EN 455-4:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General
  4.2 Shelf life and resistance to degradation
  4.3 Product changes
  4.4 Labelling
  4.5 Sterile barrier integrity
  4.6 Storage conditions
5 Test methods
  5.1 Real time shelf life determination
  5.2 Accelerated shelf life determination
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