1、BRITISH STANDARD BS EN 13726-3:2003 Non-active medical devices Test methods for primary wound dressings Part 3: Waterproofness The European Standard EN 13726-3:2003 has the status of a British Standard ICS 11.120.20 BS EN 13726-3:2003 This British Standard was published under the authority of the St
2、andards Policy and Strategy Committee on 13 May 2003 BSI 13 May 2003 ISBN 0 580 41799 9 National foreword This British Standard is the official English language version of EN 13726-3:2003. The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices
3、, to Subcommittee CH/205/1, Medical textiles, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this docum
4、ent may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract.
5、Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for cha
6、nge, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 6, an inside back cover and a back cover. The BSI copyright dat
7、e displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN137263 April2003 ICS11.120.20 Englishversion NonactivemedicaldevicesTestmethodsforprimarywound dressingsPart3:Waterproo
8、fness DispositifsmdicauxnonactifsMthodesdessaipourles pansementsprimairesencontactaveclaplaiePartie3: Rsistancelapntrationdeleau NichtaktiveMedizinproduktePrverfahrenfrprimre Verbandstoffe(Wundauflagen)Teil3:Wasserdichtheit ThisEuropeanStandardwasapprovedbyCENon21February2003. CENmembersareboundtoco
9、mplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanS
10、tandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic
11、,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Br
12、ussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN137263:2003EEN137263:2003(E) 2 Contents page Foreword3 Introduction .4 1 Scope 4 2 Termsanddefinitions. .4 3 Testmethodforwaterproofness 4 3.1 Testconditions . .4 3.2 Waterproofness4 3.2.1 S
13、ignificanceanduse .4 3.2.2 Equipment.5 3.2.3 Procedure .5 3.2.4 Calculationofresults 5 3.2.5 Testreport . .5EN137263:2003(E) 3 Foreword Thisdocument(EN137263:2003)hasbeenpreparedbyTechnicalCommitteeCEN/TC205,“Nonactivemedical devices“,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegive
14、nthestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbyOctober2003,andconflictingnationalstandardsshallbewithdrawnatthelatest byOctober2003. EN13726consistsofthefollowingPartsunderthegeneraltitle Nonactivemedicaldevices Testmethodsfor primarywounddressings: P
15、art1:Aspectsofabsorbency Part2:Moisturevapourtransmissionrateofpermeablefilmdressings Part3:Waterproofness Part4:Conformability Part5:Bacterialbarrierproperties Part6:Odourcontrol AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplemen
16、tthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal, Slovakia,Spain,Sweden,SwitzerlandandtheUnitedKingdom.EN137263:2003(E) 4 Introduction EN13726givestestmethodsanddoesnotcontainperforma
17、ncerequirements. EN137263describesatestmethodforwaterproofnessofprimarywounddressings. TestmethodsforotheraspectsofprimarywounddressingsaredescribedinotherpartsofEN13726. 1Scope ThisEuropeanStandarddescribesatestmethodfortheevaluationofwaterproofnessofprimarywounddressings whensuchclaimsaremade. 2 T
18、ermsanddefinitions ForthepurposesofthisEuropeanStandard,thefollowingtermsanddefinitionsapply: 2.1 primarywounddressing materialorcombinationofmaterials,inanyshape,formorsizethatisintendedtoremainindirectcontactwitha wound NOTE Primarywounddressingsareusedasmechanicalbarriers,fortheabsorptionortransm
19、issionofexudates,to managethemicroenvironmentofthewound,andcanenablethewoundtohealbyprimaryorsecondaryintent.Deviceswhich haveametabolic,pharmacologicalorimmunologicalinteractionastheirprimaryintentareexcluded 2.2 waterproof(ness) abilitytowithstandahydrostaticheadof500mmwaterfor300s 3 Testmethodfor
20、waterproofness 3.1Test conditions Conditionthesampleforatleast16hatof(6015)%RHandatemperatureof(212)Candcarryoutthetest inthesameenvironment. 3.2Waterproofness 3.2.1 Significanceanduse Thetestisdesignedtoassesswhetheraprimarywounddressingiswaterproof. NOTE1 Thistestmaynotbesuitableforsometypesofprim
21、arywounddressingse.g.somehydrocolloids. NOTE2 Thistestmaynotbeabletodetectthewaterproofnessofsomeslowlyhydratingprimarywounddressingswhere hydrationisnotachievedduringthedurationofthetest.EN137263:2003(E) 5 3.2.2Equipment 3.2.2.1 Apparatusformeasurementofwaterproofness(seeFigure1),consistingofacellw
22、hichallowsthe applicationofahydrostaticheadof500mmofwaterfor300stoacircularareaofthespecimenwiththesurface oppositetothewoundcontactsidetowardsthewater.Thespecimenisheldinahorizontalpositionbytworings, theloweroneformingpartofthecell.Ascrewdeviceallowsclampstobetightenedsoastopreventleakageof watero
23、rthemovementofthespecimenduringthetest.Thehydrostaticheadisgeneratedbymeansofavertical tubewithaminimuminternaldiameterof3mmconnectedtothebaseofthecell. NOTE Topreventleakagetheringsurfacesincontactwiththespecimenmayneedtobecoveredbyasuitablecoating materialsuchasrubber. 3.2.2.2 Distilled/deionisedw
24、ater. 3.2.2.3 Standardcellulosebasedfilterpaper. 3.2.3Procedure 3.2.3.1 Thespecimensshallbepreparedwithoutfolding. 3.2.3.2 Fillthecellcompletelywithpurifiedwaterat(212)C. 3.2.3.3 Placethespecimenonthelowerringbyslidingithorizontallyinsuchawayastoavoidtheinclusionof airbetweenthesurfaceofthewaterandt
25、helowersurfaceofthespecimen. 3.2.3.4 Covertheuppersurfaceofthespecimenwithadryfilterpaperlargerthanthetestarea,locatetheupper ring,andtightenthescrewdevice. 3.2.3.5 Pourwaterintothetubeuntiltherequiredlevelabovethesurfaceofthespecimenisreached. 3.2.3.6 Maintainthehydrostaticheadfor(30010)s. 3.2.3.7
26、Examinethefilterpaperforpenetrationofwaterthroughthespecimenandrecordtheresult. 3.2.3.8 Repeat3.2.3.2to3.2.3.7onafurthertwospecimens. 3.2.4 Calculationofresults Examinethefilterpaperforpenetrationofwaterthroughthespecimenandrecordtheresults.Ifwaterpenetration hasoccurredonanyofthethreespecimensthesa
27、mplehasfailedthetest. 3.2.5 Testreport Thereportshallincludeatleastthefollowinginformation: a) typeofdressing,includinglotnumber; b) anydeviationsfromthetestmethod; c) whetherthesamplehaspassedorfailedthetest; d) dateoftest; e) identityoftheperson(s)whocarriedoutthetest.EN137263:2003(E) 6 Dimensions
28、inmillimetres Key 1Pressure 2Gasket 3 Filterpaper 4Sample 5Gasket Figure1ApparatusformeasurementofwaterproofnessblankBS EN 13726-3:2003 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It pres
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