IEC_60601-2-12-2001.pdf

INTERNATIONALSTANDARDIEC60601-2-12ISO 10651-1Second edition2001-10Medical electrical equipment Part 2-12:Particular requirements for the safety of lungventilators Critical care ventilatorsAppareils lectromdicaux Partie 2-12:Rgles particulires de scurit pour ventilateurspulmonaires Ventilateurs pour utilisation en soins intensifsReference numberIEC 60601-2-12:2001(E)LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.Publication numberingAs from 1 January 1997 all IEC publications are issued with a designation in the60000 series.For example,IEC 34-1 is now referred to as IEC 60034-1.Consolidated editionsThe IEC is now publishing consolidated versions of its publications.For example,edition numbers 1.0,1.1 and 1.2 refer,respectively,to the base publication,thebase publication incorporating amendment 1 and the base publication incorporatingamendments 1 and 2.Further information on IEC publicationsThe technical content of IEC publications is kept under constant review by the IEC,thus ensuring that the content reflects current technology.Information relating tothis publication,including its validity,is available in the IEC Catalogue ofpublications(see below)in addition to new editions,amendments and corrigenda.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 also available from the following:IEC Web Site(www.iec.ch)Catalogue of IEC publicationsThe on-line catalogue on the IEC web site(www.iec.ch/catlg-e.htm)enablesyou to search by a variety of criteria including text searches,technicalcommittees and date of publication.On-line information is also available onrecently issued publications,withdrawn and replaced publications,as well ascorrigenda.IEC Just PublishedThis summary of recently issued publications(www.iec.ch/JP.htm)is alsoavailable by email.Please contact the Customer Service Centre(see below)forfurther information.Customer Service CentreIf you have any questions regarding this publication or need further assistance,please contact the Customer Service Centre:Email:custserviec.chTel:+41 22 919 02 11Fax:+41 22 919 03 00LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.INTERNATIONALSTANDARDIEC60601-2-12ISO 10651-1Second edition2001-10Medical electrical equipment Part 2-12:Particular requirements for the safety of lungventilators Critical care ventilatorsAppareils lectromdicaux Partie 2-12:Rgles particulires de scurit pour ventilateurspulmonaires Ventilateurs pour utilisation en soins intensifsPRICE CODE IEC 2001 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 catalogueLICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.2 60601-2-12 IEC:2001(E)CONTENTSFOREWORD.4INTRODUCTION.6SECTION ONE GENERAL1Scope and object.72Terminology and definitions.83General requirements.124General requirements for tests.125Classification.126Identification,marking and documents.127Power input.16SECTION TWO ENVIRONMENTAL CONDITIONS8Basic safety categories.169Removable protective means.1610Environmental conditions.16SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS13General.1714Requirements related to classification.1715Limitation of voltage and/or energy.1716ENCLOSURES and PROTECTIVE COVERS.1717Separation.1818Protective earthing,functional earthing and potential equalization.1819Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.1820Dielectric strength.18SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS21Mechanical strength.1822Moving parts.1823Surfaces,corners and edges.1824Stability in NORMAL USE.1825Expelled parts.1826Vibration and noise.1827Pneumatic and hydraulic power.1928Suspended masses.19SECTION FIVE PROTECTION AGAINST HAZARDSFROM UNWANTED OR EXCESSIVE RADIATION29X-radiation.1930Alpha,beta,gamma,neutron radiation and other particle radiation.1931Microwave radiation.1932Light radiation(including lasers).1933Infra-red radiation.1934Ultra-violet radiation.19LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.60601-2-12 IEC:2001(E)3 35Acoustical energy(including ultrasonics).1936Electromagnetic compatibility.19SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITIONOF FLAMMABLE ANAESTHETIC MIXTURES37Locations and basic requirements.2038Marking,ACCOMPANYING DOCUMENTS.2039Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT.2040Requirements and tests for CATEGORY AP EQUIPMENT,parts and components