SIST EN 455-4:2009

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

This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

Medizinische Handschuhe zum einmaligen Gebrauch - Teil 4: Anforderungen und Prüfung zur Bestimmung der Mindesthaltbarkeit

Dieser Teil der EN 455 legt Anforderungen an Haltbarkeitsdauer von medizinischen Handschuhen zum
einmaligen Gebrauch fest. Darüber hinaus werden die Anforderungen an die Kennzeichnung und die
Offenlegung der für die verwendeten Prüfverfahren relevanten Informationen festgelegt.
Diese Norm gilt für bestehende, neue und wesentlich veränderte Ausführungen. Für bestehende
Ausführungen, für die zur Zeit keine Alterungsdaten zur Verfügung stehen, sind diese Daten innerhalb eines
angemessenen Zeitraums zu erstellen.

Gants médicaux non réutilisables - Partie 4: Exigences et essais relatifs à la détermination de la durée de conservation

La présente partie de l’EN 455 spécifie les exigences relatives à la durée de conservation des gants médicaux non réutilisables. Elle spécifie également les exigences relatives à l’étiquetage et à la diffusion des informations concernant les méthodes d’essai utilisées.
La présente Norme européenne s’applique aux conceptions existantes, nouvelles et modifiées de manière significative. En ce qui concerne les conceptions existantes pour lesquelles aucune donnée de vieillissement n’est actuellement disponible, ces données doivent être obtenues dans un délai raisonnable.

Medicinske rokavice za enkratno uporabo - 4. del: Zahteve in preskusi za določanje roka uporabnosti

General Information

• Status: Published
• Publication Date: 09-Sep-2009
• ICS: 11.140 - Hospital equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 14-Aug-2009
• Due Date: 19-Oct-2009
• Completion Date: 10-Sep-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 455-4:2009 - Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

Standards Content (Sample)

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
...