1、BRITISH STANDARD General requirements for in vitro diagnostic medical devices for self- te sting The European Standard EN 13532:2002 has the status of a British Standard ICs 11.100 BS EN 13532:2002 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 13532:2002 Amd.No. Nation
2、al foreword Date Comments 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 Strategy Committee on 8 May 2002 This British Standard is the official English l
3、anguage version of EN 13532:2002. The UKparticipation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility to: - - aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretati
4、on, 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 committee can be obtained on request to its secretary. Cross-references The British Standards which im
5、plement 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 does not pu
6、rport 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 ofitself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front
7、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 8 May 2002 ISBN O 580 39682 7 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13532 April 2002 ICs 11.100 English v
8、ersion General requirements for in vitro diagnostic medical devices for self-testi ng Exigences gnrales relatives aux dispositifs mdicaux de diagnostic in vitro destins des auto-diagnostics Allgemeine Anforderungen an In-vitro-Diagnostika zur Eigenanwendung This European Standard was approved by CEN
9、 on 27 December 2001 CEN members are bound to comply with the CENKENELEC 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
10、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 notified to the Man
11、agement 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, Switzerland and United
12、Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION EUROPISCHES KOMITEE FR NORMUNG COMIT EUROPEN DE NORMALISATION Management Centre: rue de Stassart, 36 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 13532:2002
13、E EN 13532:2002 (E) Foreword This document EN 13532 has been prepared 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
14、or by endorsement, at the latest by October 2002, and conflicting national standards shall be withdrawn at the latest by October 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
15、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. According to the CENICENELEC Internal Regulations, the national standards organizations of the following countries are bound to impl
16、ement this European 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. 2 EN 13532:2002 (E) 1 Scope This European Standard specifies genera
17、l requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing. 2 Normative referenc
18、es 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 references, subsequent amendments to or revisions of any of these
19、 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 376, Information supplied by the manufacturer with in vitro diagnostic reagents for self-te
20、sting. EN 592, Instructions for use for in vitro diagnostic instruments for self-testing. EN 1658, Requirements for marking of in vitro diagnostic instruments. EN 1361 2, Performance evaluation of in vitro diagnostic medical devices. EN 61 O1 0-1 :2001, Safety requirements for electrical equipment f
21、or measurement, control and laboratory use - Part I: General requirements (IEC 61010- 1:2001). EN 61 326, Electrical equipment for measurement, control and laboratory use - EMC requirements (IEC 61326:1997). 3 Terms and definitions For the purposes of this European Standard, the following terms and
22、definitions apply. 3.1 in vitro diagnostic medical device any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination
23、of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning congenital abnormality, or to determine the safety and compatibility with potential recipien
24、ts, or to monitor therapeutic measures NOTE 1 A specimen receptacle, whether vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination is considered to be an i
25、n vitro diagnostic medical device. NOTE 2 Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination. 3.2 lay person individual
26、who does not have specific medical education EN 376:2002 3.3 marking inscription, in writing or as a graphical symbol, permanently affixed to a product NOTE Examples for inscriptions are manufacturers or distributors trademark, model or type number, identification of intended functions, supply volta
27、ge, particular warnings. 3 EN 13532:2002 (E) 3.4 permanently affixed removable only with a tool or by appreciable force and able to withstand the effects of temperature, rubbing, common solvents, reagents, and vapours encountered during normal use 3.5 self-testing use in the home or similar environm
28、ents by a lay person who will relate the result of the test to him- or herself EN 376:2002 4 Design criteria 4.1 Ergonomic and human factor aspects The design of IVD MDs for self-testing shall take the following ergonomic and human factors into consideration: - identification of intended users; - ea
29、se of operation; - ease of user maintenance; - readability of the test results; - ease of interpretation of the instructions for use; -ease of verification by the user of the correct functioning of the IVD MD for self-testing; - reasonably foreseeable variations in the way in which the user performs
30、 the test; - reasonably foreseeable variations in the environment in which the test is performed; - reasonably foreseeable misuse. When taking these factors into account, consideration shall be given to potential limitations in skills and capabilities of users for whom the IVD MD for self-testing is
