International Standard
ISO 20072:2009
Aerosol drug delivery device design verification — Requirements and test methods
Reference number
ISO 20072:2009
Edición 1
2009-08
International Standard
Vista previa
ISO 20072:2009
41989
No disponible en español
Publicado (Edición 1, 2009)
Esta norma se revisó y confirmó por última vez en 2020. Por lo tanto, esta versión es la actual.

ISO 20072:2009

ISO 20072:2009
41989
Idioma
Formato
CHF 173
Convertir Franco suizo (CHF) a tu moneda

Resumen

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.

Informaciones generales

  •  : Publicado
     : 2009-08
    : Norma Internacional confirmada [90.93]
  •  : 1
     : 43
  • ISO/TC 84
    11.040.10 
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