INTERNATIONAL

STANDARD

ISO

80601-2-55

Secondedition2018-02

Medicalelectricalequipment—

Part2-55:

Particularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitors

Appareilsélectromédicaux—

Partie2-55:Exigencesparticulièresrelativesàlasécuritédebaseetauxperformancesessentiellesdesmoniteursdegazrespiratoires

ReferencenumberISO80601-2-55:2018(E)

?ISO2018

ISO80601-2-55:2018(E)

COPYRIGHTPROTECTEDDOCUMENT

?ISO2018

Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.

ISOcopyrightoffice

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CH-1214Vernier,Geneva,Switzerland

Tel.+41227490111

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copyright@

PublishedinSwitzerland

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Contents

Page

Foreword iv

Introduction vi

201.1Scope,object,andrelatedstandards

1

201.2Normativereferences

3

201.3Termsanddefinitions

4

201.4Generalrequirements

6

201.5GeneralrequirementsfortestingofMEEQUIPMENT

7

201.6ClassificationofMEEQUIPMENTandMESYSTEMS

7

201.7MEEQUIPMENTidentification,marking,anddocuments

7

201.8ProtectionagainstelectricalHAZARDSfromMEEQUIPMENT

13

201.9ProtectionagainstMECHANICALHAZARDSofMEEQUIPMENTandMESYSTEMS

14

201.10ProtectionagainstunwantedandexcessiveradiationHAZARDS

14

201.11ProtectionagainstexcessivetemperaturesandotherHAZARDS

14

201.12Accuracyofcontrolsandinstrumentsandprotectionagainsthazardousoutputs

16

201.13HAZARDOUSSITUATIONSandfaultconditions

22

201.14PROGRAMMABLEELECTRICALMEDICALSYSTEMS(PEMS)

22

201.15ConstructionofMEEQUIPMENT

22

201.16MESYSTEMS

24

201.17ElectromagneticcompatibilityofMEEQUIPMENTandMESYSTEMS

24

201.101*Interferinggasandvapoureffects

24

201.102*Gasleakage

25

201.103*PortconnectorsforDIVERTINGRGMs

25

201.104*Samplingflowrate

25

201.105*Contaminationofbreathingsystems

25

201.106FUNCTIONALCONNECTION

25

202Electromagneticdisturbances—Requirementsandtests

27

206USABILITY

27

208Generalrequirements,testsandguidanceforALARMSYSTEMSinMEDICALELECTRICAL

EQUIPMENTandMEDICALELECTRICALSYSTEMS

28

211Generalrequirements,testsandguidanceformedicalelectricalequipmentand

medicalelectricalsystemsusedinthehomehealthcareenvironment

30

212Generalrequirements,testsandguidanceforMEDICALELECTRICALEQUIPMENTand

MEDICALELECTRICALSYSTEMSintendedforuseintheEMERGENCYMEDICALSERVICES

ENVIRONMENT

30

AnnexC(informative)GuidetomarkingandlabellingrequirementsforMEEQUIPMENTand

MESYSTEMS

31

AnnexD(informative)Symbolsonmarking

35

AnnexAA(informative)Particularguidanceandrationale

38

AnnexBB(informative)Testgasmixturesforcalibration

48

AnnexCC(informative)Datainterfacerequirements

49

AnnexDD(informative)Alphabetizedindexofdefinedtermsusedinthisdocument

54

Bibliography

61

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Foreword

ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon‐governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.

TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(see/directives).

Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(see/patents).

Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.

Foranexplanationonthevoluntarynatureofstandards,themeaningofISOspecifictermsand

expressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT),seethefollowingURL:/iso/foreword.html.

ThisdocumentwaspreparedbyTechnicalCommitteeISO/TC121,Anaestheticandrespiratory

equipment,SubcommitteeSC1,Breathingattachmentsandanaestheticmachines,andTechnicalCommitteeIEC/TC62,Electricalequipmentinmedicalpractice,SubcommitteeSCD,Electricalequipment.

