CAN CSA-C22 2 NO 60601-2-7-2001 Medical electrical equipment - Part 2-7 Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators (Second Edi.pdf

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1、: . CANADIAN STANDARDS National Standard of Canada CANKSA-C22.2 No. 60601-2-7-01 ASSOCIATION (IEC 60601-2-7:1!398) /- International Standard IEC 60601-Z-7: 1998 (second edition, 1998-02) has been adopted without modification as CSA Standard CAN/CSA-C22.2 No. 60601-2-7-01, which has been approved as

2、a National Standard of Canada by the Standards Council of Canada. ISBN l-55324-457-5 lune 2001 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators Appareils klectrom6dicaux - Partie 2-7: Regles particuli this remai

3、ns the continuing responsibility of the accredited standards-development organization. Those who have a need to apply standards are encouraged to use National Standards of Canada whenever practicable. These standards are subject to periodic review; therefore, users are cautioned to obtain the latest

4、 edition from the organization preparing the standard. The responsibility for approving National Standards of Canada rests with the Standards Council of Canada 270 Albert Street, Suite 200 Ottawa, Ontario, Kl P 6N7 Canada Although the intended primary application of this Standard is stated in its Sc

5、ope, it is important to note that it remains the responsibility of the users to judge its suitability for their particular purpose. Registered trade-mark of Canadian Standards Association CAN/CSA-C22.2 No. 6060 l-2-7-01 Medical electrical equipment - Part 2-7: Particular requirements for the safety

6、of high-voltage generators of diagnostic X-ray generators CAN/CSA-C22.2 No. 60601-Z-7-01 Medical eZectricuZ equipment - Part 2-7: Particular requirements for the safkty of high-voltage generators of diapostic X-ray generators CSA Preface This is the second edition of CSA Standard CAN/CSA-C22.2 No. 6

7、0601-2-7, Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-7 (second edition,

8、 1998-02), currently available from IEC in English only. It supersedes the previous edition published in 1992 as CANKSAC22.2 No. 601.2.7 (adopted IEC 601-2-7:1987). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. This Standard is intended to be used in

9、 conjunction with CSA Standard CANKSA-C22.2 No. 601 .l -M90, Medical electrical equipment - Part 7: General requirements for safety, which is an adoption, with Canadian deviations, of the identically titled CEVIEC Standard 601-l (second edition, 1988), including Amendments 1 :1991 and 2:1995. This S

10、tandard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products under the jurisdiction of the Strategic Resource Group, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the Te

11、chnical Committee on Applications of Electricity in Health Care under the jurisdiction of the Strategic Steering Committee on Health Care Technology. Lists of the members of these Technical Committees are available upon request. This Standard has been approved as a National Standard of Canada by the

12、 Standards Council of Canada. Interpretations: The Strategic Resource Group has provided the following direction for the interpretations of standards under its jurisdiction: “The literal text shall be used in judging compliance of products with the safety requirements of this Standard. When the lite

13、ral text cannot be applied to the product, such as for new materials or construction, and when a relevant committee interpretation has not already been published, CSAs procedures for Interpretation shall be followed to determine the intended safety principle.” June 200 7 0 Canadian Standards Associa

14、tion - 200 1 All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. /EC material is reprinted with permission. Where the words “this International Standard“ appear in the text, they should be interpreted as “this Natio

15、nal Standard of Canada”. Inquiries regarding this National Standard of Canada should be addressed to Canadian Standards Association 178 Rexdale Boulevard, Toronto, Ontario, Canada M9W 1 R3 l-800-463-6727.416-747-4044 www.csa.ca CSA/2 0 Canadian Standards Association lune 200 7 CAN/CSA-C22.2 No. 6060

16、1-2-7-07 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators CSA Foreword The Canadian Standards Association (CSA) develops standards under the name Canadian Standards Association, and provides certification and te

17、sting under the name CSA International. CSA International provides certification services for manufacturers who, under license from CSA, wish to use the appropriate registered CSA Marks on certain products of their manufacture to indicate conformity with CSA Standards. CSA Certification for a number

18、 of products is provided in the interest of maintaining agreed-upon standards of quality, performance, interchangeability and/or safety, as appropriate. Where applicable, certification may form the basis for acceptance by inspection authorities responsible for enforcement of regulations. Where feasi

19、ble, programs will be developed for additional products for which certification is desired by producers, consumers, or other interests. In performing its functions in accordance with its objectives, CSA does not assume or undertake to discharge any responsibility of the manufacturer or any other par

20、ty. The opinions and findings of the Association represent its professional judgement given with due consideration to the necessary limitations of practical operation and state of the art at the time the Standard is processed. Products in substantial accord with this Standard but which exhibit a min

21、or difference or a new feature may be deemed to meet the Standard providing the feature or difference is found acceptable utilizing appropriate CSA International Operating Procedures. Products that comply with this Standard shall not be certified if they are found to have additional features which a

22、re inconsistent with the intent of this Standard. Products shall not be certifiable if they are discovered to contravene applicable laws or regulations. Testing techniques, test procedures, and instrumentation frequently must be prescribed by CSA International in addition to the technical requiremen

