IEC 60601-2-28-2017 Medical electrical equipment - Part 2-28 Particular requirements for the basic safety and essential performance of X-ray tube assemblies for.pdf

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1、 IEC 60601-2-28 Edition 3.0 2017-06 REDLINE VERSION Medical electrical equipment Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis IEC 60601-2-28:2017-06 RLV(en) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyr

2、ight 2017 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member Nati

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10、37, 77, 86 and CISPR. IEC Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csciec.ch. IEC 60601-2-28 Edition 3.0 2017-06 REDLINE VERSION Medical electrical equipment Part 2-2

11、8: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.55 ISBN 978-2-8322-4473-9 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you ob

12、tained this publication from an authorized distributor. colour inside 2 IEC 60601-2-28:2017 RLV IEC 2017 CONTENTS FOREWORD . 3 201.1 Scope, object and related standards . 6 201.2 Normative references 7 201.3 Terms and definitions 8 201.4 General requirements . 8 201.5 General requirements for testin

13、g ME EQUIPMENT 9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 10 201.7 ME EQUIPMENT identification, marking and documents . 10 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15 201.10 Protection a

14、gainst unwanted and excessive RADIATION HAZARDS 17 201.11 Protection against excessive temperatures and other HAZARDS . 17 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 18 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18 201.14 PROGRAMMA

15、BLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 19 201.15 Construction of ME EQUIPMENT . 19 201.16 ME SYSTEMS 19 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19 203 RADIATION protection in diagnostic X-RAY EQUIPMENT 20 Annexes . 21 Annex AA (informative) Test of X-RAY TUBE ASSEMBLIE

16、S for pressure-related RISKS expelled parts-related and/or tube implosion-related RISKS 21 Bibliography 22 Index of defined terms used in this particular standard 24 IEC 60601-2-28:2017 RLV IEC 2017 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-28: Particular requ

17、irements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis 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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28、version is not an official IEC Standard and is intended only to provide the user with an indication of what changes have been made to the previous version. Only the current version of the standard is to be considered the official document. This Redline version provides you with a quick and easy way

29、to compare all the changes between this standard and its previous edition. A vertical bar appears in the margin wherever a change has been made. Additions are in green text, deletions are in strikethrough red text. 4 IEC 60601-2-28:2017 RLV IEC 2017 International Standard IEC 60601-2-28 has been pre

30、pared by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 2010. This edition constitutes a technical revision. The third edition of this particular standard

31、 has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included. The text of

32、 this standard is based on the following documents: FDIS Report on voting 62B/1040/FDIS 62B/1051/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

33、 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 references: in smaller type. Normative text of tables is also i

34、n 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 numbered divisions within the table of contents, inclusive of all subdivisions (e

35、.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 by the clause number. References to subclauses within

36、 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 described in Clause 7 of the ISO/IEC Directives, Part 2. For

37、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 mandatory for compliance with this standard; “may” is us

38、ed 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 electrical equipment, can be found on the IEC website. IEC 60601-2-28:2017 RLV IEC 2017 5 The committee has decided that the conte

39、nts 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 reconfirmed, withdrawn, replaced by a revised edition, or amended. IMPORTANT The “

40、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 publication using a colour printer. 6 IEC 60601-2-28:2017 RLV IEC 2017 MEDICAL ELECTRICAL EQ

41、UIPMENT Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis 201.1 Scope, object and related standards Clause 1 of the general standard 1applies, except as follows: 201.1.1 Scope Replacement: This part of IEC 60601 applies t

42、o the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof, hereafter referred to as ME EQUIPMENT, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to ME EQUIPMENT, this is interpre

43、ted as X-RAY TUBE ASSEMBLIES in this particular standard. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME

44、 EQUIPMENT and to ME SYSTEMS, as relevant. NOTE This document is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE ASSEMBLIES and X- RAY TUBE HEADS. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE r

45、equirements for X-RAY TUBE ASSEMBLIES for medical diagnosis. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-3:2008 and IEC 60

46、601-1-3:2008/AMD1:2013 apply as modified in Clause 203. IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1- 11 and IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. NOTE 101 IEC 60601-1-2 does not

47、apply because RISKS for the X-RAY TUBE ASSEMBLY outside the system may only be indicative of RISKS for the system due to the difference in electromagnetic environment. NOTE 102 IEC 60601-1-6 and IEC 60601-1-8 do not apply because X-RAY TUBE ASSEMBLIES are not operated as a stand-alone device. _ 1The

48、 general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance. IEC 60601-2-28:2017 RLV IEC 2017 7 NOTE 103 X-RAY TUBE ASSEMBLIES are not in the scope of IEC 60601-1-10, IEC 60601-1-11 and IEC

49、 60601-1-12. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are re