IEC 60601-2-65-2012 Medical electrical equipment - Part 2-65 Particular requirements for the basic safety and essential performance of dental intra-oral X-ray e.pdf

1、 IEC 60601-2-65 Edition 1.0 2012-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment Appareils lectromdicaux Partie 2-65: Exigences particulires pour la scur

2、it de base et les performances essentielles des appareils rayonnement X dentaires intra-oraux IEC60601-2-65:2012 colourinsideTHIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced

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16、publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-2-65 Edition 1.0 2012-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment Appa

17、reils lectromdicaux Partie 2-65: Exigences particulires pour la scurit de base et les performances essentielles des appareils rayonnement X dentaires intra-oraux INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE X ICS 11.040.50 PRICE CODE CODE PRIX ISBN 978-2-83220

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19、 un distributeur agr. colourinside 2 60601-2-65 IEC:2012 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 8 201.3 Terms and definitions 8 201.4 General requirements 10 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 Cla

20、ssification of ME EQUIPMENT and ME SYSTEMS 10 201.7 ME EQUIPMENT identification, marking and documents . 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 14 201.10 Protection against unwanted and excessive

21、radiation HAZARDS 14 201.11 Protection against excessive temperatures and other HAZARDS 14 201.12 Accuracy of controls and instruments and protection against hazardous outputs 15 201.13 HAZARDOUS SITUATIONS and fault conditions . 15 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15 201.15 C

22、onstruction of ME EQUIPMENT . 15 201.16 ME SYSTEMS 15 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 15 202 Electromagnetic compatibility Requirements and tests . 15 203 Radiation protection in diagnostic X-ray equipment . 16 Annexes . 26 Annex C (informative) Guide to marking a

23、nd labeling requirements for ME EQUIPMENT and ME SYSTEMS 27 Annex AA (informative) Particular guidance and rationale 28 Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in relation to defined terms in this standard 35 Bibliography 37 Index of defined terms used in th

24、is particular standard 40 Figure AA.1 AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 29 Figure AA.2 AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR. 31 Figure AA.3 Waveform of long IRRADIATION TIME X-RADIATION from a ONE-PEAK X-RAY GENERATOR 32 Figure BB.1 Structure of

25、 DENTAL INTRA-ORAL X-RAY EQUIPMENT 35 Figure BB.2 Parts of DENTAL INTRA-ORAL X-RAY EQUIPMENT 36 Table 201.101 List of potential ESSENTIAL PERFORMANCE to be considered by MANUFACTURER in the RISK MANAGEMENT PROCESS 10 Table 201.C.101 Marking on the outside of ME EQUIPMENT or its parts . 27 Table 201.

26、C.102 Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 27 60601-2-65 IEC:2012 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment FOREWORD 1) The I

27、nternational Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and e

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37、the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 60601-2-65 has been prepared by IEC subcommittee 62B: Diagnostic Imaging Equipment, of IEC technical committee 62: Ele

38、ctrical equipment in medical practice. The text of this particular standard is based on the following documents: FDIS Report on voting 62B/889/FDIS 62B/897/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above tabl

39、e. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. 4 60601-2-65 IEC:2012 In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as no

40、tes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen

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44、 recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or r

45、ationale related to that item in Annex AA. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be

46、 reconfirmed, withdrawn, replaced by a revised edition, or amended. IMPORTANT The colour inside logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this document us

47、ing a colour printer. 60601-2-65 IEC:2012 5 INTRODUCTION This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for DENTAL INTRA-ORAL X-RAY EQUIPMENT. While the previously existing st

48、andards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of DENTAL INTRA-ORAL X-RAY EQUIPMENT. Components and their functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard ar

49、e considered to provide for a practical degree of safety in the operation of DENTAL INTRA-ORAL X-RAY EQUIPMENT. The minimum safety requirements for DENTAL EXTRA-ORAL X-RAY EQUIPMENT are specified in a separate particular standard IEC 60601-2-63 to simplify and improve the readability This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment Part 1: General req