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SSH EN ISO 20072:2013

Pajisje e projektuar për verifikimin e dhënies se barit me aerosol - Kërkesat dhe metodat e testimit (ISO 20072:2009)

Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
23 pri 2014

General information

60.60     23 pri 2014

DPS

DPS/KT 205

European Norm

11.040.10  

anglisht  

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Scope

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.

Related directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 20072:2010

NOW

PUBLISHED
SSH EN ISO 20072:2013
60.60 Standard published
23 pri 2014

Related project

Adopted from EN ISO 20072:2013