DIN EN ISO 23640-2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640 2011) German version EN ISO 23640 2015《体外诊断医疗器械 体外诊断试.pdf

1、December 2015 English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.100.10!%Iw1“2388414www.din.d

2、eDIN EN ISO 23640In vitro diagnostic medical devices Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011);English version EN ISO 23640:2015,English translation of DIN EN ISO 23640:2015-12In-vitro-Diagnostika Haltbarkeitsprfung von Reagenzien fr in-vitro-diagnostische Untersuchung

3、en (ISO 23640:2011);Englische Fassung EN ISO 23640:2015,Englische bersetzung von DIN EN ISO 23640:2015-12Dispositifs mdicaux de diagnostic in vitro valuation de la stabilit des ractifs de diagnostic in vitro (ISO 23640:2011);Version anglaise EN ISO 23640:2015,Traduction anglaise de DIN EN ISO 23640:

4、2015-12SupersedesDIN EN ISO 23640:2013-09See start of applicationwww.beuth.deDocument comprises pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.1411.15 DIN EN ISO 23640:2015-12 2 A comma is used as the decimal marker. Start of

5、application The start of application of this standard is 2015-12-01. For DIN EN ISO 23640:2013-09 there is a transition period ending on 2018-06-30. National foreword This document (EN ISO 23640:2015) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagn

6、ostic test systems” in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-03-03 AA Qu

7、alittsmanagement in medizinischen Laboratorien. The DIN Standard corresponding to the International Standard referred to in Clause 2 of this standard is as follows: ISO 14971 DIN EN ISO 14971 Amendments This standard differs from DIN EN ISO 23640:2013-09 as follows: a) the European Foreword and Anne

8、x ZA have been revised. Previous editions DIN EN 13640: 2002-06 DIN EN 23640: 2012-03, 2013-09 National Annex NA (informative) Bibliography DIN EN ISO 14971, Medical devices Application of risk management to medical devices EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 23640 June 2015 ICS

9、 11.100.10 Supersedes EN ISO 23640:2013English 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 23640:2011)In-vitro-Diag

10、nostika - Haltbarkeitsprfung von Reagenzien fr in-vitro-diagnostische Untersuchungen This European Standard was approved by CEN on 3 June 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a n

11、ational 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 official versions (English, French, German). A

12、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 of Austria, Belgium, Bulgaria, Croatia, Cypru

13、s, 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, Sweden, Switzerland, Turkey and United King

14、dom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 236

15、40:2015 E(ISO 23640:2011) Contents Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 General requirements 7 4.1 General principles7 4.2 Protocol 8 4.3 Stability reports 8 5 Procedures .9 5.1 General 9 5.1.1 Purpose .9 5.1.2 Examinations 9 5.1.3

16、Number of batches to be examined .9 5.2 Real time stability evaluation .10 5.2.1 Shelf life 10 5.2.2 Stability during transport 10 5.2.3 In-use stability 10 5.3 Accelerated stability evaluation .10 5.3.1 General 10 5.3.2 Procedure .10 5.3.3 Analysis of data .10 5.3.4 Evaluations and conclusions .10

17、Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC 11 Bibliography 12 2 EN ISO 23640:2015 (E) DIN EN ISO 23640:2015-12 Foreword The text of ISO 23640:2011 has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory

18、testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 23640:2015 by Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN. This European Standard shall be give

19、n the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn at the latest by June 2018. Attention is drawn to the possibility that some of the elements of this document may be

20、 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 23640:2013. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association,

21、and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. The following referenced documents are indispensable for the application of this document. For undated references, the edition of the referen

22、ced document (including any amendments) listed below applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents c

23、an still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as lis

24、ted below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standar

25、d Equivalent dated standard EN ISO ISO 14971 EN ISO 14971:2012 ISO 14971:2007, Corrected version 2007-10-01 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, Cr

26、oatia, 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, Sweden, Switzerland, Turkey and

27、 the United Kingdom. Endorsement notice The text of ISO 23640:2011 has been approved by CEN as EN ISO 23640:2015 without any modification. 3EN ISO 23640:2015 (E) DIN EN ISO 23640:2015-12 IntroductionOne important aspect of the development and manufacture of in vitro diagnostic (IVD) medical device r

28、eagents is initially designing 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 infor

29、mation to the customer, the manufacturer 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 manufactur

30、ers responsibility to determine 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, transpor

31、t limitations and in-use stability information, which are then provided to the customers.The basis for this ISO standard is EN 13640, Stability testing of in vitro diagnostic reagents2.4 EN ISO 23640:2015 (E) DIN EN ISO 23640:2015-12 1 ScopeThis International Standard is applicable to the stability

32、evaluation 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

33、or to initiate 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

34、IVD reagent 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

35、 stability. 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 specime

36、n receptacles, 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

37、any amendments) 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 d

38、egradation, 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 approxim

39、ate relationship between the rate constant of a chemical reaction and the temperature and energy of activationCLSI EP25-A5EN ISO 23640:2015 (E) DIN EN ISO 23640:2015-12 3.3batchlotdefined amount of material that is uniform in its properties and has been produced in one process or series of processes

40、ISO 18113-1:2009, definition 3.53.4batch codelot numberdistinctive set of numbers and/or letters that specifically identifies a batch and permits its manufacturing, packaging, labelling and distribution history to be tracedISO 18113-1:2009, definition 3.63.5expiry dateexpiration dateupper limit of t

41、he time interval during which the performance characteristics of a material stored under specified conditions can be assuredNOTE Expiry dates are assigned to IVD reagents, calibrators, control materials and other components by the manufacturer based on experimentally determined stability properties.

42、ISO 18113-1:2009, definition 3.173.6IVD medical devicein vitro diagnostic medical devicedevice, used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or

43、compatibility purposes, which can include reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articlesISO 18113-1:2009, definition 3.273.7IVD reagentin vitro diagnostic reagentchemical, biological or immunological components, soluti

44、ons or preparations intended by the manufacturer to be used as an IVD medical deviceISO 18113-1:2009, definition 3.283.8real time stability evaluationstudy designed to establish or verify the shelf life of the IVD reagent when exposed to the conditions specified by the manufacturerNOTE Conditions th

45、at can affect stability of an IVD reagent include temperature, transport conditions, vibration, light, humidity.3.9shelf lifeperiod of time until the expiry date, during which an IVD reagent, in its original packaging, maintains its stability under the storage conditions specified by the manufacture

46、rNOTE Stability (3.10) and expiry date (3.5) are related concepts.ISO 18113-1:2009, definition 3.666 EN ISO 23640:2015 (E) DIN EN ISO 23640:2015-12 3.10stabilityability of an IVD medical device to maintain its performance characteristics within the limits specified by the manufacturerNOTE 1 Stabilit

47、y 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 prepared, used and stored according to the manufacturers

48、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 18

49、113-1:2009, 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 quantity value and measurement procedure concerned.EXAMPLE 2 Confirmation that performance properties or requirements of a measuring system are achieved within the specified expiry date.EXAMPLE 3 Confirmation that the magnitude and direction of a consis