Thissecondeditioncancelsandreplacesthefirstedition(ISO80601‐2‐55:2011),whichhasbeentechnicallyrevised.

Themainchangescomparedtothepreviouseditionareasfollows:

—additionalrequirementsonrespiratorygasmonitorsforuseduringprofessionaltransportofapatientoutsideahealthcarefacilityhavebeendeletedbecausethesearenowcoveredbyIEC60601‐1‐12;

—requirementsonmarking,warningandsafetynotices,aswellasaccompanyingdocumentshavebeenupdated;

—andhavebeenrevisedtodistinguishbetweenrequirementsforstand‐alonerespiratorygasmonitorsandrequirementsforrespiratorygasmonitorsthatareincorporatedintoanothermedicalelectricalequipment;

—requirementsonportconnectorsfordivertingrespiratorygasmonitorshavebeenrevised;

eannexondatainterfacerequirements;

—aiconnectionhasbeenadded(see201.106)accompaniedbythe

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—Clause202hasbeenupdatedtoalignwithIEC60601‐1‐2:2014;

—Clause208hasbeenupdatedtoalignwithIEC60601‐1‐8:2006/Amd1:2012;

—IEC60601‐1‐9hasbeenexcluded;

—AnnexBBhasbeendeleted;

—requirementsoncalibration/zeroinghavebeenadded.

AlistofallthepartsofISO80601canbefoundontheISOwebsite.

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Introduction

Inthisdocument,thefollowingprinttypesareused:

—requirementsanddefinitions:romantype.

—compliancechecks:italictype.

—informativematerialappearingoutsideoftablessuchasnotes,examplesandreferences:smallertype.Normativetextoftablesisalsoinasmallertype.

—termsdefinedinClause3ofthegeneralstandard,inthisdocumentorasnoted:SMALLCAPITALS.

Inreferringtothestructureofthisdocument,

—“clause”meansoneofthe17numbereddivisionswithinthetableofcontents,inclusiveofallsubdivisions(e.g.Clause7includes7.1,7.2,etc.),and

—“subclause”meansanumberedsubdivisionofaclause(e.g.201.7.1,201.7.2andareallsubclausesofClause201.7).

Referencestoclauseswithinthisdocumentareprecededbytheterm“Clause”followedbytheclausenumber.Referencestosubclauseswithinthisdocumentarebynumberonly.

Inthisdocument,theconjunctive“or”isusedasan“inclusiveor”,soastatementistrueifanycombinationoftheconditionsistrue.

TheverbalformsusedinthisdocumentconformtousagedescribedinISO/IECDirectives,Part2,Clause7.Forthepurposesofthisdocument,theauxiliaryverb

—“shall”meansthatcompliancewitharequirementoratestismandatoryforcompliancewithdocument,

—“should”meansthatcompliancewitharequirementoratestisrecommendedbutisnotmandatoryforcompliancewiththisdocument,and

—“may”isusedtodescribeapermissiblewaytoachievecompliancewitharequirementortest.

Anasterisk(*)asthefirstcharacterofatitleoratthebeginningofaparagraphortabletitleindicatesthatthereisguidanceorrationalerelatedtothatiteminAnnexAA.

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INTERNATIONALSTANDARD

ISO80601-2-55:2018(E)

Medicalelectricalequipment—

Part2‐55:

Particularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitors

201.1Scope,objectandrelatedstandards

IEC60601‐1:2005+Amd1:2012,Clause1applies,exceptasfollows:

201.1.1*Scope

IEC60601‐1:2005+Amd1:2012,1.1isreplacedby:

ThisdocumentspecifiesparticularrequirementsfortheBASICSAFETYandESSENTIALPERFORMANCEofaRESPIRATORYGASMONITOR(RGM),hereafterreferredtoasMEEQUIPMENT,intendedforCONTINUOUSOPERATIONforusewithaPATIENT.

Thisdocumentspecifiesrequirementsfor

—anaestheticgasmonitoring,

—carbondioxidemonitoring,and

—oxygenmonitoring.

NOTE1AnRGMcanbeeitherstand‐aloneMEEQUIPMENTorintegratedintootherequipment,e.g.ananaestheticworkstationoraventilator.

