SIST EN 455-4:2009

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

Name：SIST EN 455-4:2009   Standard name：Medical gloves for single use - Part 4: Requirements and testing for shelf life determination Standard number：SIST EN 455-4:2009   language：English language Release Date：09-Sep-2009   technical committee：VAZ - Healthcare Drafting committee：   ICS number：11.140 - Hospital equipment

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische Handschuhe zum einmaligen Gebrauch - Teil 4: Anforderungen und Prüfung zur Bestimmung der MindesthaltbarkeitGants médicaux non réutilisables - Partie 4: Exigences et essais relatifs à la détermination de la durée de conservationMedical gloves for single use - Part 4: Requirements and testing for shelf life determination11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 455-4:2009SIST EN 455-4:2009en,fr,de01-oktober-2009SIST EN 455-4:2009SLOVENSKI
STANDARD



SIST EN 455-4:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 455-4July 2009ICS 11.140 English VersionMedical gloves for single use - Part 4: Requirements and testingfor shelf life determinationGants médicaux non réutilisables - Partie 4: Exigences etessais relatifs à la détermination de la durée deconservationMedizinische Handschuhe zum einmaligen Gebrauch - Teil4: Anforderungen und Prüfung zur Bestimmung derMindesthaltbarkeitThis European Standard was approved by CEN on 20 June 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 455-4:2009: ESIST EN 455-4:2009



EN 455-4:2009 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references .53Terms and definitions .54Requirements .64.1General .64.2Shelf life and resistance to degradation .74.3Product changes.74.4Labelling .74.5Sterile barrier integrity .74.6Storage conditions .75Test methods .75.1Real time shelf life determination .75.2Accelerated shelf life determination .86Test report .8Annex A (normative)
Method for the determination of shelf life by real time
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