ISO 11608 All New for 2022
ISO 11608-1 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems now contains more design validation information on
· Test programmes required
· Sample numbers to test
· Stability time points
· The application of statistics
· The requirement to consider uncertainty of measurement.
· The applicability of usability studies
· The application of ISO 10993 bicompatibility
· The need to consider drug / container interactions.
There are some changes to the definitions of injector systems and how the dose accuracy limits are applied and a mention of how this may be influenced when mixing is required.
The standard still works in tandem with ISO 11040-8, which takes responsibility for standalone PFSs. In particular deliverable volume measurement is deferred, even this is not dealt with in detail in ISO 11040, which defers in turn to pharmacopieas.
It is very flexible to accommodate a wide variety of combination devices, some not yet dreamed up. However, it does not take responsibility for continuous infusion devices such as pumps which are covered by IEC 60601-2-24 and ISO 28620. There are also a number of other exclusions, largely for things which have their own specific standard.
It is now spelt out that each validation relates only to the formulation used and repeat validation is required for different formulations supplied in the same injector.