ISO 20072:2009
Current
The latest, up-to-date edition.
Aerosol drug delivery device design verification — Requirements and test methods
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
28-07-2009
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.
| DevelopmentNote |
Supersedes ISO/DIS 20072. (07/2009)
|
| DocumentType |
Standard
|
| Pages |
43
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| NF EN ISO 20072 : 2013 | Identical |
| NBN EN ISO 20072 : 2013 | Identical |
| NEN EN ISO 20072 : 2013 | Identical |
| NS EN ISO 20072 : 2013 | Identical |
| I.S. EN ISO 20072:2013 | Identical |
| PN EN ISO 20072 : 2013 | Identical |
| BS EN ISO 20072:2013 | Identical |
| EN ISO 20072:2013 | Identical |
| DIN EN ISO 20072:2013-10 | Identical |
| BS EN ISO 20072:2010 | Identical |
| UNE-EN ISO 20072:2011 | Identical |
| UNE-EN ISO 20072:2013 | Identical |
| NEN ISO 20072 : 2009 | Identical |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.