EN ISO 23640-2013 2500 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents《体外诊断医疗器械 体外诊断试剂的稳定性评定》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationIn vitro diagnostic medicaldevices Evaluation of stability of in vitro diagnosticreagentsBS EN ISO 23640:2013Copyright European Committee for Standardization Provided by IHS unde

2、r license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-National forewordThis British Standard is the UK implementation of EN ISO 23640:2013. Itsupersedes BS EN ISO 23640:2011 which is withdrawn.The UK participation in its preparation was entrusted to Tec

3、hnical CommitteeCH/212, IVDs.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 provisions of acontract. Users are responsible for its correct application. The British Standards Institution 2

4、013Published by BSI Standards Limited 2013ISBN 978 0 580 82256 8ICS 11.100.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 March 2013.Amendments issued since

5、publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN ISO 23640:2013Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO

6、 23640 February 2013 ICS 11.100.10 Supersedes EN ISO 23640:2011English Version In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) Dispositifs mdicaux de diagnostic in vitro - valuation de la stabilit des ractifs de diagnostic in vitro (ISO

7、23640:2011) In-vitro-Diagnostika - Haltbarkeitsprfung von Reagenzien fr in-vitro-diagnostische Untersuchungen (ISO 23640:2011) This European Standard was approved by CEN on 8 January 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for gi

8、ving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three of

9、ficial versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies

10、of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain

11、, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN nati

12、onal Members. Ref. No. EN ISO 23640:2013: EBS EN ISO 23640:2013Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN ISO 23640:2013 (E) 2 Contents Page Foreword . 3 Annex ZA (inform

13、ative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC 4 BS EN ISO 23640:2013Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-E

14、N ISO 23640:2013 (E) 3 Foreword The text of ISO 23640:2011 has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 23640:2013 by Technical Comm

15、ittee CEN/TC 140 “In vitro diagnostic 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 August 2013, and conflicting national standards shal

16、l be withdrawn at the latest by August 2013. 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 document supersedes EN ISO 23640:201

17、1. 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 EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According

18、 to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Gre

19、ece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 23640:2011 has been approved by CEN as EN ISO 23640:2013 with

20、out any modification. BS EN ISO 23640:2013Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN ISO 23640:2013 (E) 4 Annex ZA (informative) Relationship between this European Standa

21、rd and the Essential Requirements of EU Directive 98/79/EC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 98/79/EC on i

22、n vitro diagnostic medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers, within

23、the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 98/79/EC on in vitro diagnostic medical devices Clauses/subcla

24、uses of this European Standard Essential Requirements of the Directive 98/79/EC Qualifying remarks/Notes 4.1, 4.2, 4.3, 5.1, 5.2, 5.3 A.4 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 23640:2013Copyright Eu

25、ropean Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IntroductionOne important aspect of the development and manufacture of in vitro diagnostic (IVD) medical device reagents is initially designin

26、g the stability of a product, then determining and verifying the expiry date of the product that is placed on the market. To determine shelf life, transport stability, and in-use stability, the manufacturer performs an evaluation. In order to provide this important information to the customer, the m

27、anufacturer identifies critical factors that might influence stability of the IVD reagent and carefully evaluates these characteristics. Stability of the IVD reagent affects the performance of the device and therefore has an impact on patient results.It is the manufacturers responsibility to determi

28、ne and monitor stability of IVD reagents to ensure that performance characteristics of the product are maintained. This is best accomplished by developing a stability evaluation protocol, and producing valid data and analysis to establish appropriate shelf life, transport limitations and in-use stab

29、ility information, which are then provided to the customers.The basis for this ISO standard is EN 13640, Stability testing of in vitro diagnostic reagents2.ISO 23640:2011(E)iv ISO 2011 All rights reservedBS EN ISO 23640:2013Copyright European Committee for Standardization Provided by IHS under licen

30、se with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-INTERNATIONAL STANDARD ISO 23640:2011(E)In vitro diagnostic medical devices Evaluation of stability of in vitro diagnostic reagents1 ScopeThis International Standard is applicable to the stability evaluatio