ThisdocumentisnotapplicabletoanRGMintendedforusewithflammableanaestheticagents.

IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonlyortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.

HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisdocumentarenotcoveredbyspecificrequirementsinthisdocumentexceptinIEC60601‐1:2005+Amd1:2012,7.2.13and8.4.1.

NOTE2AdditionalinformationcanbefoundinIEC60601‐1:2005+Amd1:2012,4.2.

201.1.2Object

IEC60601‐1:2005+Amd1:2012,1.2isreplacedby:

TheobjectofthisdocumentistoestablishparticularBASICSAFETYandESSENTIALPERFORMANCErequirementsforanRGM(asdefinedin201.3.210)anditsACCESSORIES.

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NOTEACCESSORIESareincludedbecausethecombinationoftheRGMandtheACCESSORIESneedstobesafe.ACCESSORIEScanhaveasignificantimpactontheBASICSAFETYandESSENTIALPERFORMANCEofanRGM.

201.1.3Collateralstandards

IEC60601‐1:2005+Amd1:2012,1.3applieswiththefollowingaddition:

ThisdocumentreferstothoseapplicablecollateralstandardsthatarelistedinIEC60601‐1:2005+Amd1:2012,Clause2,aswellasthoselistedin201.2ofthisdocumentandtothefollowingexceptions:

IEC60601‐1‐3:2008andIEC60601‐1‐9:2007+Amd1:2013donotapply.

201.1.4Particularstandards

IEC60601‐1:2005+Amd1:2012,1.4isreplacedby:

IntheIEC60601series,particularstandardscanmodify,replaceordeleterequirementscontainedinthegeneralstandard,includingthecollateralstandards,asappropriatefortheparticularMEEQUIPMENTunderconsideration,andmayaddotherBASICSAFETYorESSENTIALPERFORMANCErequirements.

ArequirementofaparticularstandardtakespriorityoverIEC60601‐1:2005+Amd1:2012orthecollateralstandards.

Forbrevity,IEC60601‐1:2005+Amd1:2012isreferredtointhisdocumentasthegeneralstandard.Collateralstandardsarereferredtobytheirdocumentnumber.

Thenumberingofclausesandsubclausesofthisdocumentcorrespondstothoseofthegeneralstandardwiththeprefix“201”(e.g.201.1inthisdocumentaddressesthecontentofClause1ofthegeneralstandard)orapplicablecollateralstandardwiththeprefix“2xx”wherexxisthefinaldigitsofthecollateralstandarddocumentnumber(e.g.202.4addressesthecontentofIEC60601‐1‐2,Clause4collateralstandard,208.4addressesthecontentofIEC60601‐1‐8,Clause4collateralstandard,etc.).Thechangestothetextofthegeneralstandardarespecifiedbytheuseofthefollowingwords:

—“Replacement”meansthattheclauseorsubclauseofIEC60601‐1:2005+Amd1:2012ortheapplicablecollateralstandardisreplacedcompletelybythetextofthisdocument.

—“Addition”meansthatthetextofthisdocumentisadditionaltotherequirementsofIEC60601‐1:2005+Amd1:2012ortheapplicablecollateralstandard.

—“Amendment”meansthattheclauseorsubclauseofIEC60601‐1:2005+Amd1:2012ortheapplicablecollateralstandardisamendedasindicatedbythetextofthisdocument.

Subclausesorfiguresthatareadditionaltothoseofthegeneralstandardarenumberedstartingfrom201.101,additionalannexesareletteredAA,BB,etc.,andadditionalitemsaa),bb),etc.

Subclausesorfiguresthatareadditionaltothoseofacollateralstandardarenumberedstartingfrom20x,where“x”isthenumberofthecollateralstandard,e.g.202forIEC60601‐1‐2,203forIEC60601‐1‐3,etc.

Theterm“thisstandard”isusedtomakereferencetoIEC60601‐1:2005+Amd1:2012,anyapplicablecollateralstandards,andthisdocumenttakentogether.

