EN 455-4-2009 en Medical gloves for single use - Part 4 Requirements and testing for shelf life determination《一次性医用手套 第4部分 货架寿命测定的要求和试验》.pdf

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1、BS EN 455-4:2009ICS 11.140NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDMedical gloves forsingle usePart 4: Requirements and testing forshelf life determinationThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee o

2、n 31 August2009 BSI 2009ISBN 978 0 580 58298 1Amendments/corrigenda issued since publicationDate CommentsBS EN 455-4:2009National forewordThis British Standard is the UK implementation of EN 455-4:2009.The UK participation in its preparation was entrusted to TechnicalCommittee CH/205/3, Medical glov

3、es.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom

4、legal obligations.BS EN 455-4:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 455-4July 2009ICS 11.140English VersionMedical gloves for single use - Part 4: Requirements and testingfor shelf life determinationGants mdicaux non rutilisables - Partie 4: Exigences etessais relatifs la dterminatio

5、n de la dure deconservationMedizinische Handschuhe zum einmaligen Gebrauch - Teil4: Anforderungen und Prfung 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 co

6、nditions 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 thre

7、e 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 Aust

8、ria, 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 COMMITT

9、EE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 455-4:2009: EBS EN 455-4:2009EN 455-4:2009 (E

10、) 2 Contents Page Foreword 3Introduction .41 Scope .52 Normative references .53 Terms and definitions 54 Requirements 64.1 General 64.2 Shelf life and resistance to degradation 74.3 Product changes.74.4 Labelling 74.5 Sterile barrier integrity .74.6 Storage conditions .75 Test methods 75.1 Real time

11、 shelf life determination .75.2 Accelerated shelf life determination .86 Test 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) Determ

12、ination 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 . 19BS EN 455-4:2009EN 455-4:2009 (E) 3 Foreword This document (EN 455-4:2009) ha

13、s 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 conflicti

14、ng 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 E

15、N 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

16、 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

17、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 followi

18、ng 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, Sloven

19、ia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 455-4:2009EN 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

20、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

21、 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 s

22、urveillance 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. BS EN 455-4:2009EN 455-4:2009 (E) 5 1 Scope Thi

23、s 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

24、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 re

25、commended 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 docume

26、nt (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 f

27、ollowing 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 rate

28、s. 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 Arr

29、henius equation is: BS EN 455-4:2009EN 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 gl

30、oves 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, man

31、ufactured 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 b

32、e 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, p

33、urity 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 de

34、letion 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 t

35、he 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 br

36、eak, 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. BS EN 455-4:200

37、9EN 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 tim

38、e 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 marke

39、t 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 s

40、helf 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

41、 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 labe

42、lling 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 mi

43、ght 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 Ma

44、nufacturers 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

45、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 sh

46、elf life claims for BS EN 455-4:2009EN 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 r

47、eal 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 durati

48、on 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) Complet

49、e 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. BS EN 455-4:2009EN 455-4:2009