31、n of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. This International Standard can also be applied to specimen collection devices that contain substances used to preserve samples or to ini

32、tiate reactions for further processing of the sample in the collection device.This International Standard specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in: the establishment of IVD reage

33、nt shelf life, including transport conditions suitable to ensure that product specifications are maintained; the establishment of stability of the IVD reagent in use after the first opening of the primary container;EXAMPLE On-board stability, stability after reconstitution, open vial/bottle stabilit

34、y. the monitoring of stability of IVD reagents already placed on the market; the verification of stability specifications after modifications of the IVD reagent that might affect stability.This International Standard is not applicable to instruments, apparatus, equipment, systems or specimen recepta

35、cles, or the sample subject to examination.2 Normative referencesThe 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 amend

36、ments) applies.ISO 14971, Medical devices Application of risk management to medical devices3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1accelerated stability evaluationstudy designed to increase the rate of chemical and/or physical degradatio

37、n, or change, of an IVD reagent by using stress environmental conditions to predict shelf lifeNOTE The design of an accelerated stability evaluation can include extreme conditions of temperature, humidity, light or vibration.3.2Arrhenius plotmathematical function that describes the approximate relat

38、ionship between the rate constant of a chemical reaction and the temperature and energy of activationCLSI EP25-A ISO 2011 All rights reserved 1BS EN ISO 23640:2013Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permit

39、ted without license from IHS-,-,-3.3batchlotdefined amount of material that is uniform in its properties and has been produced in one process or series of processesISO 18113-1:2009, definition 3.53.4batch codelot numberdistinctive set of numbers and/or letters that specifically identifies a batch an

40、d permits its manufacturing, packaging, labelling and distribution history to be tracedISO 18113-1:2009, definition 3.63.5expiry dateexpiration dateupper limit of the time interval during which the performance characteristics of a material stored under specified conditions can be assuredNOTE Expiry

41、dates are assigned to IVD reagents, calibrators, control materials and other components by the manufacturer based on experimentally determined stability properties.ISO 18113-1:2009, definition 3.173.6IVD medical devicein vitro diagnostic medical devicedevice, used alone or in combination, intended b

42、y the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, which can include reagents, calibrators, control materials, specimen receptacles, software, and related instrume

43、nts or apparatus or other articlesISO 18113-1:2009, definition 3.273.7IVD reagentin vitro diagnostic reagentchemical, biological or immunological components, solutions or preparations intended by the manufacturer to be used as an IVD medical deviceISO 18113-1:2009, definition 3.283.8real time stabil

44、ity evaluationstudy designed to establish or verify the shelf life of the IVD reagent when exposed to the conditions specified by the manufacturerNOTE Conditions that can affect stability of an IVD reagent include temperature, transport conditions, vibration, light, humidity.3.9shelf lifeperiod of t

45、ime until the expiry date, during which an IVD reagent, in its original packaging, maintains its stability under the storage conditions specified by the manufacturerNOTE Stability (3.10) and expiry date (3.5) are related concepts.ISO 18113-1:2009, definition 3.66ISO 23640:2011(E)2 ISO 2011 All right

46、s reservedBS EN ISO 23640:2013Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-3.10stabilityability of an IVD medical device to maintain its performance characteristics within the

47、 limits specified by the manufacturerNOTE 1 Stability applies to: IVD reagents, calibrators and controls, when stored, transported and used in the conditions specified by the manufacturer; reconstituted lyophilized materials, working solutions and materials removed from sealed containers (when prepa

48、red, used and stored according to the manufacturers instructions for use).NOTE 2 Stability of an IVD reagent or measuring system is normally quantified with respect to time: in terms of the duration of a time interval over which a metrological property changes by a stated amount; in terms of the change of a property over a stated time interval.ISO 18113-1:2009, definition 3.683.11verificationprovision of objective evidence that a given item fulfils specified requirementsEXAMPLE 1 Confirmation that a given material as claimed is homogeneous for the