31、 intended. 4.2 Electromagnetic compatibility EN 61 326 shall apply, if relevant. 4.3 Protection against electric shock EN 61 O1 0-1 :2001, clause 6, shall apply, if relevant. 4.4 Protection against mechanical hazards EN 61 O1 0-1 :2001, clause 7, shall apply, if relevant. 4.5 Mechanical resistance t
32、o shock, vibration and impact EN 61 O1 0-1 :2001, clause 8, shall apply, if relevant. 4 EN 13532:2002 (E) 4.6 Equipment temperature exposure limits EN 61 O1 0-1 :2001, clause IO, shall apply. 4.7 Resistance to heat EN 61010-1:2001, clause 10 as well as 12.3 and 12.4, shall apply. Additionally, it sh
33、all be taken into account that heat may be generated by natural sunlight and other visible light sources. 4.8 EN 61010-1:2001, 11.1, 11.2 and 11.3, shall apply. Resistance to moisture and liquids 4.9 EN 61 O1 0-1 :2001, 13.1 and 13.2, shall apply, if relevant. Protection against liberated gases, exp
34、losion and implosion 4.1 O Components EN 61010-1:2001, 14.1, 14.4, 14.5and 14.6, shall apply. 4.1 1 Risk analysis The manufacturer shall decide on the acceptability of potential risk of such factors as: - unforeseen use of the IVD MD for self-testing in a potentially unsuitable environment (e. g. tr
35、avel, hotel); - limitations of skills and means available to lay users; - limitations of specified performance characteristics; - probability of occurrence of failure; - consequence of a failure; - inappropriate disposal. NOTE This subclause refers to EN 1441. This standard does not stipulate levels
36、 of acceptability which, because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard. This standard is not intended to give detailed guidance on management of risks. Furthermore, it is not intended to cover decision-making processes regarding asses
37、sment of the indications and contra-indications for the use of a particular IVD MD for self-testing. 4.12 Design change Changes to the design of an IVD MD for self-testing which are made after it has been put onto the market and which affect - the specifications; -the performance; -the marking and i
38、nformation supplied by the manufacturer if ignoring such changes could lead to erroneous res u Its; 5 EN 13532:2002 (E) - aspects of safety of the user or a third party shall be regarded as significant. Such changes shall be submitted to risk analysis and evaluation. 5 Markings and information suppl
39、ied by the manufacturer 5.1 Markings and labels of IVD MDs for self-testing Where an IVD MD for self-testing involves the use of an instrument, the marking of the instrument shall be in accordance with EN 1658. In addition, the IVD instruments for self-testing shall bear the following markings, if a
40、ppropriate, e. g. if not noted in the instructions for use of the instrument or on the label or in the instructions for use of the reagents necessary to perform the respective self-testing: - intended purpose; - a statement that the instrument is intended for self-testing; - a reference to the instr
41、uctions for use. Where an IVD MD for self-testing involves the use of a reagent, reagent product, calibrator, control material, kit and/or other consumables, these elements shall be labelled according to EN 376. 5.2 Instructions for use of IVD MDs for self-testing Any instructions for use of instrum
42、ents shall be in accordance with the requirements given in EN 592. Any instructions for use of reagents, reagent products, calibrators, control materials, kits and/or other consumables shall be in accordance with the requirements given in EN 376. 6 Performance evaluation EN 13612 shall apply. 7 User
43、 verification User verification, if reasonably possible, shall allow the user to check at the time of use - correct functioning of the IVD MD for self-testing, i. e. system control, - correct execution of the test including sequence of the procedural steps. NOTE “At the time of use“ means immediatel
44、y before, during, or immediately after the execution of the respective self-test. User verification shall be integrated into the test wherever reasonably possible. User verification should give unambiguous information. The instructions for use shall clearly and in simple terms state what to do if th
45、e verification indicates an invalid result. 6 EN 13532:2002 (E) 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 Eur
46、opean Free Trade Association, and supports essential requirements of the EU Directive 98/79/EC. WARNING: Other requirements and other EU Directives may 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 li
47、kely to support requirements of the EU Directive 98/79/EC. Compliance 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
48、 EU Directive 98/79/EC Essential requirements of EU Directive 98/79/EC Clauses/subclauses of this European Standard Qu al ifyi ng remarkslnotes I 4.1 B.3.3.1, B.3.6, B.7, B.7.1, B.7.2, B.8.7 (t) I 4.2 B.3.3, B.6.2 I 4.3 B.3.3.2, B.6.3, B.6.4.4 1 B.3.3.1, B.6.4 B.6.4.2 I 4.6 B.3.3.2 1 I 4.7 B.3.3.2 I
49、 4.8 B.1.2 I 4.9 B.3.4 1 I 4.10 B.3.1 1 I 4.11 A.l, A.2, A.4, A.5 1 I 5.1 B.8, B.8.4 I 5.2 B.8, B.8.7, B.7.2, B.8.7 (t) 7 EN 13532:2002 (E) Bibliography EN 1441, Medical devices - Risk analysis. EN IS0 14971, Medical devices -Application of risk management to medical devices (IS0 14971:2000). 8 BS EN 13532:2002 B SI 389 Chiswick High Road London w4 4AL BSI -British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Cha
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