Developed by the International Standards Organization (ISO), the ISO 20072 standard describes the design verification, basic safety and performance characteristics and test methods of aerosol drug delivery equipment. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 20072 Design verification of aerosol drug delivery device - Features and test methods.
This standard describes the design, labeling, instructions for use and testing requirements for hand-held, single and multi-use aerosol drug delivery devices for delivering a metered or pre-measured aerosolized drug via the respiratory tract, including nasal, oral, tracheal, bronchial and alveolar regions. This international standard applies to refillable and single-use devices for personal use.
The ISO 20072 standard has been developed for device design verification, not for drug design quality assessment. The purpose of this standard is to verify with laboratory testing that the design of aerosol drug delivery devices consistently meets the manufacturer's design specification. To achieve this, it provides a device functionality profile and system validation test method, both of which are determined and evaluated by a risk assessment.
There are times when this standard is covered by the ISO 27427 standard. The intended use of aerosol drug delivery devices and the risk assessment of the device determine which international standard the manufacturer has chosen for design verification. Briefly, this standard describes the process of determining the design verification of aerosol drug delivery devices along with a risk-based device functionality profile with a drug, placebo, or a representative drug.
Our organization also provides businesses with laboratory services, including ISO 20072 aerosol drug delivery equipment design verification, basic safety and performance specifications, and testing services.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
