IEC_TR_60930-2008.pdf

IEC/TR 60930Edition 2.0 2008-09TECHNICAL 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)LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 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 National Committee in the country of the requester.If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,please contact the address below or your local IEC member National Committee for further information.IEC Central Office 3,rue de Varemb CH-1211 Geneva 20 Switzerland 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 publications is kept under constant review by the IEC.Please make sure that you have the latest edition,a corrigenda or an amendment might have been published.?Catalogue of IEC publications:www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria(reference number,text,technical committee,).It also gives information on projects,withdrawn and replaced publications.?IEC Just Published:www.iec.ch/online_news/justpub Stay up to date on all new IEC publications.Just Published details twice a month all new publications released.Available on-line and also by email.?Electropedia:www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions in English and French,with equivalent terms in additional languages.Also known as the International Electrotechnical Vocabulary online.?Customer Service Centre:www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need further assistance,please visit the Customer Service Centre FAQ or contact us:Email:csciec.ch Tel.:+41 22 919 02 11 Fax:+41 22 919 03 00 LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.IEC/TR 60930Edition 2.0 2008-09TECHNICAL REPORT Guidelines for administrative,medical,and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems INTERNATIONAL ELECTROTECHNICAL COMMISSION UICS 11.040 PRICE CODEISBN 2-8318-1000-3 Registered trademark of the International Electrotechnical Commission LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.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 HAZARDS.8 5 BASIC SAFETY provisions of and symbols on ME EQUIPMENT.8 5.1 General.8 5.2 ACCOMPANYING DOCUMENTS.8 5.3 Colours of indicator lights.9 5.4 Markings on ME EQUIPMENT.9 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 marked.11 5.6 Protection against mechanical HAZARDS.11 5.6.1 Protection of PATIENTS,OPERATORS and others from suspended or moving masses.11 5.6.2 Stability.11 5.6.3 Protection against rough handling.11 6 Protection against thermal HAZARDS and fire prevention.12 6.1 APPLIED PARTS not intended to supply heat to the PATIENT.12 6.2 Protection against ignition in medical locations.12 7 Protection against unwanted or excessive radiation.12 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 DOCUMENTS.15 9.3 PATIENT ENVIRONMENT.15 9.4 MULTIPLE SOCKET-OUTLET(MSO).15 10 Protection against ingress of water or particulate matter.16 11 Cleaning,disinfection and sterilization.17 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 12.2.2 ACCOMPANYING DOCUMENTS.18 13 Electrical installations in medical locations.19 14 Purchasing and MAINTENANCE of equipment,training of personnel.19 14.1 Accountability.19 14.2 Purchasing.19 LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.TR 60930 IEC:2008(E)3 14.3 Delivery and commissioning.20 14.4 Training.20 14.5 MAINTENANCE.21 14.5.1 Concepts.21 14.5.2 MAINTENANCE programme.21 14.6 Checking of the installation and selection of the ME