ISO 11607 Requirements change for 2019 - New Packaging Standards for Medical Devices
Both sections one and two of ISO 11607 Packaging for terminally sterilized medical devices, have been revised this year. The changes are mostly subtle, the biggest is (maybe) the addition of user evaluation of the sterile seal opening procedure and re-validation requirements.
Both Part 1: Requirements for materials, sterile barrier systems and packaging systems; and,
Part 2: Validation requirements for forming, sealing and assembly processes, have been updated.
The usability additions to part 1 are intended to ensure that package contents can reliably be aseptically accessed. Studies can be conducted under ‘real use’ or simulated conditions, but should consider the environment of use.
Stability and performance remain very important aspects of sterile barrier packaging, which must be challenged. Hazards listed for packaging include: shock and vibration, compression, temperature, humidity, mode of transportation and pressure changes. Real time stability testing is obligatory (with accelerated ageing allowed to fill the gap whilst natural ageing is in process).
It is stated that renewed testing should be applied following: design changes, changes to contents of packs, packaging materials, or other revisions that might influence the seal strength or integrity including changes to handling, storage and transit.
All of these aspects of the testing and validation can be examined at MET.
In section two the annexed list of tests has been revised and updated. Notable is the absence of ISTA 2A as a performance test.
There is also a new annex concerning environmental considerations and new guidance on ways to allow end users to differentiate a sterile barrier system from protective packaging.
ISO 11607-2 does now make an obligatory requirement for validation of the sealing of the sterile barrier system in agreement with ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes.