EN 455-4:2009

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

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 Europäische Norm gilt für bestehende, neue und wesentlich veränderte Ausführungen. Für bestehende
Ausführungen, für die zurzeit keine Alterungsdaten zur Verfügung stehen, sollten diese Daten innerhalb eines
angemessenen Zeitraums erstellt werden.
Diese Europäische Norm legt keine Chargengröße fest. Es wird auf die Schwierigkeiten verwiesen, die mit der
Verteilung und Kontrolle sehr großer Chargen verbunden sein können. Die empfohlene maximale Einzelchargengröße
für die Herstellung beträgt 500 000.

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, il convient d’obtenir ces données dans un délai raisonnable.
La présente Norme européenne ne spécifie pas la taille d’un lot. L'attention est attirée sur les difficultés qui
peuvent être associées à la distribution et au contrôle de lots de très grande taille. La taille maximale
recommandée pour un lot de production est de 500 000.

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

General Information

• Status: Published
• Publication Date: 28-Jul-2009
• Withdrawal Date: 30-Jan-2010
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 3 - Medical gloves
• Current Stage: 9060 - Closure of 2 Year Review Enquiry - Review Enquiry
• Start Date: 02-Dec-2024
• Completion Date: 02-Dec-2024
• 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: SIST 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
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

Method for the determination of shelf life by real time stability studies .9Annex B (informative)
Guidance on conducting and analyzing accelerated ageing studies . 10Annex C (informative)
Determination of the shelf life of a significantly modified product . 17Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Devices . 18Bibliography . 19 SIST EN 455-4:2009

 Part 1: Requirements and testing for freedom from holes  Part 2: Requirements and testing for physical properties  Part 3: Requirements and testing for biological evaluation  Part 4: Requirements and testing for shelf life determination This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive 93/42/EEC. For relationship with EC Directive 93/42/EEC, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom. SIST EN 455-4:2009

1 Scope 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. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 455 (all parts), Medical gloves for single use
EN 1041, Information supplied by the manufacturer of medical devices EN ISO 11607 (all parts), Packaging for terminally sterilized medical devices 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 Arrhenius equation relation between the activation energy (EA), the absolute temperature (T), and the rate constant of a degradation reaction [k(T)] NOTE The shelf life of a rubber product is predicted based on the Arrhenius principle of chemical reaction rates. The Arrhenius equation has the basic form: RTEAeATk−⋅=)(
where A = constant (min-1),
EA = Activation Energy (J/mol),
R = the Universal Gas Constant (8,314 J · mol-1 · K-1),
T = Absolute Temperature (K),
k(T) (min-1) is the rate constant for the degradation process.
An alternate way of expressing the Arrhenius equation is: SIST EN 455-4:2009

3.5 shelf life time from date of manufacture to the claimed expiry date 3.6 significant change change that could reasonably be expected to impact the safety or effectiveness of a medical device NOTE It could include a change to any of the following:
a) the manufacturing process, facility or equipment;
b) the manufacturing quality control procedures, including the methods, tests or procedures used to control the quality, purity and sterility of the device or of the materials used in its manufacture;
c) the design of the device, including its performance characteristics, principles of operation and specifications of materials; and
d) the intended use of the device, including any new or extended use, any addition or deletion of a contra-indication for the device and any change to the period used to establish its expiry date.
3.7 threshold value maximum or minimum value for a property being tested 4 Requirements 4.1 General Medical gloves shall comply with the requirements of the EN 455 series of standards until the end of their stated shelf life provided they are stored according to the instructions supplied by the manufacturer. Manufacturers shall test the properties that are reasonably expected to alter over the shelf life of the product. These properties shall include, but are not limited to, force at break, freedom from holes and, in the case of sterile gloves, pack integrity. This European Standard defines the methods to determine shelf life of medical gloves before any new product or products for which there has been a significant change to formulation or process can be marketed. SIST EN 455-4:2009
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