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1、TECHNICAL REPORT IEC TR 61010-3-101 First edition 2003-04 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 3-101: Conformity verification report for IEC 61010-2-101:2002 Particular requirements for in vitro diagnostic (IVD) medical equipment Rgles de scu
2、rit pour appareils lectriques de mesurage, de rgulation et de laboratoire Partie 3-101: Rapport de vrification de la conformit de la CEI 61010-2-101:2002 Prescriptions particulires pour appareils mdicaux de diagnostic in vitro (DIV) Reference number IEC/TR 61010-3-101:2003(E) Copyright International
3、 Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo reproduction or networking permitted without license from IHS -,-,- Publication numbering As from 1 January 1997 all IEC publications are
4、issued with a designation in the 60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1. Consolidated editions The IEC is now publishing consolidated versions of its publications. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the base publ
5、ication incorporating amendment 1 and the base publication incorporating amendments 1 and 2. Further information on IEC publications The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that the content reflects current technology. Information relating to
6、 this publication, including its validity, is available in the IEC Catalogue of publications (see below) in addition to new editions, amendments and corrigenda. Information on the subjects under consideration and work in progress undertaken by the technical committee which has prepared this publicat
7、ion, as well as the list of publications issued, is also available from the following: IEC Web Site (www.iec.ch) Catalogue of IEC publications The on-line catalogue on the IEC web site (http:/www.iec.ch/searchpub/cur_fut.htm) enables you to search by a variety of criteria including text searches, te
8、chnical committees and date of publication. On-line information is also available on recently issued publications, withdrawn and replaced publications, as well as corrigenda. IEC Just Published This summary of recently issued publications (http:/www.iec.ch/online_news/ justpub/jp_entry.htm) is also
9、available by email. Please contact the Customer Service Centre (see below) for further information. Customer Service Centre If you have any questions regarding this publication or need further assistance, please contact the Customer Service Centre: Email: custserviec.ch Tel: +41 22 919 02 11 Fax: +4
10、1 22 919 03 00 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo reproduction or networking permitted without license from IHS -,-,- TECHNICAL REPORT IEC TR 61010-3-
11、101 First edition 2003-04 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 3-101: Conformity verification report for IEC 61010-2-101:2002 Particular requirements for in vitro diagnostic (IVD) medical equipment Rgles de scurit pour appareils lectriques de
12、 mesurage, de rgulation et de laboratoire Partie 3-101: Rapport de vrification de la conformit de la CEI 61010-2-101:2002 Prescriptions particulires pour appareils mdicaux de diagnostic in vitro (DIV) PRICE CODE IEC 2003 Copyright - all rights reserved No part of this publication may be reproduced o
13、r utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Electrotechnical Commission, 3, rue de Varemb, PO Box 131, CH-1211 Geneva 20, Switzerland Telephone: +41 22 919 02 11 Telefax: +41 2
14、2 919 03 00 E-mail: inmailiec.ch Web: www.iec.ch XB For price, see current catalogue Commission Electrotechnique Internationale International Electrotechnical Commission Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=
15、Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo reproduction or networking permitted without license from IHS -,-,- 2 TR 61010-3-101 IEC:2003(E) CONTENTS FOREWORD 3 Conformity verification report for IEC 61010-2-101:2002 . 5 5Marking and documentation .11 6Protection against electric shock15
16、7Protection against mechanical HAZARDS.21 8Mechanical resistance to shock and impact21 9Protection against the spread of fire.22 10Equipment temperature limits and resistance to heat .23 11Protection against HAZARDS from fluids.24 12Protection against radiation, including laser sources, and against
17、sonic and ultrasonic pressure25 13Protection against liberated gases, explosion and implosion 25 14Components.26 15Protection by interlocks27 16Test and measurement equipment .27 Annex F Routine tests27 Annex AA RISK management. .27 Annex BB Instructions for use for self-test IVD medical equipment.2
18、7 Annex XX List of applicable and omitted clauses/subclauses and associated forms in the test report. . 62 Annex YY Details of the changes included in the combined CVR for TR IEC 61010-3-101:2003, to reflect the specific requirements of IEC 61010-2-101:2002 67 Table 1 Documents reviewed 8 Table 2 Te
19、st equipment list . 9 Table 3 List of components and circuits relied on for safety10 Form A.1 to Form 33 28 to 61 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo r
20、eproduction or networking permitted without license from IHS -,-,- TR 61010-3-101 IEC:2003(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE Part 3-101: Conformity verification report for IEC 61010-2-101:2002 Pa
21、rticular requirements for in vitro diagnostic (IVD) medical equipment FOREWORD 1)The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote inte
22、rnational co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted to technical committees; any IEC National Committee interested in the
23、 subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with condi
24、tions determined by agreement between the two organizations. 2)The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested Natio
25、nal Committees. 3)The documents produced have the form of recommendations for international use and are published in the form of standards, technical specifications, technical reports or guides and they are accepted by the National Committees in that sense. 4) In order to promote international unifi
26、cation, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter.
