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Homepage>CSN Standards>85 HEALTH SERVICE>8500 Medical instruments and apparatus>CSN EN ISO 20072 - Aerosol drug delivery device design verification - Requirements and test methods
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CSN EN ISO 20072 - Aerosol drug delivery device design verification - Requirements and test methods

CSN EN ISO 20072

Aerosol drug delivery device design verification - Requirements and test methods

CURRENCY
LANGUAGE
English
Category:850003
Released:2009
Released:2013
Number of Standard:CSN EN ISO 20072
DESCRIPTION

EN ISO 20072


EN ISO 20072 Aerosol drug delivery device design verification - Requirements and test methods - 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.

Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.