SIST EN 455-4:2009
(Main)Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
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. 2 Normative references.
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
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 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
EN 455-4:2009 (E) 3 Foreword This document (EN 455-4:2009) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2010, and conflicting national standards shall be withdrawn at the latest by January 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This part of EN 455 gives requirements and test methods for shelf life determination of medical gloves as part of a risk management process, in accordance with EN ISO 14971. EN 455 consists of the following parts under the general title "Medical gloves for single use":
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
EN 455-4:2009 (E) 4 Introduction Medical Gloves are intended to be a barrier to agents responsible for the transmission of infections. In order to help ensure effectiveness, it is essential that gloves fit the hand properly, are free from holes and have adequate physical strength so as not to fail during use. All these issues are addressed in the EN 455 series. This European Standard covers the minimum properties that address certain essential requirements detailed in the Medical Devices Directive (93/42/EEC). Manufacturers are required to conduct stability tests to estimate the shelf life of any new or modified glove before the product is placed on the market and to initiate real time stability studies. The real time stability test can be considered as part of the manufacturers' requirement to conduct post-marketing surveillance on their products. These requirements are intended to ensure that manufacturers have adequate data to support shelf life claims before products are placed on the market and that these data are available for review by regulatory authorities. SIST EN 455-4:2009
EN 455-4:2009 (E) 5
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
EN 455-4:2009 (E) 6 )(ln)(lnRTEATkA−= The time required for the physical properties to deteriorate to the threshold value is inversely proportional to the rate constant k(T). 3.2 consumer package package, intended for distribution to a consumer, containing loose gloves or individual pairs of gloves NOTE For example a primary pack (peelpack) for sterile product or a dispenser box for non-sterile product. 3.3 expiry date stated date after which the gloves shall not be used 3.4 lot collection of gloves of the same design, colour, shape, size and formulation, manufactured at essentially the same time, using the same process, raw materials of the same specifications, common equipment and packed in the same type of individual container
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
EN 455-4:2009 (E) 7 Since it is impracticable to complete real time ageing studies before introducing products to the market, accelerated stability studies based on kinetic principles can be used to assign a provisional shelf life. Such provisional shelf lives assigned shall be verified by real time studies. Shelf life claims based on accelerated ageing shall not exceed three years. Data supporting the shelf life claims made by the manufacturer shall be made available on request. 4.2 Shelf life and resistance to degradation Before a new or significantly modified product is placed on the market this European Standard requires: a completed real time study as described in 5.1 to determine shelf life or a real time study as described in 5.1 to determine shelf life shall have commenced and an accelerated ageing study as described in 5.2 shall have been completed. It is recommended that the shelf life should be determined at the specific storage conditions specified for the product by the manufacturer (e.g. 25 °C). The manufacturer shall state the temperature along with the shelf life or expiry date. Accelerated ageing studies (5.2) shall be carried out on gloves from the same production lots as used for real time determination of shelf life (5.1). NOTE For guidance on mean kinetic temperature see EN ISO 291. 4.3 Product changes Whenever there is any significant change to the product the manufacturer shall re-determine shelf life. 4.4 Labelling At the end of the shelf life the labelling shall remain readable according to EN 1041. 4.5 Sterile barrier integrity For sterile products the requirements of EN ISO 11607 series apply. Attention is drawn to the maintenance of the sterility for the given shelf life of the product. NOTE Depending on the utilised packaging material, it might occur that the packaging material will not withstand certain elevated temperatures that are being used to predict the shelf life by means of accelerated ageing testing. In these cases it might be advisable to conduct the accelerated ageing testing at lower temperatures. 4.6 Storage conditions Manufacturers shall provide storage instructions to the end user. These may be printed on the consumer package or supplied in an accompanying document.
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
EN 455-4:2009 (E) 8 the product to one based upon the real time study. For gloves placed on the market, real time stability studies shall be completed for the full period of the shelf life claim. 5.2 Accelerated shelf life determination Pending the completion of real time studies, accelerated stability studies shall be used to estimate the shelf life. Examples of methods for accelerated studies and data analysis are provided in Annex B. Data generated from such studies shall support the claim that the gloves fulfil the requirements in Clause 4 for the duration of the labelled shelf life at temperature as determined by the manufacturer. NOTE Guidance for selection of temperature is given in EN ISO 2578. 6 Test report The test report shall contain at least the following information: a) Reference to the appropriate standards; b) Sample details: 1) Complete identification of the material tested; 2) Dimensions and method of the preparation of the test pieces, with reference to relevant European Standards; 3) Selected properties, with reference to relevant European Standards; 4) Threshold value of the selected property; 5) Times and temperatures of the conditioning of test pieces; c) Details of the ageing conditions; d) Test data and analysis according to the relevant standards; e) Confirmed shelf life claim. SIST EN 455-4:2009
EN 455-4:2009 (E) 9 Annex A (normative)
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.
SIST EN 455-4:2009
EN 455-4:2009 (E) 10 Annex B (informative)
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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