Standard name: Aerosol drug delivery device design verification. Requirements and test methods (ISO 20072:2009).
Applicable medical devices:
This standard applies to hand-held single- and multi-use aerosol drug delivery devices (ADDD) both refillable and disposable intended to intended to deliver a metered or premetered aerosolized medication. It excludes continuous or semi-continuous aerosolization devices covered in ISO 27427, aerosolization devices which do not emit active pharmaceutical ingredient (API), general purpose aerosolization devices (for use with ventilators) and atomizers
The standard specifies the design, labelling, instructions for use, quality and performance requirements – along with the test methods to assess these elements.
Testing capabilities to ISO 20072 include:
- Visual inspection - stored data, settings, dose or indications, markins, and freedom from defects
- System verification test at standard atmosphere and nominal flow rate
- Dose accuracy and emitted mass - when subjected to standard, cool and hot atmospheres
- Dose accuracy and emitted mass - after being subjected to dry heat storage preconditioning
- Dose accuracy and emitted mass - after being subjected to cold storage preconditioning
- Lifetime test
- Preconditioning of pen injectors in dry heat atmosphere, cold storage atmosphere, cyclical atmosphere, by free fall, vibration, shock and for damp heat and the influence of leakage.
In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing program to meet your specific testing requirements and resolve and design or functionality issues you might have.
Please note: The information outlined above is to be used as a reference. Please refer to the appropriate competent standards agency in your country for full details and implementation of ISO 20072.
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