Wherethereisnocorrespondingclauseorsubclauseinthisdocument,theclauseorsubclauseofIEC60601‐1:2005+Amd1:2012ortheapplicablecollateralstandard,althoughpossiblynotrelevant,applieswithoutmodification;whereitisintendedthatanypartofIEC60601‐1:2005+Amd1:2012ortheapplicablecollateralstandard,althoughpossiblyrelevant,isnottobeapplied,astatementtothateffectisgiveninthisdocument.

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201.2Normativereferences

Thefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.For

undatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.

IEC606011:20051+Amd1:2012,Clause2applies,exceptasfollows:

Replacement:

IEC60601‐1‐2:2014,Medicalelectricalequipment—Part1-2:Generalrequirementsforbasicsafetyandessentialperformance—Collateralstandard:Electromagneticdisturbances—Requirementsandtests

IEC60601‐1‐6:20102+Amd1:2013,Medicalelectricalequipment—Part1-6:Generalrequirementsforbasicsafetyandessentialperformance—Collateralstandard:Usability

IEC60601‐1‐8:20063+Amd1:2012,Medicalelectricalequipment—Part1-8:Generalrequirementsforbasicsafetyandessentialperformance—Collateralstandard:Generalrequirements,testsandguidanceforalarmsystemsinmedicalelectricalequipmentandmedicalelectricalsystems

Addition:

ISO7000:2014,Graphicalsymbolsforuseonequipment—Registeredsymbols

ISO7010:2011,Graphicalsymbols—Safetycoloursandsafetysigns—Registeredsafetysigns

ISO14937:2009,Sterilizationofhealthcareproducts—Generalrequirementsforcharacterizationofasterilizingagentandthedevelopment,validationandroutinecontrolofasterilizationprocessformedical

devices

ISO15223‐1:2017,Medicaldevices—Symbolstobeusedwithmedicaldevicelabels,labellingandinformationtobesupplied—Part1:Generalrequirements

ISO17664:20044,Sterilizationofmedicaldevices—Informationtobeprovidedbythemanufacturerfortheprocessingofresterilizablemedicaldevices

ISO80369(allparts),Smallboreconnectorsforliquidsandgasesinhealthcareapplications

ISO80601‐2‐13:2011+Amd1:2015andAmd2:—5,Medicalelectricalequipment—Part2-13:Particularrequirementsforbasicsafetyandessentialperformanceofananaestheticworkstation

IEC60068‐2‐27:2008,Environmentaltesting—Part2-27:Tests—TestEaandguidance:Shock

1Aconsolidatededition,IEC60601‐1:2012,whichincludesIEC60601‐1:2005anditsamendment(IEC60601‐1:2005/Amd1:2012)isavailable.

2Aconsolidatededition,IEC60601‐1‐6:2013,whichincludesIEC60601‐1‐6:2010anditsamendment(IEC60601‐1‐6:2010/Amd1:2013)isavailable.

3Aconsolidatededition,IEC60601‐1‐8:2012,whichincludesIEC60601‐1‐8:2006anditsamendment

(IEC60601‐1‐8:2006/Amd1:2012)isavailable.

4Underrevision.

5Tobepublished.StageattimeofpublicationISO80601‐2‐13:2011+DAmd2:2017.

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IEC60068‐2‐64:2008,Environmentaltesting—Part2-64:Testmethods—TestFh:Vibration,broad

bandrandomandguidance

IEC60529:1989

6

+Amd1:1999andAmd2:2013,Degreesofprotectionprovidedbyenclosures(IPcode)

IEC60601‐1‐11:2015,Medicalelectricalequipment—Part1-11:Generalrequirementsforbasicsafetyandessentialperformance—CollateralStandard:Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironment

IEC60601‐1‐12:2014,Medicalelectricalequipment—Part1-12:Generalrequirementsforbasicsafetyandessentialperformance—CollateralStandard:Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsintendedforuseintheemergencymedicalservicesenvironment

IEC62570:2014,Standardpracticeformarkingmedicaldevicesandotheritemsforsafetyinthemagneticresonanceenvironment

201.3Termsanddefinitions

Forthepurposesofthisdocument,thetermsanddefinitionsgiveninIEC60601‐1:2005+Amd1:2012,IEC60601‐1‐2,IEC60601‐1‐6:2010+Amd1:2013,IEC60601‐1‐8:2006+Amd1:2012,IEC60601‐1‐11,IEC60601‐1‐12andISO80601‐2‐13:2011+Amd1:2015andthefollowingapply.

