Norm

ISO/DIS 20072:2008 en

Aërosol drug delivery ontwerpverificatie - Eisen en beproevingsmethoden

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Over deze norm

Status Ontwerp
Aantal pagina's 49
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 31-07-2008
Taal Engels
This International Standard 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 premetered aerosolized medications to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). This includes both refillable and disposable devices intended for personal use. This 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 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. ADDDs, with their medication are described herein and are referred to as "combination products" in that they are designed to be used with a specific active pharmaceutical ingredient. The standard excludes continuous or semi-continuous aerosolization devices covered in ISO 27427 'Respiratory therapy and other equipment - Nebulizing systems and components', aerosolization devices which do not emit API, general purpose aerosolization devices (for use with ventilators), and atomizers.

Details

ICS-code 11.040.10
Nederlandse titel Aërosol drug delivery ontwerpverificatie - Eisen en beproevingsmethoden
Engelse titel Aerosol drug delivery device design verification - Requirements and test methods
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