60.60 Standard published Feb 6, 2013
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
Published
ISO 20072:2009 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 pre-metered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). This International Standard applies to both refillable and disposable devices intended for personal use.
ISO 20072:2009 is intended for device design verification and not for drug product quality assessment. The objective of this International 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.
Legislation related to this standard
WITHDRAWN
EN ISO 20072:2010
PUBLISHED
EN ISO 20072:2013
60.60
Standard published
Feb 6, 2013