ISOandIECmaintainterminologicaldatabasesforuseinstandardizationatthefollowingaddresses:

—IECElectropedia:availableat

/

—ISOOnlinebrowsingplatform:availableat

/obp

Addition:

NOTEAnalphabeticallistofdefinedtermsisgiveninAnnexDD.

201.3.201

DIVERTINGRGM

SIDESTREAMMONITOR

RGMthattransportsaportionofrespiratorygasesfromtheSAMPLINGSITEthroughaSAMPLINGTUBEtotheSENSOR,whichisremotefromtheSAMPLINGSITE

201.3.202

DRIFT

changeintheGASREADINGofanRGM,foragivenGASLEVELoverastatedperiodoftime,underreferenceconditionsthatremainconstant

201.3.203

GASLEVEL

contentofaspecificgasinagaseousmixture

6Aconsolidatededition,IEC60529:2013,whichincludesIEC60529:1989anditsamendments

(IEC60529:1989/Amd1:1999andIEC60529:1989/Amd2:2013)isavailable.

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201.3.204

GASREADING

measuredGASLEVELasdisplayedbytheRGM

201.3.205

MEASUREMENTACCURACY

qualitywhichcharacterizestheabilityofanRGMtogiveindicationsapproximatingtothetruevalueofthequantitymeasured

201.3.206

MINIMUMALVEOLARCONCENTRATION

MAC

alveolarconcentrationofaninhaledanaestheticagentthat,intheabsenceofotheranaestheticagents

andatequilibrium,prevents50%ofsubjectsfrommovinginresponsetoastandardsurgicalstimulus

Note1toentry:Forthepurposesofthisdocument,MACiscalculatedfromtheend‐tidalGASLEVEL.

201.3.207

NON-DIVERTINGRGM

MAINSTREAMMONITOR

RGMthatusesaSENSORattheSAMPLINGSITE

201.3.208

PARTIALPRESSURE

pressurethateachgasinagasmixturewouldexertifitaloneoccupiedthevolumeofthemixtureatthesametemperature

201.3.209

RESERVEELECTRICALPOWERSOURCE

partoftheMEEQUIPMENTthattemporarilysuppliespowertotheelectricalsystemintheeventofaninterruptionoftheprimaryelectricalsupply

201.3.210

RESPIRATORYGASMONITOR

RGM

MEEQUIPMENTintendedtomeasuretheGASLEVELorPARTIALPRESSUREofoneormoregasesinrespiratorygas

Note1toentry:TheRGMconsistsofequipment,asspecifiedintheACCOMPANYINGDOCUMENTSfortheINTENDEDUSEoftheRGM,includingaSENSOR,display,ALARMSYSTEM,ACCESSORIESand,foraDIVERTINGRGM,theSAMPLINGTUBEandexhaustport.

201.3.211

RISETIME

RT

timetakenforavaluetorisefrom10%to90%oftheindicatedreading

[SOURCE:ISO23747:2015,3.9,modified—replaced“achievedPEF(peakexpiratoryflowrate)”by“indicatedreading”and“flowrate”by“avalue”.]

