UNI EN 455-4 : 2009

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Current The latest, up-to-date edition.

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

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Published date: 07-10-2009

Publisher: Ente Nazionale Italiano di Unificazione (UNI)

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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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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.

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Committee	CT 44
Document Type	Standard
ISBN
Pages
Published
Publisher	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
EN 455-4:2009	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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)

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