27、5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards. 6) Attention is drawn to the possibility that some of the elements of this Technical Report may be the subject of patent righ
28、ts. The IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report when it has collected data of a different kind fr
29、om that which is normally published as an International Standard, for example “state of the art”. IEC 61010-3-101, which is a technical report, has been prepared by IEC technical committee 66: Safety of measuring, control, and laboratory equipment. The text of this technical report is based on the f
30、ollowing documents: Enquiry draftReport on voting 66/279/DTR66/317/RVC Full information on the voting for the approval of this technical report can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the IEC/ISO Directives, Part 2. Copy
31、right International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo reproduction or networking permitted without license from IHS -,-,- 4 TR 61010-3-101 IEC:2003(E) This report is a Techn
32、ical Report and is of a purely informative nature and is therefore by itself not to be regarded as an International Standard. It is to assist users of the standard with determining and recording verification of conformity of the equipment under test with the requirements of: IEC 61010-2-101: 2002 Th
33、e protocol for completion of this report is contained in publication IEC 61010-3:2003. The IEC sells read-only PDF files as a general rule. In the present instance, and quite exceptionally, to enable the user to fill in the forms, a revisable file is included in a pocket affixed to the back cover of
34、 this publication. This file can also be downloaded from the Web as a PDF file. There is, however, at the end of the document, a revisable file containing the forms. Please use the zip/unzip function. WARNING Experience has shown that if a version is downloaded in Word 97or Word 2000 and is subseque
35、ntly converted to Word 6, some of the symbols may have been incorrectly changed in the conversion. Care must, therefore, be taken to verify the symbols used in the converted document. The committee has decided that the contents of this publication will remain unchanged until 2008. At this date, the
36、publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo reproduction or networking p
37、ermitted without license from IHS -,-,- TR 61010-3-101 IEC:2003(E) 5 TEST REPORT IEC 61010-2-101 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipmemnt Report Reference No : Tested
38、 by (name and signature). : Approved by (name and signature) : Date of issue : Contents : Pages Testing organisation : Address : Testing location : Applicants name. : Address : Test specification: Standard :IEC 610102101 : 2002 / and IEC 61010 1: 2001 (2nd Edition) Copyright blank test report .: Tes
39、t Procedure.: Procedure deviation.: Non-standard test method: This report has been prepared by IEC TC 66, which retains responsibility for any changes or corrections required. Test item description . : Trademark : Model/Type reference : Rating(s) : Copyright International Electrotechnical Commission
40、 Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo reproduction or networking permitted without license from IHS -,-,- 6 TR 61010-3-101 IEC:2003(E) Test item particulars : Type of item tested .: Measurement / Control
41、/ Laboratory Description of equipment function. : INSTALLATION/OVERVOLTAGE CATEGORY : POLLUTION DEGREE. : Environmental rating. : standard / extended (specify): Equipment mobility : portable / hand-held / floorstanding / fixed / built in/ benchmounted/other (specify): Connection to mains supply : Pe
42、rmanent / detachable cord set / non detachable cord set / none Operating conditions. : continuous / short-time / intermittent Overall size of the equipment (L x W x H) : Mass of the equipment (kg) : Marked degree of protection to IEC 60529. : IP_ _ Accessories and detachable parts included in the ev
43、aluation : Options included. : Test case verdicts: Test case does not apply to the test object: N/A Test object does meet the requirement: P(Pass) Test object does not meet the requirement .: F(Fail) General remarks: The test results presented in this report relate only to the item(s) tested. “(see
44、remark #)“ refers to a remark appended to the report. “(see Annex #)“ refers to an annex appended to the report. “(see Form A.#)“ refers to a table appended to the report. Throughout this report a comma (point) is used as the decimal separator. Copyright International Electrotechnical Commission Pro
45、vided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo reproduction or networking permitted without license from IHS -,-,- TR 61010-3-101 IEC:2003(E) 7 Copy of equipment markings : Summary of test results (information/comment
46、s): Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo reproduction or networking permitted without license from IHS -,-,- 8 TR 61010-3-101 IEC:2003(E) TABLE: 1 - Doc
47、uments reviewed Document Name VersionDateEditorAttached Yes / No Page Numbers Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 22:16:49 MSTNo reproduction or networking permitted without license from IHS -,-,- TR 61010-3-101 IEC:2003(E) 9 TABLE: 2 - Test equipment list Calibration date Test equipment number Type and make Unique identification numberLast note 1 Due Ranges used note 2 Comments Note 1Or interval between calibrations Note 2Range used may by noted using the Ins