DIN EN ISO 20072:2011-01

The standard applies to the design, labelling, instructions for use and testing requirements for hand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or premetered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). This standard applies to both refillable and disposable devices intended for personal use. The standard is intended for device design verification and not for drug product quality assessment. The objective of this standard is to verify, by laboratory (in-vitro) testing, that the ADDD design consistently meets the manufacturer's design specification by satisfying a device functionality profile and system verification test both of which are determined from a risk assessment and evaluated in accordance with the instructions for use. This standard has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN) with the participation of German experts. At DIN, the German Institute for Standardization e. V., the responsible Committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") of the Medical Standards Committee (NAMed).