DIN EN ISO 20072:2013-10

The standard applies to the design, labelling, instructions for use and testing of hand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or pre-metered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). It 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 design of aerosol drug delivery devices consistently meets the manufacturer's design specification by satisfying both 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. In Annex ZA the new edition of DIN EN ISO 20072 takes into account the current provisions of the European Commission regarding the contents and structure of Table ZA.1. 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) and with the participation of German experts. At DIN e. V., the German Institute for Standardisation, the responsible Working Committee is NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at the Medicine Standards Committee (NAMed).