EN ISO 20072:2013
Current
The latest, up-to-date edition.
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
02-06-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
6 Test methods
7 Test report
8 Information supplied by the manufacturer
Annex A (informative) - Rationale for requirements
Annex B (informative) - Further guidance and clarification of
the device functionality profile
Annex C (informative) - Rationale for test methods
Annex D (informative) - Two-sided tolerance limit factors (k)
Annex E (informative) - Alternative acceptance criteria for
the device functionality profile
evaluation
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on Medical Devices
Bibliography
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.
Committee |
CEN/TC 205
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Standards | Relationship |
NEN EN ISO 20072 : 2013 | Identical |
NS EN ISO 20072 : 2013 | Identical |
PN EN ISO 20072 : 2013 | Identical |
BS EN ISO 20072:2013 | Identical |
UNI EN ISO 20072 : 2013 | Identical |
NF EN ISO 20072 : 2013 | Identical |
UNE-EN ISO 20072:2013 | Identical |
ISO 20072:2009 | Identical |
DIN EN ISO 20072:2013-10 | Identical |
NBN EN ISO 20072 : 2013 | Identical |
I.S. EN ISO 20072:2013 | Identical |
SN EN ISO 20072 : 2013 | Identical |
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