IEC 60601-2-36-2014 Medical electrical equipment - Part 2-36 Particular requirements for the basic safety and essential performance of equipment for extracorpor.pdf

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1、 IEC 60601-2-36 Edition 2.0 2014-04 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy Appareils lectromdicaux Partie 2-36: Exigences particul

2、ires pour la scurit de base et les performances essentielles des appareils pour lithotritie cre de faon extracorporelle IEC 60601-2-36:2014-04(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publi

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20、014-04 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy Appareils lectromdicaux Partie 2-36: Exigences particulires pour la scurit de base e

21、t les performances essentielles des appareils pour lithotritie cre de faon extracorporelle INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE S ICS 11.040.01 PRICE CODE CODE PRIX ISBN 978-2-8322-1498-5 Registered trademark of the International Electrotechnical Commi

22、ssion 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 distributeur agr. 2 IEC 60601-2-36:2014 IEC 2014 CONTENTS FOREWORD

23、. 3 INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references 8 201.3 Terms and definitions 9 201.4 General requirements 10 201.5 General requirements for testing ME EQUIPMENT . 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identificatio

24、n, marking and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12 201.9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME SYSTEMS . 12 201.10 Protection against unwanted and excessive radiation HAZARDS 13 201.11 Protection against excessive temperatures and othe

25、r HAZARDS 13 201.12 Accuracy of controls and instruments and protection against hazardous outputs 13 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 14 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15 201.15 Construction of ME EQUIPMENT . 15 201.16 ME SYSTEMS . 15 201.1

26、7 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 15 202 * ELECTROMAGNETIC COMPATIBILITY Requirements and tests 15 Annexes . 15 Annex AA (informative) Particular guidance and rationale 16 Annex BB (informative) Definition of coordinates, FOCUS and TARGET LOCATION 17 Bibliography 18 In

27、dex of defined terms used in this particular standard 20 Figure BB.1 Geometrical FOCUS distribution . 17 IEC 60601-2-36:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-36: Particular requirements for the basic safety and essential performance of equipm

28、ent for extracorporeally induced lithotripsy FOREWORD 1) The International 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 al

29、l questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publi

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36、l attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including lega

37、l fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publ

38、ication. 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 IEC 60601-2-36 has been prepared by IEC subcommittee 62D: E

39、lectromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendmen

40、t 1:2012). 4 IEC 60601-2-36:2014 IEC 2014 The text of this particular standard is based on the following documents: FDIS Report on voting 62D/1109/FDIS 62D/1122/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

41、 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 tables, such as notes, examples and

42、 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 numbered divisions within t

43、he table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means 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

44、 by the clause number. References to subclauses within this particular 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 is true. The verbal forms used in this standard conform to usage describ

45、ed 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 that compliance with a requirement or a test is recommended but is not man

46、datory 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 rationale related to that it

47、em in Annex AA. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. IEC 60601-2-36:2014 IEC 2014 5 The committee has decided that the contents of this publication will remain unchanged until the stability date

48、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 reconfirmed, withdrawn, replaced by a revised edition, or amended. 6 IEC 60601-2-36:2014 IEC 2014 INTRODUCTION This particular standard concerns the BASI

49、C SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY. It amends and supplements IEC 60601-1/A1:2012 (Ed. 3.1): Medical electrical equipment Part 1: General requirements for basic safety and essential performance), hereinafter referred to as the general standard. The aim of this second edition is to bring this particular standard up to date with reference to the third edit