BS EN 13640-2002 Stability testing of in vitro diagnostic reagents.pdf
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1、BRITISH STANDARD BS EN 13640:2002 Stability testing of in vitro diagnostic reagents The European Standard EN 13640:2002 has the status of a British Standard ICS 11.100 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 13640:2002 This British Standard, having been prepared
2、under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 3 May 2002 BSI 3 May 2002 ISBN 0 580 39653 3 National foreword This British Standard is the official English language version of
3、 EN 13640:2002. The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards
4、which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “ International Standards Correspondence Index” , or by using the “ Find” facility of the BSI Standards Electronic Catalogue. A British Standard
5、does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the respons
6、ible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title
7、 page, pages 2 to 10, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13640 March 2002 ICS 11.100 Engli
8、sh version Stability testing of in vitro diagnostic reagents Essais de stabilit des ractifs de diagnostic in vitroHaltbarkeitsprfung von Reagenzien fr in-vitro- diagnostische Untersuchungen This European Standard was approved by CEN on 27 December 2001. CEN members are bound to comply with the CEN/C
9、ENELEC Internal Regulations which stipulate the conditions for giving 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 Management Centre or to any
10、CEN member. This European Standard exists in three official 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 Management Centre has the same status as the official versions. CEN m
11、embers are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE N
12、ORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2002 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13640:2002 E EN 13640:2002 (E) 2 Foreword This document EN 13640:2002 has been p
13、repared by Technical Committee 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 September 2002, and confli
14、cting national standards shall be withdrawn at the latest by September 2002. 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(s). For relationship with EU Directive(s),
15、 see informative annex ZA, which is an integral part of this document. Annexes A and ZA are for information only. This standard includes a Bibliography. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Euro
16、pean Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. ? EN 13640:2002 (E) 3 1 Scope This European Standard is applicable to the stabilit
17、y testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating stabil
18、ity data in the determination of IVD reagent shelf-life including transport stability; determination of stability of the IVD reagent in use after the first opening of the primary container (e. g. on-board stability); monitoring of stability of IVD reagents already placed on the market; verification
19、of stability after IVD reagent modifications that may affect stability. This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles. 2 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply. 2.1 accelerated
20、stability study stability study designed to increase the rate of chemical or physical degradation of an in vitro diagnostic reagent by using exaggerated conditions with the purpose of predicting the shelf-life NOTE The design of an accelerated study may include elevated temperature, high humidity, l
21、ight and vibration. 2.2 batch lot defined amount of material, either starting material, intermediate or finished product, which is uniform in its properties and has been produced in one process or series of processes EN 375:2001 2.3 expiry date date up to which product performance is assured by the
22、manufacturer based on the stability of the IVD reagent EN 375:2001 2.4 in vitro diagnostic reagent IVD reagent in vitro diagnostic medical device which is a reagent, reagent product, calibrator, control material or kit NOTE 1 For the definition of an in vitro diagnostic medical device see Bibliograp
23、hy. NOTE 2 In some cases a particular IVD reagent, as defined for use in human medicine, may serve also in veterinary medicine. EN 375:2001 ? EN 13640:2002 (E) 4 2.5 real-time stability testing exposing the IVD reagent to the conditions anticipated by the manufacturer to which an IVD reagent is expo
24、sed during transportation, storage and use, and investigating robustness and stability under these conditions 2.6 shelf life period until expiry date EN 375 : 2001 2.7 stability ability of an IVD reagent, when kept under specified conditions, to retain throughout the shelf life its properties and/or
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