IEC TR 60930-2008 Guidelines for administrative medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical sys.pdf

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1、 IEC/TR 60930 Edition 2.0 2008-09 TECHNICAL REPORT Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems IEC/TR 60930:2008(E) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 IEC, Geneva, Switzerland

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4、d Email: inmailiec.ch Web: www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC

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9、 TECHNICAL REPORT Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems INTERNATIONAL ELECTROTECHNICAL COMMISSION U ICS 11.040 PRICE CODE ISBN 2-8318-1000-3 Registered trademark of the International Electr

10、otechnical Commission 2 TR 60930 IEC:2008(E) CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope.7 2 Normative references .7 3 Terms and definitions .8 4 Nature of HAZARDS8 5 BASIC SAFETY provisions of and symbols on ME EQUIPMENT8 5.1 General .8 5.2 ACCOMPANYING DOCUMENTS8 5.3 Colours of indicator lights9 5.

11、4 Markings on ME EQUIPMENT9 5.5 Protection against electric shock .9 5.5.1 Method of protection for ME EQUIPMENT 9 5.5.2 Degree of protection of APPLIED PARTS .10 5.5.3 ME EQUIPMENT not properly marked11 5.6 Protection against mechanical HAZARDS.11 5.6.1 Protection of PATIENTS, OPERATORS and others

12、from suspended or moving masses11 5.6.2 Stability .11 5.6.3 Protection against rough handling11 6 Protection against thermal HAZARDS and fire prevention12 6.1 APPLIED PARTS not intended to supply heat to the PATIENT12 6.2 Protection against ignition in medical locations12 7 Protection against unwant

13、ed or excessive radiation12 8 ALARM SYSTEMS.12 8.1 General .12 8.2 ALARM CONDITION priorities.13 8.3 Visual ALARM SIGNALS 14 8.4 Auditory ALARM SIGNALS .14 9 BASIC SAFETY provisions for ME SYSTEMS.14 9.1 General .14 9.2 ACCOMPANYING DOCUMENTS15 9.3 PATIENT ENVIRONMENT15 9.4 MULTIPLE SOCKET-OUTLET (M

14、SO)15 10 Protection against ingress of water or particulate matter.16 11 Cleaning, disinfection and sterilization17 12 Electromagnetic phenomena 17 12.1 General recommendations.17 12.2 Identification, marking and documents.18 12.2.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts 18 12.

15、2.2 ACCOMPANYING DOCUMENTS18 13 Electrical installations in medical locations .19 14 Purchasing and MAINTENANCE of equipment, training of personnel 19 14.1 Accountability19 14.2 Purchasing 19 TR 60930 IEC:2008(E) 3 14.3 Delivery and commissioning 20 14.4 Training.20 14.5 MAINTENANCE.21 14.5.1 Concep

16、ts.21 14.5.2 MAINTENANCE programme 21 14.6 Checking of the installation and selection of the ME EQUIPMENT or ME SYSTEM22 14.6.1 Installation.22 14.6.2 Verification of equipment safety.22 14.6.3 Single items of ME EQUIPMENT 22 14.6.4 Combinations of ME EQUIPMENT22 14.6.5 Connection of ME EQUIPMENT or

17、 an ME SYSTEM to the health care facilities data network .22 15 Recommended practice 23 Annex A (informative) PATIENT ENVIRONMENT25 Bibliography26 Index of defined terms used in this technical report.27 Figure 1 Symbols indicating the degree of protection provided by an APPLIED PART 10 Figure 2 Symb

18、ols indicating the degree of protection against the effects of a discharge of a cardiac defibrillator 10 Figure 3 Safety signs indicating a RISK from a person pushing, sitting or stepping on ME EQUIPMENT .11 Figure 4 Symbols indicating the ME EQUIPMENT is designed to avoid ignition of FLAMMABLE ANAE

19、STHETIC MIXTURE WITH AIR, or FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE .12 Figure 5 Example of the construction of a MULTIPLE SOCKET-OUTLET (MSO)16 Figure A.1 Example of PATIENT ENVIRONMENT25 Table 1 Colours of indicator lights and their meaning for ME EQUIPMENT .9 Table 2 ALARM CON

20、DITION priorities from IEC 60601-1-8:2006 14 Table 3 Characteristics of alarm indicator lights from IEC 60601-1-8:2006.14 4 TR 60930 IEC:2008(E) INTERNATIONAL ELECTROTECHNICAL COMMISSION _ GUIDELINES FOR ADMINISTRATIVE, MEDICAL, AND NURSING STAFF CONCERNED WITH THE SAFE USE OF MEDICAL ELECTRICAL EQU

