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ISO 20072:2009

Aerosol drug delivery device design verification — Requirements and test methods
28. 7. 2009.

Опште информације

90.93     10. 6. 2025.

ISO

ISO/TC 84

Međunarodni standard

11.040.10  

engleski   francuski  

Kupovina

Objavljen

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Apstrakt

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.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 20072:2009
90.93 Odluka o potvrđivanju standarda
10. 6. 2025.

Nacionalna preuzimanja

SRPS EN ISO 20072:2013  
ISS

Verifikacija projektovanja inhalatora — Zahtevi i metode ispitivanja

95.99   Povučen

Z076 Saznaj više

SRPS EN ISO 20072:2014  
ISS

Verifikacija dizajna sredstva za primenu lekova u obliku aerosola — Zahtevi i metode ispitivanja

60.60   Standard objavljen

Z076 Saznaj više