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201.3.212

SAMPLINGSITE

locationoftheSENSORforaNON‐DIVERTINGRGMorlocationatwhichrespiratorygasesaredivertedformeasurementtoaremoteSENSORforaDIVERTINGRGM

201.3.213

SAMPLINGTUBE

conduitforthetransferofgasfromtheSAMPLINGSITEtotheSENSORinaDIVERTINGRGM

201.3.214

SENSOR

partoftheRGMthatissensitivetothepresenceoftherespiratorygas

201.3.215

TOTALSYSTEMRESPONSETIME

timefromastepfunctionchangeinGASLEVELattheSAMPLINGSITEtotheachievementof90%ofthefinalGASREADINGoftheRGM

201.3.216

VOLUMEPERCENT

volumeofagasinamixture,expressedasapercentageofthetotalvolume

201.4Generalrequirements

IEC60601‐1:2005+Amd1:2012,Clause4applies,exceptasfollows:

201.4.3ESSENTIALPERFORMANCE

IEC60601‐1:2005+Amd1:2012,4.3applies,exceptasfollows:

Additionalsubclause:

01

*AdditionalrequirementsforESSENTIALPERFORMANCE

AdditionalESSENTIALPERFORMANCErequirementsarefoundinthesubclauseslistedinTable201.101.

Table201.101—DistributedESSENTIALPERFORMANCErequirements

Requirement

Subclause

MEASUREMENTACCURACYaandALARMCONDITIONfortheGASREADING

orgenerationofaTECHNICALALARMCONDITION

01

01.1,

aMethodsofevaluatingMEASUREMENTACCURACYasacceptancecriteriafollowingspecifictestsrequiredbythisdocumentarefoundin202.8.1.

201.4.6*MEEQUIPMENTorMESYSTEMpartsthatcontactthePATIENT

Amendment(addatendof4.6priortothecompliancecheck):

PartsandACCESSORIESofanRGMintendedtobeconnectedwiththebreathingsystemshallbesubjecttotherequirementsforAPPLIEDPARTSaccordingtothissubclause.

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201.5GeneralrequirementsfortestingofMEEQUIPMENT

IEC60601‐1:2005+Amd1:2012,Clause5applies.

201.6ClassificationofMEEQUIPMENTandMESYSTEMS

IEC60601‐1:2005,Clause6applies.

201.7MEEQUIPMENTidentification,marking,anddocuments

IEC60601‐1:2005+Amd1:2012,Clause7applies,exceptasfollows.

*ConsultACCOMPANYINGDOCUMENTS

IEC60601‐1:2005+Amd1:2012,7.2.3applies,exceptasfollows.

Replacement:

TheRGMshallbemarkedwiththesafetysignforthemandatoryaction:“Followinstructionsforuse”,ISO7010‐M002(seeIEC60601‐1:2005+Amd1:2012,TableD.2,Number10).

IfanRGMisincorporatedasamoduleintoahousingofanotherMEEQUIPMENTthatalreadyismarkedwithasafetysign,itdoesnotneedtobemarkedadditionally.

Additionalsubclauses:

.101AdditionalrequirementsforACCESSORIES

ForanACCESSORYintendedforsinglePATIENTuse,thepackageortheACCESSORYitselfshallbemarkedwithanindicationthattheACCESSORYisforsinglePATIENTuse.

Checkcompliancebyinspection.

3.101*Additionalrequirementsforphysiologicaleffects(safetysignsandwarningstatements)

MEEQUIPMENT,partsorACCESSORIEScontainingnaturalrubberlatexshallbeCLEARLYLEGIBLYmarkedascontainingnaturalrubberlatex.ISO15223‐1:2016,5.4.5(seeTable201.D.2.101,symbol10)maybeused.Allcomponentscontainingnaturalrubberlatexshallbedisclosedassuchintheinstructionsforuse.

Checkcompliancebyinspection.

7.101Additionalrequirementsforprotectivepackaging

PackagesofMEEQUIPMENT,partsorACCESSORIESshallbeCLEARLYLEGIBLYmarked

a)withthefollowing:

—adescriptionofthecontents;

—anidentificationreferencetothebatch,typeorserialnumberorISO15223‐1:2016,5.1.5,5.1.6or5.1.7(seeTable201.D.2.101,symbols7to9);

—forpackagescontainingnaturalrubberlatex,theword“LATEX”,orISO15223‐1:2016,5.4.5(seeTable201.D.2.101,symbol10);

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—ifapplicable,theword“S