IEC TR 62296-2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements《IEC 60601-1第2版中未提到的安全方面的考虑和对新要求的建议》.pdf

《IEC TR 62296-2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements《IEC 60601-1第2版中未提到的安全方面的考虑和对新要求的建议》.pdf》由会员分享，可在线阅读，更多相关《IEC TR 62296-2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements《IEC 60601-1第2版中未提到的安全方面的考虑和对新要求的建议》.pdf（82页珍藏版）》请在麦多课文档分享上搜索。

1、 IEC/TR 62296 Edition 2.0 2009-01 TECHNICAL REPORT Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements IEC/TR 62296:2009(E) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights reserved. Unless oth

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10、on 2.0 2009-01 TECHNICAL REPORT Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements INTERNATIONAL ELECTROTECHNICAL COMMISSION XC ICS 11.040 PRICE CODE ISBN 2-8318-1025-1 Registered trademark of the International Electrotechnical Commis

11、sion 2 TR 62296 IEC:2009(E) CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope and object7 1.1 Scope7 1.2 Object .7 2 Recommendations7 2.1 Summary of all recommendations prepared by SC 62A/WG 147 2.2 Recommendation sheets .10 2.2.1 Separation: Reliability of component impedance10 2.2.2 Separation: Non-compl

12、ying creepage distance and air clearances.12 2.2.3 Mains supply transformers: Overload test13 2.2.4 Mains supply transformers: Short circuit and overload tests.14 2.2.5 Creepage distance and air clearances: Values 15 2.2.6 Dielectric strength .16 2.2.7 Failure of components: Evidence of reliability1

13、7 2.2.8 ENCLOSURES and protective covers18 2.2.9 INTERNALLY POWERED EQUIPMENT: 110 % of the maximum supply voltage 19 2.2.10 Creepage distances and air clearances: Values under 1 mm .20 2.2.11 Separation: Secondary circuit impedance limit LEAKAGE CURRENT.21 2.2.12 ENCLOSURES and PROTECTIVE COVERS: L

14、ampholder/switching device22 2.2.13 Fixing, prevention of maladjustment: Torque test.23 2.2.14 Batteries not intended to be changed by OPERATOR: Lithium batteries24 2.2.15 Excessive temperatures: Ambient temperatures 25 2.2.16 Continuous LEAKAGE CURRENTS: Different SUPPLY MAINS .26 2.2.17 ENCLOSURE

15、and protective covers: EQUIPMENT in ambulances27 2.2.18 Dielectric strength: Voltages appearing from external sources.28 2.2.19 Testing switch mode power supply units (SMPSU).29 2.2.20 Failure of an electrical component: Time periodicity for detection 30 2.2.21 Environmental conditions: Compliance p

16、aragraph31 2.2.22 Limitation of voltage and/or energy: Capacitance.32 2.2.23 LEAKAGE CURRENTS: Presence of 45 k resistor in Figure 21 .33 2.2.24 Humidity preconditioning treatment: Exception from requirement.34 2.2.25 Dielectric strength: EQUIPMENT containing floating circuits .35 2.2.26 General req

17、uirements for tests: Measurement uncertainty .36 2.2.27 CREEPAGE DISTANCES and AIR CLEARANCES: Interpolated values37 2.2.28 Overheating: Change of load resistance 38 2.2.29 Mains operated EQUIPMENT with additional power source: Integrity of external protective earth39 2.2.30 Rechargeable batteries:

18、No OPERATOR/USER maintenance .40 2.2.31 Isolation from the SUPPLY MAINS: Symbol for single pole switch 41 2.2.32 Sequence of testing: Clause 52 before Clause 1942 2.2.33 SINGLE FAULT CONDITION: ENCLOSURE LEAKAGE CURRENT from INTERNALLY POWERED EQUIPMENT 43 2.2.34 Marking on the outside of EQUIPMENT:

19、 Type and rating of fuses .44 2.2.35 Excessive temperatures: APPLIED PARTS not intended to supply heat .45 2.2.36 Mains supply transformers: Use of PTCs as protective devices .46 TR 62296 IEC:2009(E) 3 2.2.37 Components and general assembly: Reliability of components 47 2.2.38 Definition of APPLIED

20、PART: EQUIPMENT worn by PATIENTS .48 2.2.39 Construction: Triple insulated winding wire49 2.2.40 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test versus CREEPAGE DISTANCES and AIR CLEARANCES 50 2.2.41 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test versus CREEPAGE DIST

21、ANCES and AIR CLEARANCES POWER SUPPLY CORDS51 2.2.42 ACCOMPANYING DOCUMENTS: on CD-ROM or electronic file format 52 2.2.43 INTERNAL ELECTRICAL POWER SOURCE: Requirements for lithium batteries 53 2.2.44 Dielectric strength: Differences between B-d and B-e 54 2.2.45 Excessive temperatures: Thermocoupl

