Standard Svensk standard · SS-EN ISO 20072:2013

Konstruktion och verifiering av inhalatorer för läkemedelsaerosoler - Krav och provningsmetoder (ISO 20072:2009)

Status: Gällande

Omfattning
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.

Ämnesområden

Utrustning för anestesi, respiration och återupplivning (11.040.10)


Produktinformation

Språk: Engelska

Framtagen av: Förbrukningsmaterial inom sjukvården, SIS/TK 330

Internationell titel: Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)

Artikelnummer: STD-98316

Utgåva: 2

Fastställd: 2013-06-05

Antal sidor: 60

Ersätter: SS-EN ISO 20072:2010