1、BRITISH STANDARD klirnination or reduction of risk of infection related to o o 40 o in vitro diagnostic reagents The European Standard EN 13641:2002 has the status ofa British Standard ICs 11.100 BS EN 1364 1 :2002 WkNb A%“ U- rn% E rn NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIG
2、HT LAW $ present to the responsible international/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. - A list of organizations represented on this
3、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 “International Standards Correspondence Index”, or by using t
4、he “Search”faci1ity ofthe BSI Electronic Catalogue or ofBritish Stan dards 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. Compliance with a British Standard does not ofitself co
5、nfer immunity from legal obligations. 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 document was last issued. O BSI 27 May 200
6、2 ISBN O 580 39780 7 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13641 May 2002 ICs 11.100 English version Elimination or reduction of risk of infection related to in vitro diagnostic reagents Elimination ou rduction du risque dinfection relatif aux ractifs de diagnostic in vitro Eliminieru
7、ng oder Herabsetzung des von Reagenzien fr in- vitro-diagnostische Untersuchungen ausgehenden Infektionsrisi kos This European Standard was approved by CEN on 5 January 2002 CEN members are bound to comply with the CENKENELEC Internal Regulations which stipulate the conditions for giving this Europe
8、an 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 CEN member. This European Standard exists in three official versions (English, Fr
9、ench, 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 members are the national standards bodies of Austria, Belgium, Czech Republic, Den
10、mark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION EUROPISCHES KOMITEE FR NORMUNG COMIT EUROPEN DE NORMALISATION Management Centre: rue de Stassart, 3
11、6 B-1050 Brussels O 2002 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13641:2002 E EN 13641 :2002 (E) Foreword This document EN 13641:2002 has been prepared by Technical Committee CEN/TC 140 “In vitro diagnostic medical devices“
12、, 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 November 2002, and conflicting national standards shall be withdrawn at the latest by November 2002. This
13、 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), see informative annex ZA, which is an integral part of this document. This stand
14、ard includes a Bibliography. According to the CENICENELEC 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, Luxembo
15、urg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. 2 EN 13641 :2002 (E) Introduction Although medical laboratory staff routinely handle specimens that are potentially infectious and appropriate protective measures and safety procedures have to be followed,
16、according to the provisions of the Directive 98/79/EC on in vitro diagnostic medical devices (IVD MDs) (see Bibliography, I) the additional risk of accidental infection caused by IVD MDs containing infectious or potentially infectious material is to be reduced to a minimum. This requirement of the E
17、U 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 by the product itself is minimal. The EU Directive does not specifically add
18、ress 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 infectious materials are handled in laboratories or manufacturing sites, -
19、transportation of infectious goods, - disposal routes and processes. 3 EN 13641 :2002 (E) 1 Scope This European Standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, c
20、alibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materia
21、ls of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is 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
22、materials throughout such equipment is addressed in other relevant International and/or European Standards. - general aspects 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
23、are listed in Bibliography for information. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated r
24、eferences, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 375, Information supplied b
25、y the manufacturer with in vitro diagnostic reagents for professional use. EN 376, Information supplied by the manufacturer with in 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 potential
26、ly infectious biological material material which might contain infectious viable transmissible agents albeit with a low probability NOTE Potentially infectious biological material includes all human and all animal sourced materials, including the specimens for routine diagnostic examination and biol
27、ogical materials of unknown origin. 3.2 infectious biological material material which is known or highly likely to contain viable microorganisms or other transmissible agents which are known or suspected to cause disease in humans NOTE Other transmissible agents are e.g. prions. 4 EN 13641 :2002 (E)
28、 3.3 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 I. NOTE 2 In some cases a particular IVD reagent, as defined for use in huma
29、n medicine, may serve also 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 potent
30、ially infectious biological 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 mat
31、erials or potentially infectious 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 m
32、aterial may be used only if it 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 an
33、y case (weighing risks against 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.
34、3.1 General For all infectious and 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. 4.3.2 Sourcing requirements Appropriate
35、procedures for sourcing infectious 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; 5 EN 13641 :2002 (E) -type of material (e. g. blood, plasma, serum, tissue, urine,
36、 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. 4.3.3 Testing requirements Testing of markers for the most relevant infections, such as HIV 1 and HIV 2 antibodie
37、s, HCV antibodies and HB,Ag 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 documented. In the case of human blood, including plasma and se
38、rum, 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 am pl if ication techniques) . Traceability of test results shall be ensured. A certificate of analysis for th
39、e 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 documented. 4.4 Manufacturing process If infectious biological mate
40、rials 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 such measures shall be available (e. g. use of literature
41、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 materials and IVD reagents containing infectious materials shall
42、 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 the relevant infection markers tested and the outcome obta
43、ined 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. For example, in case all the performed tests show no react
44、ivity 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 present for justified reasons and additional measures shall
45、 be suggested to the user to reduce the risk of infection. 6 EN 13641 :2002 (E) Clauses/subclauses of this European Standard 4.1 4.2 Annex ZA (informative) Corresponding essential requirements of Qualifying remarkdNotes Directive 98/79/EC A. 1, A.2, B.2.1 B.2.1, B.2.2 Clauses of this European Standa
46、rd addressing essential requirements or other provisions of EU Directives 4.3.2 4.3.3 4.4 This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of the EU Directive 98/79/EC. B.2.2,
47、 B.2.5 B.2.1, B.2.2 B.2.1, B.2.2 WARNING Other requirements and other EU Directives mav be applicable to the product(s) falling within the scope of this standard. The following clauses of this standard, as detailed in Table ZA.l, are likely to support requirements of the EU Directive 98/79/EC. Compl
48、iance with these clauses of this standard provides one means of conforming to the specific essential requirements of the Directive concerned and associated EFTA regulations. Table ZA.l - Correspondence between this European Standard and Directive 98/79/EC I I 4.3.1 I B.2.2 15 I B.8.4 (j), B.8.7 (q),
49、 B.8.7 (s) 7 EN 13641 :2002 (E) Bibliography EN 12442-1, Animal tissues and their derivatives utilized in the manufacture of medical devices - Part I: Analysis and management of risk. EN 12442-2, Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling. EN 12442-3, Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents. Directive 98/79/EC of the European
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