22、e instead of resistance method.55 2.2.46 Mains fuses and OVER-CURRENT RELEASEs: Fuses in CLASS II EQUIPMENT .56 2.2.47 Plug in power supply .57 2.2.48 Connecting cords between EQUIPMENT parts: Other applications 58 2.2.49 MULTIPLE PORTABLE SOCKET-OUTLET59 2.2.50 Separation, DEFIBRILLATION-PROOF APPL

23、IED PART: multiple APPLIED PARTS 60 2.2.51 Separation, APPLIED PART: Hand held flexible shafts.61 2.2.52 Protective earthing: No-load voltage of 6 V maximum 62 2.2.53 Foot-operated control devices: Protection against entry of liquids63 2.2.54 Mains supply transformers.64 2.2.55 Dielectric strength:

24、Reliability of components to bridge A-a 2and B-a.65 2.2.56 Dielectric strength: A-e in switch mode power supply units (SMPSU).66 2.2.57 Dielectric strength: Connection of 12 V dc negative side to ENCLOSURE 67 2.2.58 Dielectric strength: Voltages appearing on SIP/SOP 68 2.2.59 APPLIED PART: EQUIPMENT

25、 without APPLIED PART .69 2.2.60 Scope: Other than MEDICAL ELECTRICAL EQUIPMENT in contact with the body of a person70 2.2.61 Markings: AC symbol.71 2.2.62 Interruption of power supply: Characteristics of interruption.72 2.2.63 Reference voltage: Different reference voltages in the same circuit .73

26、Bibliography74 Index of Terms76 4 TR 62296 IEC:2009(E) INTERNATIONAL ELECTROTECHNICAL COMMISSION _ CONSIDERATIONS OF UNADDRESSED SAFETY ASPECTS IN THE SECOND EDITION OF IEC 60601-1 AND PROPOSALS FOR NEW REQUIREMENTS FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organ

27、ization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of 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,

28、IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt w

29、ith may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by

30、 agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3)

31、 IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are

32、 used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and th

33、e corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they hav

34、e the latest edition of this publication. 7) No liability shall 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 whatso

35、ever, whether direct or indirect, or for costs (including legal 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 publicat

36、ions 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. The main task of IEC

37、 technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC 62296,

38、which is a technical report, has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition published in 2003. It constitutes a

39、 technical revision. This edition includes seven new recommendations: Recommendations 57 through 63. As the third edition of IEC 60601-1 has been published, some of the recommendations in this edition have been changed to align with requirements in IEC 60601-1:2005. TR 62296 IEC:2009(E) 5 The text o

40、f this technical report is based on the following documents: Enquiry draft Report on voting 62A/621/DTR 62A/632/RVC Full information on the voting for the approval of this technical report can be found in the report on voting indicated in the above table. This publication has been drafted in accorda

41、nce with the ISO/IEC Directives, Part 2. The committee has decided that the contents of this publication will remain unchanged until the maintenance result dateindicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication w

42、ill be reconfirmed; withdrawn; replaced by a revised edition, or amended. A bilingual version of this technical report may be issued at a later date. 6 TR 62296 IEC:2009(E) INTRODUCTION At the Sydney meeting in August 1994, IEC subcommittee (SC) 62A established a procedure under which working group

43、(WG) 14 would develop recommendations regarding problems of interpretation or application of IEC 60601-1. WG 14 is made up of experts with particular expertise in testing according to the requirements of IEC 60601-1. Many of the experts on WG 14 are employed by test houses with a long history of app

44、lying IEC 60601-1 to MEDICAL ELECTRICAL EQUIPMENT. While the National Committee members of SC 62A nominate these experts, their recommendations were not to be formally adopted through any official voting procedure. To reinforce this process, the Subcommittee specifically directed that the following

45、note appear on every page of the resulting informational circular: IMPORTANT NOTE: Per the 62A decision at Sydney (see RM3755/SC62A, August 1994), the 62A Secretary is circulating this recommendation, prepared by 62A/WG14, regarding problems of interpretation or application of IEC 60601-1 to all P-M

46、ember NCs. This recommendation/interpretation is the result of considerations by a group of nominated experts and has not been formally adopted through any NC voting procedure. Distribution is only for information. The plan approved in Sydney called for the 62A Secretary to circulate these recommend

47、ations to the member National Committees via an informational (INF) document. While the quality of the technical work of WG 14 is widely recognized and applauded, the overall process has achieved less than originally hoped. The INF documents have not proved a particularly successful way of getting t

48、his information to those who could use it most. The WG 14 recommendations are largely unknown beyond the people actively involved in the work of SC 62A. Several alternatives have been explored. These include making the individual recommendation sheets available on the Internet either through the IEC

49、 Web Site, the web site of a participating National Committee, or the web site of an interested third party. However, concerns over intellectual property and control of distribution have proved extremely difficult to overcome. At the November 2000 meeting of SC 62A in Tokyo, the subcommittee discussed ways and means for achieving a wider distribution of the WG 14 recommendations. At the conclusion of this discussion, the subcommittee instructed the Secretariat to develop a technical report (TR) ba