SS-EN-ISO-20072 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)

SS-EN-ISO-20072 - 2013 EDITION - CURRENT
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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.

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Designation Name

SS-EN ISO 20072:2013

Revision Level

2013 EDITION

Status

Current

Publication Date

June 5, 2013

Language(s)

English

Page Count

60

International Equivalent

EN ISO 20072:2013(IDT); ISO 20072:2009(IDT)