IEC_60601-2-30-1999.pdf

INTERNATIONALSTANDARDIEC60601-2-30Second edition1999-12Medical electrical equipment Part 2-30:Particular requirements for the safety,including essential performance,of automatic cycling non-invasiveblood pressure monitoring equipmentAppareils lectromdicaux Partie 2-30:Rgles particulires de scurit et performancesessentielles des appareils de surveillancede la pression sanguine prleve indirectement,automatiquement et priodiquementReference numberIEC 60601-2-30:1999(E)LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.NumberingAs from 1 January 1997 all IEC publications are issued with a designation in the60000 series.Consolidated publicationsConsolidated versions of some IEC publications including amendments areavailable.For example,edition numbers 1.0,1.1 and 1.2 refer,respectively,to thebase publication,the base publication incorporating amendment 1 and the basepublication incorporating amendments 1 and 2.Validity of this publicationThe technical content of IEC publications is kept under constant review by the IEC,thus ensuring that the content reflects current technology.Information relating to the date of the reconfirmation of the publication is availablein the IEC catalogue.Information on the subjects under consideration and work in progress undertakenby the technical committee which has prepared this publication,as well as the listof publications issued,is to be found at the following IEC sources:IEC web site*Catalogue of IEC publicationsPublished yearly with regular updates(On-line catalogue)*IEC BulletinAvailable both at the IEC web site*and as a printed periodicalTerminology,graphical and letter symbolsFor general terminology,readers are referred to IEC 60050:InternationalElectrotechnical Vocabulary(IEV).For graphical symbols,and letter symbols and signs approved by the IEC forgeneral use,readers are referred to publications IEC 60027:Letter symbols to beused in electrical technology,IEC 60417:Graphical symbols for use on equipment.Index,survey and compilation of the single sheets and IEC 60617:Graphical symbolsfor diagrams.*See web site address on title page.LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.INTERNATIONALSTANDARDIEC60601-2-30Second edition1999-12Medical electrical equipment Part 2-30:Particular requirements for the safety,including essential performance,of automatic cycling non-invasiveblood pressure monitoring equipmentAppareils lectromdicaux Partie 2-30:Rgles particulires de scurit et performancesessentielles des appareils de surveillancede la pression sanguine prleve indirectement,automatiquement et priodiquementPRICE CODE IEC 1999 Copyright-all rights reservedNo part of this publication may be reproduced or utilized in any form or by any means,electronic ormechanical,including photocopying and microfilm,without permission in writing from the publisher.International Electrotechnical Commission3,rue de Varemb Geneva,SwitzerlandTelefax:+41 22 919 0300e-mail:inmailiec.ch IEC web site http:/www.iec.chXFor price,see current catalogue Commission Electrotechnique Internationale International Electrotechnical CommissionLICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.2 60601-2-30 IEC:1999(E)CONTENTSPageFOREWORD.4INTRODUCTION.6ClauseSECTION ONE GENERAL1Scope and object.72Terminology and definitions.83General requirements.94General requirements for tests.105Classification.106Identification,marking and documents.10SECTION TWO ENVIRONMENTAL CONDITIONSSECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS14Requirements related to classification.1117Separation.1219Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.1220Dielectric strength.12SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS21Mechanical strength.1222Moving parts.13SECTION FIVE PROTECTION AGAINST HAZARDSFROM UNWANTED OR EXCESSIVE RADIATION36ELECTROMAGNETIC COMPATIBILITY.14SECTION SIX PROTECTION AGAINST THE HAZARDS OF IGNITIONOF FLAMMABLE ANAESTHETIC MIXTURESSECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURESAND OTHER SAFETY HAZARDS42Excessive temperatures.1744Overflow,spillage,leakage,humidity,ingress of liquids,cleaning,sterilization and disinfection,and compatibility.1845Pressure vessels and parts subject to PRESSURE.1849Interruption of the power supply.18LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.60601-2-30 IEC:1999(E)3 SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTIONAGAINST HAZARDOUS OUTPUT50Accuracy of operating data.1951Protection against hazardous output.19SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS;ENVIRONMENTAL TESTSSECTION TEN CONSTRUCTIONAL REQUIREMENTS56Components and general assembly.2557MAINS PARTS,components and lay-out.26Annex L(normative)References Publications mentioned in this standard.34Annex AA(informative)General guidance and