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1、BRITISH STANDARD BS EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents The European Standard EN 13641:2002 has the status of a British Standard ICS 11.100 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldu
2、n sheffieldun, na, Sun Oct 29 08:52:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 13641:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strateg
3、y Committee on 27 May 2002 BSI 27 May 2002 ISBN 0 580 39780 7 National foreword This British Standard is the official English language version of EN 13641:2002. The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibili
4、ty to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “Internati
5、onal Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users of this publication are responsible for their correct application. Co
6、mpliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor rela
7、ted 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 page, pages 2 to 8, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the docum
8、ent was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13641 May 2002 ICS 11.100 English version Elimination or redu
9、ction of risk of infection related to in vitro diagnostic reagents Elimination ou rduction du risque dinfection relatif aux ractifs de diagnostic in vitro Eliminierung oder Herabsetzung des von Reagenzien fr in- vitro-diagnostische Untersuchungen ausgehenden Infektionsrisikos This European Standard
10、was approved by CEN on 5 January 2002. 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 lists and bibliographical references concerning such
11、national standards may be obtained on application to the 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 the responsibility of a CEN member into its own language and
12、notified to the Management Centre has the same status as the official versions. CEN members 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, Swit
13、zerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION 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
14、. EN 13641:2002 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13641:2002 (E) 2 Foreword This document EN 13641:2002 has been prepared by Technical Committee CEN/TC 140 “In vitro diagnostic medical devices“, the secretariat of which is
15、 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 November 2002, and conflicting national standards shall be withdrawn at the latest by November 2002. This document has been prepared u
16、nder 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), see informative annex ZA, which is an integral part of this document. This standard includes a Bibliography.
17、According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norw
18、ay, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13641:2002 (E) 3 Introduction Although medical laboratory staff routinely handle specimens that are potentially infectious an
19、d appropriate protective measures and safety procedures have to be followed, according to the provisions of the Directive 98/79/EC on in vitro diagnostic medical devices (IVD MDs) (see Bibliography, 1) the additional risk of accidental infection caused by IVD MDs containing infectious or potentially
20、 infectious material is to be reduced to a minimum. This requirement of the EU Directive is an essential requirement relating to the design and manufacture of IVD MDs. Manufacturers are obliged to ensure by appropriate design features and manufacturing procedures that the risk of infection presented
21、 by the product itself is minimal. The EU Directive does not specifically address the following aspects which are covered by specific international, European and/or national legislation: general aspects of workers protection and the measures that have to be implemented when infectious or potentially
22、 infectious materials are handled in laboratories or manufacturing sites, transportation of infectious goods, disposal routes and processes. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13641:2002 (E) 4 1 Scope This European Standard s
23、pecifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic
24、 reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is
25、a risk of human infection. The standard does not apply to the following: instruments and specimen receptacles; NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment is addressed in other relevant International and/or European Standards. general aspects
26、of workers protection; transportation of infectious goods; disposal measures. NOTE 2 Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information. 2 Normative references This European Standard incorporates by dated or undated referen
27、ce, provisions from other publications. These normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporat
28、ed in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 375, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use. EN 376, Information supplied by the manufacturer with i
29、n vitro diagnostic reagents for self-testing. 3 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply. 3.1 potentially infectious biological material material which might contain infectious viable transmissible agents albeit with a low probabilit
30、y NOTE Potentially infectious biological material includes all human and all animal sourced materials, including the specimens for routine diagnostic examination and biological materials of unknown origin. 3.2 infectious biological material material which is known or highly likely to contain viable
31、microorganisms or other transmissible agents which are known or suspected to cause disease in humans NOTE Other transmissible agents are e.g. prions. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13641:2002 (E) 5 3.3 in vitro diagnostic
32、 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 1. NOTE 2 In some cases a particular IVD reagent, as defined for use in human medicine, may serve al
33、so in veterinary medicine. EN 375:2001 4 Requirements related to design and manufacture 4.1 General In order to eliminate or reduce to a minimum the risk of infection related to IVD reagents the following aspects shall be considered: rationale for using infectious or potentially infectious biologica
34、l material; sourcing and testing requirements (stipulated in material specifications); inactivation or other appropriate measures to reduce the risk of infection; warnings to be given in the information supplied by the manufacturer. 4.2 Use of infectious biological materials or potentially infectiou
35、s biological materials The use of infectious biological materials in IVD reagents shall be avoided as far as possible. If IVD reagents contain such material as an ingredient or component, its use shall be based on a sound scientific or technical rationale. Infectious material may be used only if it
36、is indispensable for the diagnostic purpose of the product (e. g. positive controls, materials needed to utilise relevant antigens or antibodies in the final kit configuration.) The use of potentially infectious biological materials shall be critically questioned in any case (weighing risks against
37、benefit). If either type of material is used, additional measures as specified in 4.3, 4.4 and clause 5 shall be considered to reduce the risk of infection to a minimum. The justification for use of such materials shall be documented. 4.3 Raw material specifications 4.3.1General For all infectious a
38、nd potentially infectious biological materials used in the manufacture of reagents, appropriate specifications shall be defined (including sourcing and testing requirements) in order to control adequately the risk of infection. 4.3.2Sourcing requirements Appropriate procedures for sourcing infectiou
39、s or potentially infectious biological materials shall be established and documented by the IVD reagents manufacturer. Information shall be available on supplier of the raw material; Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13641:2
40、002 (E) 6 type of material (e. g. blood, plasma, serum, tissue, urine, cells); nature of the source (e. g. human, animal, microbial); origin (e. g. geographical site, human donors group); purification procedures and chemical treatments, if performed. 4.3.3Testing requirements Testing of markers for
41、the most relevant infections, such as HIV 1 and HIV 2 antibodies, HCV antibodies and HBsAg shall be performed. As a rule, tests based on CE-Marked IVD reagents shall be used, where available. Other techniques may be used only if their relevant performance characteristics are at least equivalent and
42、documented. In the case of human blood, including plasma and serum, each individual donation shall be tested. If in justified cases testing is performed on pooled material, an appropriately sensitive testing technology shall be used (e. g. PCR or other amplification techniques). Traceability of test
43、 results shall be ensured. A certificate of analysis for the source material may be considered. Only materials found to be non-reactive in the above-mentioned tests shall be used, except when reactive material is indispensable for the diagnostic purpose. Any exception shall be justified and document
44、ed. 4.4 Manufacturing process If infectious biological materials are used, inactivation or other appropriate measures to reduce to a minimum the risk of infection shall be performed unless the performance of the IVD reagent is adversely affected. Adequate evidence on effectiveness and limitations of
45、 such measures shall be available (e. g. use of literature evidence, “state-of-the-art“ procedures, validation data). During the production process appropriate organisational and hygienic measures shall be taken to prevent secondary contamination (in particular cross contamination). Infectious mater
46、ials and IVD reagents containing infectious materials shall be stored and filled in appropriate containers that effectively avoid dissemination of infectious agents. 5 Information supplied by the manufacturer In addition to the requirements specified in EN 375 and EN 376 appropriate statements about
47、 the relevant infection markers tested and the outcome obtained shall be included in the instructions for use. Any warning given shall be appropriate to the particular risk of infection (potential or known) presented by the reagent. Different wording shall be considered for different levels of risk.
48、 For example, in case all the performed tests show no reactivity for the relevant infection markers or an effective treatment has been performed, a very general warning about the residual risk may be sufficient. By contrast, an explicit and very clear warning shall be made if infectious material is
49、present for justified reasons and additional measures shall be suggested to the user to reduce the risk of infection. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13641:2002 (E) 7 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports es
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