23、ts contained in Standards of CSA. In addition to markings specified in the Standard, CSA International may require special cautions, markings, and instructions that are not specified by the Standard. Some tests required by CSA Standards may be inherently hazardous. The Association neither assumes no

24、r accepts any responsibility for any injury or damage that may occur during or as the result of tests, wherever performed, whether performed in whole or in part by the manufacturer or the Association, and whether or not any equipment, facility, or personnel for or in connection with the test is furn

25、ished by the manufacturer or the Association. Manufacturers should note that, in the event of the failure of CSA International to resolve an issue arising from the interpretation of requirements, there is an appeal procedure: the complainant should submit the matter, in writing, to the Secretary of

26、the Canadian Standards Association. If this Standard is to be used in obtaining CSA Certification please remember, when making application for certification, to request all current Amendments, Bulletins, Notices, and Technical Information Letters that may be applicable and for which there may be a n

27、ominal charge. For such information or for further information concerning CSA Certification, please address your inquiry to Applications and Customer Service, CSA International, 178 Rexdale Boulevard, Toronto, Ontario, Canada M9W 1 R3. June 200 1 0 Canadian Standards Association CSA/3 INTERNATIONAL

28、IEC STANDARD 60601-2-7 Second edition 1998-02 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators Appareils . 17 SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED

29、OR EXCESSIVE RADIATION 29 X-RADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 29.1 X-RADIATION generated by dia

30、gnostic X-RAY GENERATORS containing HIGH-VOLTAGE GENERATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 36 Electromagnetic compatibility .* 22 - 60601-2-7 0 IEC:1998 (E) -3- SECTI

31、ON 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS 42 Excessive temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data . 23 50.1 General 23 50.101 Indication of electric and RADIATION output 23 50.102 Reproducibility, linearity and con

33、stancy 24 50.103 Accuracy of LOADING FACTORS . 28 50.104 Test conditions 28 50.105 Conditions for measuring AIR KERMA . 30 51 Protection against hazardous output 32 SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION 10: CONSTRUCTIONAL REQUIREMENTS 56 Components and gener

34、al assembly 32 56.7 Batteries 32 57 MAINS PARTS, components and layout . 33 57.10 CREEPAGE DISTANCES and AIR CLEARANCES 33 Tables 101 Reference values for the APPARENT RESISTANCE OF SUPPLY MAINS 13 102 Duration of dielectric strength test 17 103 LOADINGS for testing AUTOMATIC EXPOSURE CONTROLS 27 10

35、4 ATTENUATION for the measurement of AIR KERMA . 31 105 Tests for verifying reproducibility and linearity . 32 CC.1 Recommended LOADING FACTORS for the testing of accuracy . 41 CC.2 Test settings for measurement of AIR KERMA . 42 Figures 101 Recommended arrangement for measuring AIR KERMA . . . . .

36、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 102 Recommended arrangement for film density testing AUTOMATIC CONTROL SYSTEMS provided with a TRANSMISSION CHAMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Annexes AA Terminology - Index of defined terms . 36 BB Values of the series RlO and R20, IS0 497 . 39 CC Choosing LOADING FACTORS for tests . 40 -4- 80601 -2-7 Q IEC:1998 (E) INTERNATIONAL ELECTROTECHNICAL COMMISSION MEDICAL ELECTRICAL EQU

38、IPMENT - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators FOREWORD 1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Commit

39、tees). The object of the IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted to technical committee

40、s; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for

41、 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an international consensus of oprmon on the relevant subjects since each technical committ

42、ee has representation from all interested National Committees. 3) The documents produced have the form of recommendations for international use and are published in the form of standards, technical reports or guides and they are accepted by the National Committees in that sense. 4) In order to promo

43、te international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly ind

44、icated in the latter. 5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards. 6) Attention is drawn to the possibility that some of the elements of this International Standard may b

45、e the subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 60601-2-7 has been prepared by subcommittee 628: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This

46、 second edition cancels and replaces the first edition published in 1987, and constitutes a technical revision. The text of this standard is based on the following documents: I FDIS I Report on voting I I 62B1329IFDIS I 6281334lRVD I Full information on the voting for the approval of this standard c

47、an be found in the report on voting indicated in the above table. Annexes AA and BB form an integral part of this standard. Annex CC is for information only. In this standard, the following print types are used: - requirements, compliance with which can be tested and definitions: roman type; - expla

48、nations, advice, notes, general statements and exceptions: smaller type; - test specifications: italic type; - TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR IN IEC 60766: SMALL CAPITALS. A bilingual version of this standard may be issued at a later date. . - 60601-2-7 0 IEC:1998 (E) -5- MEDIC

49、AL ELECTRICAL EQUIPMENT - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators SECTION 1: GENERAL The clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Replacement: This Particular Standard applies to HIGH-VOLTAGE GENERATORS of medical diagnostic X-RAY GENERATORS and to their subassemblies including the following: - HIGH-VOLTAGE GENERATORS that are integrated with an X-RAY TUBE ASSEMBLY; - HIGH-VOLTAGE GE