IEC 61010-2-101-2002 Particular requirements for in vitro diagnostic (IVD) medical equipment
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D6E629DBB5294372B0C31FD76B8CCF6C |
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文件大小(MB)： |
0.19 |
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页数： |
24 |
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日期： |
2008-7-9 |
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文本摘录（文本识别可能有误，但文件阅览显示及打印正常，pdf文件可进行文字搜索定位）：
NORME,INTERNATIONALE,CEI,IEC,INTERNATIONAL,STANDARD,61010-2-101,Première édition,First edition,2002-01,Règles de sécurité pour appareils électriques,de mesurage, de régulation et de laboratoire –,Partie 2-101:,Prescriptions particulières pour les appareils,médicaux de diagnostic in vitro (DIV),Safety requirements for electrical equipment,for measurement, control and laboratory use –,Part 2-101:,Particular requirements for in vitro diagnostic,(IVD) medical equipment,Numéro de référence,Reference number,CEI/IEC 61010-2-101:2002,PUBLICATION GROUPéE DE SéCURITé,GROUPED SAFETY PUBLICATION,61010-2-101 粕 IEC:2002 – 3 –,CONTENTS,FOREWORD..5,1 Scope and object..9,2 Normative references ..11,3 Terms and definitions ..11,4 Tests 13,5 MARKING and documentation.15,6 Protection against electric shock 23,7 Protection against mechanical HAZARDS..23,8 Mechanical resistance to shock and impact ..23,9 Protection against the spread of fire .25,10 Equipment temperature limits and resistance to heat 25,11 Protection against HAZARDS from fluids 25,12 Protection against radiation, including laser sources, and against sonic and,ultrasonic pressure 25,13 Protection against liberated gases, explosion and implosion.27,14 Components .27,15 Protection by interlocks ..27,16 Measuring circuits .27,Annex H Index of defined terms 29,Annex AA (normative) Risk management .31,Annex BB (normative) Instructions for use for self-test IVD medical equipment.35,Bibliography.43,61010-2-101 粕 IEC:2002 – 5 –,INTERNATIONAL ELECTROTECHNICAL COMMISSION,____________,SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR,MEASUREMENT, CONTROL AND LABORATORY USE –,Part 2-101: Particular 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,international 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 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 conditions 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 National 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 unification, 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.,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 International Standard may be the subject,of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.,International Standard IEC 61010-2-101 has been prepared by IEC technical committee 66:,Safety of measuring, control and laboratory equipment.,This standard has been prepared in close collaboration with Working Group CENELEC,BTTF 88.1.,It has the status of a group safety function, as specified in IEC Guide 104.,The text of this standard is based on the following documents:,FDIS Report on voting,66/261/FDIS 66/271/RVD,Full information on the voting for the approval of this standard can be found in the report on,voting indicated in the above table.,This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.,This part 2 is intended to be used in conjunction with IEC 61010-1. It was established on the,basis of the second edition (2001). Consideration may be given to future editions ……
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