SIST EN 455-4:2009

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

5 Test methods 5.1 Real time shelf life determination The test method for the determination of shelf life using real time studies shall be that given in Annex A or a suitably validated method that has been shown to be equivalent to Annex A. If the real time data indicates a shorter shelf life than that claimed on the basis of accelerated ageing the manufacturer shall notify the relevant regulatory authorities. The manufacturer shall change the shelf life claims for SIST EN 455-4:2009

Method for the determination of shelf life by real time stability studies A.1 Principle Gloves in consumer packages are conditioned at the temperature as defined by the manufacturer (e.g. 25 °C) for the intended shelf life period and then tested for compliance.
NOTE 25 °C is the mean kinetic temperature for temperate climates. A.2 Procedure A sufficient number of gloves (taken from a minimum of three lots of gloves packed in their consumer packaging or, in the case of sterile gloves, the peelpack) shall be placed in a specified environment and conditioned to assess at intervals of one year or less: a) median of the Force at Break (13 gloves per interval) according to EN 455-2,
b) freedom from holes according to according to EN 455-1, c) that the glove is fit for the intended purpose, and d) pack integrity (sterile gloves). The lots shall be tested individually and the results for each lot reported individually – lots may not be combined. Each lot must pass all the requirements of the test to allow a shelf life claim for the stated interval. NOTE It is strongly recommended that additional gloves be conditioned as spares in case there is a need for any retesting or in case additional time points are required. A.3 Confirmation of shelf life claim Upon completion of A.2, the shelf life claim shall be up to that period, not to exceed five years, for which the gloves have complied with the requirements of this European Standard.
Guidance on conducting and analyzing accelerated ageing studies B.1 Principle Accelerated ageing studies may be used to estimate provisional shelf lives. This informative annex describes a general protocol that may be used for conducting accelerated ageing studies to estimate shelf life for market introduction while real time studies are in progress. It also offers g
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