Name: UNI EN 455-4 : 2009
Brand: UNI

MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION

Published date

10-08-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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
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)