UNI EN 455-4 : 2009
Current
The latest, up-to-date edition.
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
Ascertains requirements for shelf life for medical gloves for single use. Also ascertains the requirements for labelling and the disclosure of information relevant to the test methods used.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Standards | Relationship |
| EN 455-4:2009 | Identical |
| ISO 2578:1993 | Plastics Determination of time-temperature limits after prolonged exposure to heat |
| ISO 11346:2014 | Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use |
| EN ISO 2578:1998 | Plastics - Determination of time-temperature limits after prolonged exposure to heat (ISO 2578:1993) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 291:2008 | Plastics Standard atmospheres for conditioning and testing |
| EN ISO 291:2008 | Plastics - Standard atmospheres for conditioning and testing (ISO 291:2008) |
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