IEC 60601-2-17-2013 Medical electrical equipment - Part 2-17 Particular requirements for the basic safety and essential performance of automatically- controlled.pdf

1、 IEC 60601-2-17 Edition 3.0 2013-11 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment Appareils lectromdicaux Partie 2-17: Exigenc

2、es particulires pour la scurit de base et les performances essentielles des appareils projecteurs de sources radioactives chargement diffr automatique utiliss en brachythrapie IEC60601-2-17:2013 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2013 IEC, Geneva, Switzerland All rights reserved. Unle

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16、tore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-2-17 Edition 3.0 2013-11 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-17: Particular requirements for the basic safe

17、ty and essential performance of automatically-controlled brachytherapy afterloading equipment Appareils lectromdicaux Partie 2-17: Exigences particulires pour la scurit de base et les performances essentielles des appareils projecteurs de sources radioactives chargement diffr automatique utiliss en

18、brachythrapie INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE X ICS 11.040.60; 19.100 PRICE CODE CODE PRIX ISBN 978-2-8322-1214-1 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale W

19、arning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 60601-2-17 IEC:2013 CONTENTS FOREWORD . 3 INTRODUCTION . 6 Scope, object and related standards . 7 201.1Normative re

20、ferences 9 201.2Terms and definitions 10 201.3General requirements 12 201.4General requirements for testing ME EQUIPMENT . 12 201.5Classification of ME EQUIPMENT and ME SYSTEMS 12 201.6ME EQUIPMENT identification, marking and documents 13 201.7Protection against electrical HAZARDS from ME EQUIPMENT

21、17 201.8Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 18 201.9Protection against unwanted and excessive radiation HAZARDS 18 201.10Protection against excessive temperatures and other HAZARDS 37 201.11Accuracy of controls and instruments and protection against hazardous outputs

22、 . 37 201.12HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 40 201.13PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 40 201.14Construction of ME EQUIPMENT . 40 201.15ME SYSTEMS . 40 201.16Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 40 201.17Annex A (informative) Genera

23、l guidance and rationale . 41 Bibliography 42 Index of defined terms used in this particular standard 43 Table 201.101 Colours of lights and their meanings . 14 60601-2-17 IEC:2013 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-17: Particular requirements for the b

24、asic safety and essential performance of automatically-controlled brachytherapy afterloading equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The ob

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34、is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of 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 IE

35、C 60601-2-17 has been prepared by IEC subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition, published in 2004. Consideration has been

36、 given to new IEC standards, amendments to existing IEC standards, developments in technology and clinical usage, and various hazards encountered and envisaged since the preparation of the first and second editions. This edition constitutes a technical revision which brings this standard in line wit

37、h IEC 60601-1:2005+A1:2012 and its collateral standards. 4 60601-2-17 IEC:2013 The text of this particular standard is based on the following documents: FDIS Report on voting 62C/575/FDIS 62C/579/RVD Full information on the voting for the approval of this particular standard can be found in the repo

38、rt 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: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of

39、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, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one

40、 of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 201.7 includes subclauses 201.7.1, 201.7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all subclauses of Clause 201.7). References t

41、o clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this collateral standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions

42、 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 that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means t

43、hat 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 requirement or test. A list of all parts of the IEC 60601 series, published under the general title MEDICAL ELEC

44、TRICAL EQUIPMENT, can be found on the IEC website. 60601-2-17 IEC:2013 5 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

45、 date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 6 60601-2-17 IEC:2013 INTRODUCTION The delivery of RADIOTHERAPY over short distances is called BRACHYTHERAPY. BRACHYTHERAPY is delivered by positioning RADIATION SOURCES within or adjacent to the tissue

46、 to be treated. Historically, RADIOACTIVE SOURCES were handled manually, resulting in IRRADIATION of the OPERATORS hands. AFTERLOADING generally refers to the technique of placing an applicator into or adjacent to the tissue to be treated, and introducing one or more RADIATION SOURCE(S) only after t

47、he applicator position has been confirmed. This procedure minimizes the time during which the operator is exposed to the RADIATION SOURCE(S). Manual AFTERLOADING techniques were developed in the 1950s and are used routinely today for permanent implants, but less frequently for temporary implants. Te

48、mporary implants require the use of higher dose rates, to ensure that the treatment can be completed in a length of time easily tolerated by the PATIENT. In the 1980s, automatic remote AFTERLOADING techniques were developed, that could move a RADIOACTIVE SOURCE or SOURCES through connecting tubes fr

49、om a shielded safe to the applicators implanted in the patient. Because the SOURCE(S) could be moved remotely, the risk of exposure to personnel could be eliminated. In 2007 an automatic remote afterloader was introduced that replaced the conventional RADIOACTIVE SOURCE(S) with an X-ray source. This device otherwise performed similarly to AFTERLOADERS containing RADIOACTIVE SOURCES. However, the X-ray source could be d