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

for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.