ISO／DIS 14708-4：2020.docx

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1、DRAFTINTERNATIONA1STANDARDISO/DIS14708-4IS0TC150SC6Votingbeginson:2023-04-02Secretariat:ANSIVotingterminateson:2023-06-25Imp1antsforsurgeryActiveimp1antab1emedica1devicesPart4:Imp1antab1einfusionpumpsystemsImp1antsChirurgicaux-Dispositifsmedicauimp1antab1esactifs一Partie4:Pompesd,infusionenimp1antICS

2、:11.040.40THISDOCUMENTISADRAFTCIRCU1ATEDFORCOMMENTANDAPPROVA1.ITISTHEREFORESUBJECTTOCHANGEANDMAYNOTBEREFERREDTOSANINTERNATIONA1STANDARDUNTI1PUB1ISHEDASSUCH.INADDITIONTOTHEIREVA1UATIONASBEINGACCEPTAB1EFORINDUSTRIA1TECHNO1OGICA1,COMMERCIA1ANDUSERPURPOSES.DRAFTINTERNATIONA1STANDARDSMAYONOCCASIONHAVETOB

3、ECONSIDEREDINTHE1IGHTOFTHEIRPOTENTIA1TOBECOMESTANDARDSTOWHICHREFERENCEMAYBEMADEINNATIONA1REGU1ATIONS.RECIPIENTSOFTHISDRAFTAREINVITEDTOSUBMIT.WITHTHEIRCOMMENTS.NOTIFICATIONOFANYRE1EVANTPATENTRIGHTSOFWHICHTHEYAREAWAREANDTOPROVIDESUPPORTINGDOCUMENTATION.Thisdocumentiscircu1atedasreceivedfromthecommitte

4、esecretariat.ISO/CENPARA11E1PROCESSINGReferencenumberISO/DIS14708-4:2023(E)COPYRIGHTPROTECTEDDOCUMENTISO2023A11rightsreserved.Un1essotherwisespecied,orrequiredinthecontextofitsimp1ementation,nopartofthispub1icationmaybereproducedoruti1izedotherwiseinanyformorbyanymeans,e1ectronicormechanica1,inc1udi

5、ngphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1owor!SO,smemberbodyinthecountryoftherequesterISOcopyrightofficeCP401Ch.deB1andonnet8CH-1214VernieGenevaPhone:*41227490111Fax:41227490947Emai1:copyrightiso.orgWebsite:ww

6、w.iso.orgPub1ishedinSwitzer1and2345678910111213141516171819202122232425PageContentsForewordIntroductionScopeNorinativercfereBices1Symbo1sandabbreviatedterms3Genera!requirementsforactiveimp1antab1emedica1devices35.1 Genera1requirementsforon-imp1antab1eparts35.3 Usabi1ityofnon-imp1antab1eparts35.4 Dat

7、asecurityandprotectionfromharmcausedbyunauthorizedinformationtampering35.5 Genera1requirementsforriskmanagement35.6 Misconnectionofpartsoftheactiveimp1antab1emedica1device3Requirementsforparticu1aractiveimp1antab1emedica1devices46.1 Imp1antab1einfusionpumpsystemspecifications46.2 Septumpuncturetest4

8、Genera1arrangementofthepackaging5Genera1markingsforactiveimp1antab1emedica1devices5Markingsonthesa1espackaging.6Constructionofthesa1espackaging6Markingsonthesteri1epack6Constructionofthenon-reusab1epack7Markingsontheactiveimp1antab1emedica1device7Protectionfromunintentiona1bio1ogica1effectscausedbyt

9、heactiveimp1antab1emedICa1deV1CeProtectionfromharmtothepatientorusercausedbyexterna1physica1featuresoftheactiveIiT)P1a11tab1eIT1ed1Ca1device8Protectionfromharmtothepatientcausedbye1ectricity一.8Protectionfromharmtothepatientcausedbyheat8Protectionfromionizingradiationre1easedoremittedfromtheactiveimp

10、1antab1emedica1device9Protectionfromunintendedeffectscausedbytheactiveimp1antab1emedica1device9Protectionoftheactiveimp1antab1emedica1devicefromdamagecausedbyexterna1defibri11ators9Protectionoftheactiveimp1antab1emedica1devicefromchangescausedbyhigh-powere1ectrica1e1dsapp1ieddirect1ytothepatient10Pr

11、otectionoftheactiveimp1antab1emedica1devicefromchangescausedbyProtectionoftheactiveimp1antab1emedica1devicefrommechanica1forces11Protectionoftheactiveimp1antab1emedica1devicefromdamagecausedbyProtectionoftheactiveimp1antab1emedica1devicefromdamagecausedbyatmosphericpressurechanges1226 Protectionofth

12、eactiveimp1antab1emedica1devicefromdamagecausedby27 Protectionoftheactiveimp1antab1emedica1devicefrome1ectromagneticnon-radatoTi12271GCnCI1227.2 Testconditions1227.2.1 AcceptanceCriteria.一1227.2.2 Testconfiguration1327.2.3 Operatingfunctions,modes,andsettings.1327.3 DoCUi11entat】onI27.4 Protectionfr

13、omstaticmagneticfie1dsoff1uxdensityupto50mT1427.5 Protectionfrommagneticfie1dsoverthefrequencyrange16Hzto26MHz1427.6 ProtectionfromEMdisturbancesoverthefrequencyrange80MHZto2,7GHz1627.7 Protectionfromproximityfie1dsduetoRFwire1esscommunicationsequipment1727.8 OPtiOna1CharaCteriZationtesting1728 Acco

14、mpanyingdocumentation18AnnexA(informative)Re1ationshipbetweenthefundamenta1princip1esinISO/TR14283andthec1ausesofthisdocument20AIiIieXB(nft5rma11e)Ra11。na1CAnnexC(informative)Guidanceonthea11ocationofrequirementstonon-imp1antab!epartsconnectedtoapowersource49AnnexZ(informative)ARe1ationshipbetweenth

15、isEuropeanstandardandtheGenera1SafetyandPerformanceRequirementsofRegu1ation(EU)2017/745aimedtobecovered56Bib1iography67ForewordISO(theInternationa1OrganizationforStandardization)isawor1dwidefederationofnationa1standardsbodies(ISOmemberbodies).TheworkofpreparingInternationa1Standardsisnorma11ycarriedoutthroughISOtechnica1committees.Eachmemberbodyinterestedinasubjectforwhichatechnica1committeehasbeenestab1ishedhastherighttoberepresentedonthatcommittee.Internationa1organizations,