SANS 60601-2-2-2009 Medical electrical equipment Part 2-2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequ.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. iISBN 978-0-626-22445-5 SANS 60601-2-2:2009Edition 1 IEC 60601-2-2:2009Edition 5SOUTH AFRICAN NATIONAL STANDARD Medical electrical equipment Part 2-2: Pa

4、rticular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories This national standard is the identical implementation of IEC 60601-2-2:2009 and is adopted with the permission of the International Electrotechnical Comm

5、ission. WARNING Can only be used in conjunction with SANS 60601-1. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 60601-2-2:2009 Edition 1 IEC 60601-2-2:2009 Edition 5 Table of changes

6、 Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 72, Safety of electrical appliances and electronic equipment, in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS d

7、ocument was published in May 2009. IEC 60601-2-2Edition 5.0 2009-02INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories App

8、areils lectromdicaux Partie 2-2: Exigences particulires pour la scurit de base et les performances essentielles des appareils dlectrochirurgie courant haute frquence et des accessoires dlectrochirurgie courant haute frquence INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTER

9、NATIONALE XCICS 11.040.30 PRICE CODECODE PRIXISBN 2-8318-1029-9 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale SANS 60601-2-2:2009This s tandard may only be used and printed by approved subscription and freemailing

10、clients of the SABS . 2 60601-2-2 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.7 201.1 Scope, object and related standards .8 201.2 Normative references 9 201.3 Terms and definitions10 201.4 General requirements13 201.5 General requirements for testing of ME EQUIPMENT.14 201.6 Classification of ME EQUI

11、PMENT and ME SYSTEMS 14 201.7 ME EQUIPMENT identification, marking and documents14 201.8 Protection against electrical HAZARDS from ME EQUIPMENT19 201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS.33 201.10 Protection against unwanted and excessive radiation HAZARDS33 201.11

12、 Protection against excessive temperatures and other HAZARDS34 201.12 Accuracy of controls and instruments and protection against hazardous outputs35 201.13 HAZARDOUS SITUATIONS and fault conditions.41 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .42 201.15 Construction of ME EQUIPMENT .42

13、201.16 ME SYSTEMs 46 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .46 202 * Electromagnetic compatibility Requirements and tests .46 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems47 Annexes .47 Anne

14、x AA (informative) Particular guidance and rationale48 Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL EQUIPMENT 70 Bibliography79 Figure 201.101 Symbol used with an EARTH REFERENCED PATIENT CIRCUIT.14 Figure 201.102 Symbol used with a HF ISOLATED PATIENT CIRCUIT .15 Figur

15、e 201.103 Circuit suitable for testing compliance to 201.8.4.101 20 Figure 201.104 Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE referenced to earth and load between electrodes23 Figure 201.105 Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE referenced to earth and load from ACTI

16、VE ELECTRODE to earth .24 Figure 201.106 Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE isolated from earth at HIGH FREQUENCY25 Figure 201.107 Measurement of HF LEAKAGE CURRENT from a BIPOLAR ELECTRODE 26 Figure 201.108 Test apparatus for anchorages of cords of ACTIVE ACCESSORY.32 Figure 2

17、01.109 Measurement of output power MONOPOLAR output .37 Figure 201.110 Measurement of output power BIPOLAR output.38 SANS 60601-2-2:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .60601-2-2 IEC:2009 3 Figure 201.111 Method of testing feed

18、back from one active output to another in simultaneous activation.41 Figure AA.1 Example of various parts of an HF surgical system49 Figure AA.2 CREST FACTOR vs. peak voltage 53 Figure AA.3 Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth at operating frequencies .57 Figure BB.1

19、 E-FIELD EMISSIONS test setup.73 Figure BB.2 H-FIELD EMISSIONS test setup 74 Figure BB.3 Conducted EMISSIONS test setup .75 Figure BB.4 Unit ad hoc test 77 Figure BB.5 Power cord ad hoc test.78 Figure BB.6 ACCESSORY cord ad hoc test .78 Table 201.101 Colours of indicator lights and their meaning for

20、 HF SURGICAL EQUIPMENT 15 Table 201.102 Maximum output powers in SINGLE FAULT CONDITIONS 40 Table 201.103 Test currents by weight range.44 Table AA.1 Summary of measured current and durations for 25 TUR procedures.65 Table AA.2 Summary of measured currents and durations for general surgical procedur

21、es .66 Table BB.1 Worst case emissions of spark gap type HF SURGICAL EQUIPMENT .76 Table BB.2 Worst case emissions of non-spark gap (modern) HF SURGICAL EQUIPMENT .76 SANS 60601-2-2:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS . 4 60601

22、-2-2 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories FOREWORD 1) The International Electrotechnical Commissi

23、on (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 all questions concerning standardization in the electrical and electronic fields. To this end and in a

24、ddition to other activities, 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 inte

25、rested 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. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance w

26、ith conditions determined by 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

27、 IEC National Committees. 3) 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 f

28、or the way in which they are 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 betwee

29、n any IEC Publication and the 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

30、 should ensure that they have 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

31、 damage of any nature whatsoever, 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. Us

32、e of the referenced publications 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

33、rights. International standard IEC 60601-2-2 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This fifth edition cancels and replaces the fourth edition published in 2006. This edition constitutes a technica

34、l revision. Revisions in this edition include new language for preconditioning accessories prior to insulation testing, refining the requirements for electromagnetic compatibility testing and correcting some of the equations used in deriving the thermal test for NEUTRAL ELECTRODES. SANS 60601-2-2:20

35、09This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .60601-2-2 IEC:2009 5 The text of this particular standard is based on the following documents: FDIS Report on voting 62D/726/FDIS 62D/755/RVD Full information on the voting for the approval of

36、 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 ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: itali

37、c type. Informative material appearing outside of 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 struc

38、ture of this standard, the term “clause” means one of the seventeen numbered divisions within the 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 C

39、lause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this 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

40、 conditions 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; “shou

41、ld” means that 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. An asterisk (*) as the first character of a title or at the beginning of a parag

42、raph or table title indicates that there is guidance or rationale related to that item 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. SANS 60601-2-2:2009This s tandard may only be used and pri

43、nted by approved subscription and freemailing clients of the SABS . 6 60601-2-2 IEC:2009 The committee has decided that the contents of this particular standard will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to

44、the specific publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended SANS 60601-2-2:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .60601-2-2 IEC:2009 7 INTRODUCTION The minimum

45、 safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of high frequency surgical equipment. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment Part 1: General

46、 requirements for basic safety and essential performance, hereinafter referred to as the general standard (see 201.1.4). The requirements are followed by specifications for the relevant tests. A “Particular guidance and rationale“ section giving some explanatory notes, where appropriate, about the m

47、ore important requirements is included in annex AA. Clauses or subclauses for which there are explanatory notes in annex AA are marked with an asterisk (*). It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but wil

48、l, in due course, expedite any revision neces-sitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this standard. SANS 60601-2-2:2009This s tandard may only be used and printed by approved subscription and

49、 freemailing clients of the SABS . 8 60601-2-2 IEC:2009 MEDICAL ELECTRICAL EQUIPMENT Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories 201.1 Scope, object and related standards Clause 1 of the general standard1)applies, except as follows: 201.1.1 * Scope Replacement: This International Standard applies to the BASIC SAFE