ISO116082 中英对照版Word格式.docx
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ISO116082 中英对照版Word格式.docx
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—Part2:
Needles
第二部分:
针
INTERNATIONALSTANDARD
ISO11608-2
Secondedition
2012-04-01
Contents目录Page
Foreword..............................................................................................iv
Introduction......................................................................................v
1Scope.................................................................................................1
2Normativereferences........................................................................1
3Termsanddefinitions.....................................................1
4Requirements..................................................................................3
4.1Materials......................................................................................3
4.2Dimensions....................................................................................3
4.3Determinationofflowratethroughtheneedle.............3
4.4Bondbetweenhubandneedletube............................................3
4.5Needlepoints................................................................................4
4.6Freedomfromdefects....................................................................4
4.7Lubrication.....................................................................................4
4.8Dislocationofmeasuringpointatpatientend.....................4
4.9Determinationoffunctionalcompatibilitywithneedle-basedinjectionsystems........4
4.10Easeofassemblyanddisassembly...................................................4
4.11Sterility..................................................................................4
5Sampling.................................................................................................4
6Pre-conditioningofneedles.............................................................5
6.1Pre-conditioninginadry-heatatmosphere..............................5
6.2Pre-conditioninginacold-storageatmosphere......................5
6.3Pre-conditioninginacyclicalatmosphere................................5
7Standardatmosphereandapparatusfortests..........................................6
7.1General........................................................................................................6
7.2Standardtestatmosphere........................................................................6
7.3Testgauge................................................................................6
8Determinationofdislocationofmeasuringpointatpatientend......7
9Bondbetweenhubandneedletube....................................................8
10Packaging.............................................................................................8
11Testmethodforvalidatingthecompatibilityofneedlesandinjectorsystems...8
11.1Principle................................................................................................8
11.2Apparatusandequipment...................................................................................9
11.3Samplequantityrequirements.........................................................9
11.4Procedure..........................................................................................9
11.5Acceptancecriteria...............................................................11
11.6Testreport..................................................................................12
12Informationsuppliedbythemanufacturer.....................................................12
12.1General...............................................................................................12
12.2Marking.................................................................................................12
12.3Instructionsforuse...........................................................................................14
AnnexA(normative)Determinationofflowratethroughneedle..................15
Bibliography.................................................................................................................17
Foreword前言
ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmat
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