I.S. EN 455-4:2009
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Test report
Annex A (normative) - Method for the determination of
shelf life by real time stability
studies
Annex B (informative) - Guidance on conducting and
analyzing accelerated ageing
studies
Annex C (informative) - Determination of the shelf life
of a significantly modified
product
Annex ZA (informative) - Relationship between this
European Standard and the
Essential Requirements of EU
Directive 93/42/EEC Medical
Devices
Bibliography
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