NA 176

DIN Standards Committee Health Technologies

Standards [Withdrawn]

DIN EN ISO 20072
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009); German version EN ISO 20072:2010

Title (German)

Ausführungsverifizierung von Inhalationsgeräten - Anforderungen und Prüfverfahren (ISO 20072:2009); Deutsche Fassung EN ISO 20072:2010

Overview

The 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 medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). This standard applies to both refillable and disposable devices intended for personal use. The 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. This standard has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN) with the participation of German experts. At DIN, the German Institute for Standardization e. V., the responsible Committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") of the Medical Standards Committee (NAMed).

Document: references other documents

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 84 - Devices for administration of medicinal products and catheters  

Edition 2011-01
Original language German
Translation English
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Table of contents

Contact

Dipl.-Ing. (FH)

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