IEC 60601-2-63-2012 Medical electrical equipment - Part 2-63 Particular requirements for the basic safety and essential performance of dental extra-oral X-ray e.pdf

1、 IEC 60601-2-63 Edition 1.0 2012-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment Appareils lectromdicaux Partie 2-63: Exigences particulires pour la scur

2、it de base et les performances essentielles des appareils rayonnement X dentaires extra-oraux IEC60601-2-63:2012 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 60601-2-63Edition 1.0 2012-09INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment Apparei

17、ls lectromdicaux Partie 2-63: Exigences particulires pour la scurit de base et les performances essentielles des appareils rayonnement X dentaires extra-oraux INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XICS 11.040.50 PRICE CODECODE PRIXISBN 978-2-83220-382-8

18、 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un di

19、stributeur agr. colourinside 2 60601-2-63 IEC:2012 CONTENTS FOREWORD . 4 INTRODUCTION . 7 201.1 Scope, object and related standards . 8 201.2 Normative references 10 201.3 Terms and definitions 11 201.4 General requirements 12 201.5 General requirements for testing of ME EQUIPMENT . 13 201.6 Classif

20、ication of ME EQUIPMENT and ME SYSTEMS 13 201.7 ME EQUIPMENT identification, marking and documents 13 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 16 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 17 201.10 Protection against unwanted and excessive radiat

21、ion HAZARDS 18 201.11 Protection against excessive temperatures and other HAZARDS 18 201.12 Accuracy of controls and instruments and protection against hazardous outputs 18 201.13 HAZARDOUS SITUATIONS and fault conditions . 18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18 201.15 Constru

22、ction of ME EQUIPMENT . 18 201.16 ME SYSTEMS 18 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19 202 Electromagnetic compatibility Requirements and tests . 19 203 Radiation protection in diagnostic X-ray equipment . 19 Annexes . 31 Annex C (informative) Guide to marking and l

23、abelling requirements for ME EQUIPMENT and ME SYSTEMS 32 Annex AA (informative) Particular guidance and rationale 33 Bibliography 39 Index of defined terms used in this particular standard 42 Figure 203.101 Zone of EXTRA-FOCAL RADIATION . 28 Figure AA.1 PANORAMIC X-RAY EQUIPMENT . 33 Figure AA.2 AIR

24、 KERMA during IRRADIATION with direct current X-RAY GENERATOR . 35 Figure AA.3 AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR . 36 Figure AA.4 Example series of (numerous) pulsed IRRADIATIONS for a CBCT (cone beam computed tomography) IRRADIATION event, with CONSTANT POTENTIAL HIGH-VOLTA

25、GE GENERATOR and time-width modulation 37 Figure AA.5 Example series of two irradiations for PANORAMIC-like views of right and left TMJ (temporo-mandibolar joint) in the same image, with ONE-PEAK HIGH-VOLTAGE GENERATOR 37 60601-2-63 IEC:2012 3 Table 201.101 List of potential ESSENTIAL PERFORMANCE to

26、 be considered by MANUFACTURER in the RISK MANAGEMENT PROCESS 13 Table 201.C.101 Marking on the outside of ME EQUIPMENT or its parts 32 Table 201.C.102 Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 32 4 60601-2-63 IEC:2012 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL

27、EQUIPMENT Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC Na

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38、 International Standard IEC 60601-2-63 has been prepared by IEC subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. The text of this particular standard is based on the following documents: FDIS Report on voting 62B/888/FDIS 62B/89

39、8/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 table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: 60601-2-63 I

40、EC:2012 5 Requirements and definitions: in roman type. Test specifications: in italic type. Informative material appearing outside of tables, such as notes, 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

41、 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 numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means

42、 a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the

43、 conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means tha

44、t compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requir

45、ement 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 rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipme

46、nt, can be found on the IEC website. 6 60601-2-63 IEC:2012 The committee has decided that the contents of this publication will remain unchange-d 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 pu

47、blication will be 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

48、 this document using a colour printer. 60601-2-63 IEC:2012 7 INTRODUCTION This particular standard has been prepared to provide, based on IEC 60601-1:2005 (third edition), and its collaterals, a complete set of BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for DENTAL EXTRA-ORAL X-RAY EQUIPMENT

49、 While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. Components and their functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operat