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UNI EN 455-4 : 2009
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The latest, up-to-date edition.
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MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
08-10-2009
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
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