ISO 8359-2009 Oxygen concentrators for medical use — Safety requirements .pdf

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1、BRITISHSTANDARDBSENISO8359:2009Oxygenconcentratorsformedicaluse—Safetyrequirements(ISO8359:1996)ICS11.040.10NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBSENISO8359:2009NationalforewordThisBritishStandardistheUKimplementationofENISO8359:2009.ItisidenticaltoISO8359:1996

2、.ItsupersedesBSENISO8359:1997whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/121/5,Lungventilators,trachealtubesandrelatedequipment.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurportto

3、includeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwasAmendments/corrigendaissuedsincepublicationpublishedundertheauthorityoftheStandardsPolicyandStrategyDat

4、eCommentsCommitteeon31July2009.©BSI2009ISBN9780580650208EUROPEANSTANDARDENISO8359NORMEEUROPÉENNEEUROPÄISCHENORMApril2009ICS11.040.10SupersedesENISO8359:1996EnglishVersionOxygenconcentratorsformedicaluse-Safetyrequirements(ISO8359:1996)Concentrateursd'oxygèneàusagemédical-Prescription

5、sSauerstoff-KonzentratorenfürmedizinischeZwecke-desécurité(ISO8359:1996)Sicherheitsanforderungen(ISO8359:1996)ThisEuropeanStandardwasapprovedbyCENon21March2009.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthest

6、atusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguage

7、madebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCENManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,I

8、celand,Irela