1、BSI Standards PublicationBS EN ISO 23640:2015In vitro diagnostic medicaldevices Evaluation ofstability of in vitro diagnosticr e a g e n t sBS EN ISO 23640:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 23640:2015. It is identical to ISO 23640:2011. It
2、 supersedes BS EN ISO 23640:2013 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessary
3、provisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 90814 9ICS 11.100.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was publ
4、ished under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 23640 June 2015 ICS 11.100.10 Supersedes EN ISO 23640:2013English Version In vitro diagnost
5、ic 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-Diagnostika - Haltbarkeitsprfung von Reagenzien fr in-vitro-diagnostische Un
6、tersuchungen (ISO 23640:2011) 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 national standard without any alteration. Up-to-date lis
7、ts 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 version in any other language made by translation under
8、 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yu
9、goslav 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 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROP
10、EN 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 23640:2015 EBS EN ISO 23640:2015EN ISO 23640:2015 (E) 3 Fo
11、reword 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 23640:2015 by Technical Committee CEN/TC 140 “In vitr
12、o 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 December 2015, and conflicting national standards shall be withdrawn at the l
13、atest by June 2018. 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 23640:2013. This document has been
14、 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. The following referenced documents
15、 are indispensable for the application of this document. For undated references, the edition of the referenced 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 use
16、r should always check that any referenced document has not been superseded and that its relevant contents can 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 cor
17、responding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed 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 normat
18、ive references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard 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 organizatio
19、ns 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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
20、 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 23640:2015 without any modification. BS EN ISO 23640:2015EN ISO 23640:2015 (E) 4 Annex ZA (
21、informative) Relationship between this European Standard 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 a means of conforming to Essential Requ
22、irements of Directive 98/79/EC in 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 give
23、n in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA Regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the r
24、isk management process needs to be in compliance with Directive 98/79/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers polic
25、y for determining acceptable risk must be in compliance with essential requirements Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the
26、 core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Directive 98/79/EC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 98
27、/79/EC Qualifying remarks/notes 4.1, 4.2, 4.3, 5.1, 5.2, 5.3 A.4 This Standard covers stability evaluations of diverse transport, storage and use conditions that are foreseen by the IVD manufacturer based on the intended purpose and the anticipated use of the device. In case of self-testing devices,
28、 the tested conditions should reflect the normal routine conditions of use by a lay-user. Particular storage, transport and/or handling conditions must be specified by the IVD manufacturer as provided on the label and in the instructions for use. WARNING Other requirements and other EU Directives ma
29、y be applicable to the product(s) falling within the scope of this standard. BS EN ISO 23640:2015ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carr
30、ied out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
31、ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare Internatio
32、nal Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elem
33、ents of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 23640 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.ISO 23640:2011(E) ISO 2011 All rights
34、reserved iiiBS EN ISO 23640:2015IntroductionOne important aspect of the development and manufacture of in vitro diagnostic (IVD) medical device reagents 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 d
35、etermine shelf life, transport stability, and in-use stability, the manufacturer performs an evaluation. In order to provide this important information to the customer, the manufacturer identifies critical factors that might influence stability of the IVD reagent and carefully evaluates these charac
36、teristics. 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 determine and monitor stability of IVD reagents to ensure that performance characteristics of the product are maintained. This is bes
37、t accomplished by developing a stability evaluation protocol, and producing valid data and analysis to establish appropriate shelf life, transport 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
38、in vitro diagnostic reagents2.ISO 23640:2011(E)iv ISO 2011 All rights reservedBS EN ISO 23640:2015INTERNATIONAL 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 evalu
39、ation 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
40、 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 IVD r
41、eagent 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 stab
42、ility. 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 rec
43、eptacles, 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 a
44、mendments) 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 degrad
45、ation, 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 r
46、elationship 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 23640:20153.3batchlotdefined amount of material that is uniform in its properties and has been produced in one process or series of processesIS
47、O 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 the
48、 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.IS
49、O 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 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 diagnos
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