21、IPMENT AND MEDICAL ELECTRICAL SYSTEMS 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 all quest

22、ions 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 Publication(

23、s)”). Their preparation is entrusted to technical committees; 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. IEC coll

24、aborates closely with the International Organization for Standardization (ISO) in accordance with 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

25、on the relevant subjects since each technical committee has representation from all interested 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 ensur

26、e that the technical content of IEC Publications is accurate, IEC cannot be held responsible for 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

27、the maximum extent possible in their national and regional publications. Any divergence between 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 re

28、sponsible for any equipment declared to be in conformity with an IEC Publication. 6) All users 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 tech

29、nical 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 legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

30、 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 publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subje

31、ct of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC 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 diff

32、erent kind from that which is normally published as an International Standard, for example “state of the art“. IEC 60930, 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 equ

33、ipment in medical practice. This second edition cancels and replaces the first edition published in 1988. This edition constitutes a technical revision. This edition has been aligned with IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-8:2006 and IEC 62353:2007. This edition includes medical elect

34、rical systems within its scope. TR 60930 IEC:2008(E) 5 The text of this technical report is based on the following documents: Enquiry draft Report on voting 62A/614/DTR 62A/626/RVC Full information on the voting for the approval of this technical report can be found in the report on voting indicated

35、 in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data re

36、lated to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. 6 TR 60930 IEC:2008(E) INTRODUCTION The amount of electrical equipment and the number of

37、medical procedures employing MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS continue to grow. In order to prevent accidents or near accidents such as burns, excessive radiation, electrical shock or even cardiac arrest, procedures should be available to handle the selection, installation,

38、 application and MAINTENANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS by qualified personnel. In order to establish a satisfactory level of BASIC SAFETY and performance for MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS and electrical installations in medical location

39、s, requirements for design and construction are specified in standards prepared by the IEC. These standards are intended to cover the design and construction of new equipment and installations (see the Bibliography). The requirements of these standards should also be met if the equipment or installa

40、tion is REPAIRED or modified. IEC 60513 explains the basic aspects of safety philosophy. The following guidelines are suggested: The MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM has to be safe, that is, built to the relevant IEC standards. The electrical installation in medical location

41、s has to be safe, that is, in accordance with the relevant IEC standards or corresponding national regulations. The instructions for use have to be available at the site of use. The instructions for use, warning statements and markings on MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM h

42、ave to be written in a language acceptable to the OPERATOR. Besides their knowledge of the medical procedure, the OPERATORS need to know the BASIC SAFETY characteristics and performance of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM. This can be achieved by instruction and training

43、 under the supervision of the RESPONSIBLE ORGANIZATION)e.g. by the MANUFACTURER or the CLINICAL ENGINEERING DEPARTMENT of the health care facility. NOTE 1 In IEC 60601-1:2005, the RESPONSIBLE ORGANIZATION is defined as the entity accountable for the use and maintenance of the ME EQUIPMENT or the ME

44、SYSTEM. The accountable entity can be, for example, a hospital, an individual clinician or a lay person. In home use applications, the PATIENT, OPERATOR and RESPONSIBLE ORGANIZATION can be one and the same person. In earlier editions of IEC 60601-1, the RESPONSIBLE ORGANIZATION was referred to as th

45、e “user.” The RESPONSIBLE ORGANIZATION and CLINICAL ENGINEERING DEPARTMENT have to ensure that BASIC SAFETY and performance, including the ESSENTIAL PERFORMANCE, of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM are maintained by an effective MAINTENANCE scheme. This can be achieved b

46、y an adequate MAINTENANCE programme and regular SERVICING performed by an appropriately staffed and organized CLINICAL ENGINEERING DEPARTMENT. NOTE 2 This report contains a simplified explanation which is partly related to IEC 60513:1994, Fundamental aspects of safety standards for medical electrica

47、l equipment, and partly to IEC 60601-1:2005: Medical electrical equipment, Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electrom

48、agnetic compatibility Requirements and tests and IEC 60601-1-8:2006, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical

49、electrical systems. Due to the nature of this report it is recommended that it be translated into the language spoken in each country. At the same time, National Committees are asked to go through the report thoroughly in order to amend the text to contain the special national requirements (e.g. depending on the electrical installations). This technical report applies to MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS and electrical installations in medical locations. The term “e