure users were in compliance with EN 868-1, further confounding manufacturers. By that time, one thing was clear: Work Group 7 needed to reconvene, and they did. The reinvented document met the original objectives to harmonize, define and inform. Now in two parts, Part 1 would encompass design and materials guidance, while Part 2 would address the package assembly process and validation. At last, a global standard achieved.
A Path Forward
In the years since ISO 11607-1:2006 and -2:2006, the industry has better understood both mandated requirements (indicated by “shall” statements) and discretionary (“should”) practices.
As most industry professionals are aware, ISO has also adhered to its policy of periodic reviews (~five years) to ensure that the standard reflects current concerns, emerging changes and addresses gaps. Revisions to the 2006 standard were finalized in 2014 and again in the most current iteration, ISO 11607-1:2019 and ISO 11607-2:2019. (For UK users, the British Standards Institute completed their review process of the 2019 changes in 2020, resulting in the EN BS ISO 11607-1:2020 and ISO 11607-2:2020 nomenclature you may see published from outside the US).
A Quick Look
Through an overall lens, both parts of the standard were reviewed for harmonization opportunities with the EU MDR’s General Safety and Performance Requirements. The GSPR calls for design considerations that integrate ease of use features, safe handling features that avert microbial contamination, and provide proof of packaging integrity that is visibly evident to the end user. The updates include:
- Usability evaluation for aseptic presentation requirements NEW
- Revalidation content NEW
- Environmental content Annex NEW
- Protective packaging vs sterile barrier differentiation Annex NEW
- Usability considerations UPDATED
- Microbiological packaging performance UPDATED
- Test methods (additions and deletions) UPDATED
Additionally, a new version of ISO/TS (Technical Specification) 16775 was written to guide users in navigating the ISO 11607-1 and -2 standard. Of particular interest is the clause-by-clause guidance, greatly enhancing usability as a companion tool. The TS 16775 includes new topic-based Annexes related to health care facilities and related areas that would benefit from additional instruction.
If the five-year review intervals remain on track, the industry will see the next edition take shape in 2024. For now, it’s rewarding to realize how far we’ve come.
