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1、BRITISH STANDARD BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing The European Standard EN 13532:2002 has the status of a British Standard ICS 11.100 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 13532:2002 This British Sta
2、ndard, 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 BSI 8 May 2002 ISBN 0 580 39682 7 National foreword This British Standard is the official
3、 English language version of EN 13532:2002. 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-refer
4、ences The British Standards 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 Catal
5、ogue. A British Standard 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 tex
6、t; present to the responsible 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
7、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. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13532 Apr
8、il 2002 ICS 11.100 English version General requirements for in vitro diagnostic medical devices for self-testing Exigences gnrales relatives aux dispositifs mdicaux de diagnostic in vitro destins des auto-diagnostics Allgemeine Anforderungen an In-vitro-Diagnostika zur Eigenanwendung This European S
9、tandard was approved by CEN on 27 December 2001. 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 concer
10、ning 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, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own lan
11、guage 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, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sw
12、eden, Switzerland 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 Member
13、s. Ref. No. EN 13532:2002 E EN 13532:2002 (E) 2 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 publi
14、cation of an identical text 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 supp
15、orts 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
16、 countries are bound to implement 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. EN 13532:2002 (E) 3 1Scope This Europea
17、n Standard specifies general 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-te
18、sting. 2Normative 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 references, subsequent amendments to or
19、 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 376, Information supplied by the manufacturer with in vitro diagn
20、ostic reagents for self-testing. EN 592, Instructions for use for in vitro diagnostic instruments for self-testing. EN 1658, Requirements for marking of in vitro diagnostic instruments. EN 13612, Performance evaluation of in vitro diagnostic medical devices. EN 61010-1:2001, Safety requirements for
21、electrical equipment for measurement, control and laboratory use Part 1: General requirements (IEC 61010-1:2001). EN 61326, Electrical equipment for measurement, control and laboratory use EMC requirements (IEC 61326:1997). 3Terms and definitions For the purposes of this European Standard, the follo
22、wing terms and 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 t
23、he examination 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 pot
24、ential recipients, 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 consid
25、ered to be an in 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 per
26、son individual 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 function
27、s, supply voltage, particular warnings. EN 13532:2002 (E) 4 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 s
28、imilar environments by a lay person who will relate the result of the test to him- or herself EN 376:2002 4Design criteria 4.1Ergonomic 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
29、users; ease 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 int
31、ended. 4.2Electromagnetic compatibility EN 61326 shall apply, if relevant. 4.3Protection against electric shock EN 61010-1:2001, clause 6, shall apply, if relevant. 4.4Protection against mechanical hazards EN 61010-1:2001, clause 7, shall apply, if relevant. 4.5Mechanical resistance to shock, vibrat
32、ion and impact EN 61010-1:2001, clause 8, shall apply, if relevant. EN 13532:2002 (E) 5 4.6Equipment temperature exposure limits EN 61010-1:2001, clause 10, shall apply. 4.7Resistance to heat EN 61010-1:2001, clause 10 as well as 12.3 and 12.4, shall apply. Additionally, it shall be taken into accou
33、nt that heat may be generated by natural sunlight and other visible light sources. 4.8Resistance to moisture and liquids EN 61010-1:2001, 11.1, 11.2 and 11.3, shall apply. 4.9Protection against liberated gases, explosion and implosion EN 61010-1:2001, 13.1 and 13.2, shall apply, if relevant. 4.10Com
34、ponents EN 61010-1:2001, 14.1, 14.4, 14.5 and 14.6, shall apply. 4.11Risk 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. travel, hotel); limitations of skil
35、ls 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 of acceptability which, because they are d
36、etermined 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 assessment of the indications and contra-indicat
37、ions for the use of a particular IVD MD for self-testing. 4.12Design 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 information supplied by the manufacturer if ignor
38、ing such changes could lead to erroneous results; EN 13532:2002 (E) 6 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. 5Markings and information supplied by the manufacturer 5.1Markings and labels of IVD
39、 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 appropriate, e. g. if not noted in the instructions for
40、 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 instructions for use. Where an IVD MD for self-testing involves t
41、he use of a reagent, reagent product, calibrator, control material, kit and/or other consumables, these elements shall be labelled according to EN 376. 5.2Instructions for use of IVD MDs for self-testing Any instructions for use of instruments shall be in accordance with the requirements given in EN
42、 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. 6Performance evaluation EN 13612 shall apply. 7User verification User verification, if reasonably possible, shall
43、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 immediately before, during, or immediately after the execution of the respect
44、ive 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 the verification indicates an invalid result. EN 13532:2002 (E) 7 Ann
45、ex 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 essential requirements o
46、f 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.1, are likely to support requirements of the EU Directive 98/79/EC. Complian
47、ce 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.1 Correspondence between this European Standard and EU Directive 98/79/EC Clauses/subclauses of this European Standard E
48、ssential requirements of EU Directive 98/79/EC Qualifying remarks/notes 4.1B.3.3.1, B.3.6, B.7, B.7.1, B.7.2, B.8.7 (t) 4.2B.3.3, B.6.2 4.3B.3.3.2, B.6.3, B.6.4.4 4.4B.3.3.1, B.6.4 4.5B.6.4.2 4.6B.3.3.2 4.7B.3.3.2 4.8B.1.2 4.9B.3.4 4.10B.3.1 4.11A.1, A.2, A.4, A.5 5.1B.8, B.8.4 5.2B.8, B.8.7, 7B.7.2
49、, B.8.7 (t) EN 13532:2002 (E) 8 Bibliography EN 1441, Medical devices Risk analysis. EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2000). blank BS EN 13532:2002 BSI 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 Charter. Revisions British Standard