1、BRITISH STANDARD BS EN 13726-2:2002 Test methods for primary wound dressings Part 2: Moisture vapour transmission rate of permeable film dressings The European Standard EN 13726-2:2002 has the status of a British Standard ICS 11.120.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIG
2、HT LAWBS EN 13726-2:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 15 April 2002 BSI 15 April 2002 ISBN 0 580 39511 1 National
3、 foreword This British Standard is the official English language version of EN 13726-2:2002. The UK participation in its preparation was entrusted by Technical Committee CH/117, Medical textiles, to Subcommittee CH/117/1, Test methods for non-wovens for use in compresses, which has the responsibilit
4、y 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 document may be found in the BSI Standards Catalogue under the section entitle
5、d “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance
6、 with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and
7、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 9 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since
8、 publication Amd. No. Date CommentsEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13726-2 March 2002 ICS 11.120.20 English version Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings Mthodes dessai pour les pansements primaires en co
9、ntact avec la plaie - Partie 2: Permabilit la v apeur deau des pansements comprenant un film permable Prfverfahren fr primre Verbandstoffe (Wundauflagen) - Teil 2: Feuchtigkeitsdurchdringungsrate durchlssiger Folienverbnde This European Standard was approved by CEN on 22 February 2002. CEN members a
10、re bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to
11、 the Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same statu
12、s as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR S
13、TANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2002 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13726-2:2002 EEN137262:2002(E) 2 Contents page
14、 Foreword3 Introduction .4 1 Scope 5 2 Termsanddefinitions. .5 3 Testmethodsformoisturevapourtransmissionrate(MVTR)5 3.1 Testconditions . .5 3.2 MVTRofawounddressingwhenincontactwithwatervapour.5 3.3 MVTRofawounddressingwhenincontactwithliquid .7EN137262:2002(E) 3 Foreword ThisdocumentEN137262:2002h
15、asbeenpreparedbyTechnicalCommitteeCEN/TC205“Nonactivemedical devices“,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbySeptember2002,andconflictingnationalstandardsshallbewithdrawnatthe la
16、testbySeptember2002. ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropean FreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). EN13726willconsistofthefollowingpartsunderthegeneraltitleTestmethodsforprimarywounddressings: Part1:Aspectsofabsorbency
17、Part2:Moisturevapourtransmissionrateofpermeablefilmdressings Part3:Waterproofness Part4:Conformability Part5:Bacterialbarrierproperties Part6:Odourcontrol AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Aus
18、tria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom.EN137262:2002(E) 4 Introduction EN13726specifiestestmethodsanddoesnotcontainperformancerequirements.Part2ofthisstandard de
19、scribestestmethodsforthedeterminationofthemoisturevapourtransmissionrateofpermeablefilmdressings. TestmethodsforotheraspectsofprimarywounddressingsaredescribedinotherpartsofEN13726.EN137262:2002(E) 5 1Scope Part2ofEN13726describestestmethodsrecommendedfortheevaluationofmoisturevapourtransmissionrate
20、 ofpermeablefilmprimarywounddressings. 2 Termsanddefinitions Forthepurposesofthisstandardthefollowingtermsanddefinitionsapply. 2.1 moisturevapourtransmissionrate(MTVR) permeabilityofmaterialstothepassageofwatermoleculesfromtheskincontactsidetotheexternalatmosphere undercontrolledconditionsofhumidity
21、andtemperature 2.2 permeablewounddressing wounddressingthatpermitswatervapourtopassfromtheskinorwoundthroughittotheexternalatmosphere 2.3 primarywounddressing materialorcombinationofmaterials,inanyshape,formorsizethatisintendedtoremainindirectcontactwitha wound NOTEPrimarywounddressingsareusedasmech
22、anicalbarriers,fortheabsorptionortransmissionofexudates,tomanage themicroenvironmentofthewound,andcanenablethewoundtohealbyprimaryorsecondaryintent.Deviceswhichhavea metabolic,pharmacologicalorimmunologicalinteractionastheirprimaryintentareexcluded. 3 Testmethodsformoisturevapourtransmissionrate(MVT
23、R) 3.1 Testconditions Unlessotherwisestated,conditionthetestsamplesandcarryoutthetestsatatemperatureof(212) Canda relativehumidityof60%RH15%RH. 3.2 MVTRofawounddressingwhenincontactwithwatervapour 3.2.1 Significanceanduse ThetestisintendedfortheevaluationoftheMVTRofawounddressingwhenitisincontactwit
24、hwatervapour. Thistestmeasuresmoisturevapourtransmissionthroughdressingsbymassdifferential.Entrapmentoffluidcan leadtoseriousconsequencesforskinintegrity.Dressingsshouldhavesufficientpermeabilitytomoisturevapourto preventfluidcollectingunderthedressings. NOTEThetestissuitableforusewith,forexample,th
25、infilmwounddressings. 3.2.2Equipment 3.2.2.1 Fiveclean,drycylinders, madeofcorrosionresistantmaterialwithaninternaldiameterof (35,70,1)mm(crosssectionalarea10cm 2 )havingaflangeateachendandableeachtoaccommodate20mlof deionisedwater.(AnexampleofacylinderthathasbeenfoundtobeadequateisgiveninFigure1).
26、Atoneendofthecylinderisanannularclampingplatewithanorificeareaof10cm 2 .Attheotherendofthe cylinderisasolidmetalplatethefulldiameteroftheflange.Asealingringisalsoadvisabletoensureaneffective sealagainsttheflange.Theplatesatbothendsareclampedinpositionagainsttheflanges.EN137262:2002(E) 6 3.2.2.2 Bala
27、nce,capableofweighing100gwithanaccuracyof0,0001g. 3.2.2.3 Humiditymeter ,capableofdetectingwhetherornotthe20%RHlimithasbeenexceeded. 3.2.2.4 Ovenorincubator, havingacirculatingfanandcapableofmaintainingatemperatureof(371)C, andbeingofadesigntodistributetheairevenlythroughouttheovenorincubatorsoastom
28、aintainhumidityatless than20%RHthroughoutthetest. 3.2.2.5 Scalpel,oralternativecuttingequipment. 3.2.3Procedure 3.2.3.1 Usingtheflangeofclampingplateasatemplate,cutoutasampleofthematerialtobetested. 3.2.3.2 Addsufficientdeionisedwateratroomtemperature(minimum20C)toleaveanairgapof(51)mm betweentheliq
29、uidsurfaceandthesamplewhenclampedinplace. 3.2.3.3 Placethecircularsampleexactlyovertheflangeofthetestcontainer.Clampitinplacewithout stretchingthesample,usingtheclampingplate/clampstogiveawatertightseal.Ifthespecimenhasanadhesive coatedsurface,placetheadhesivesidetothecylinderflange.Fornonadhesiveor
30、patterncoatedmaterials,take caretoensureacompleteseal.Repeattheprocedurefourtimessoastopreparefivesamples. NOTEToensureagoodsealasmallamountofsealantsuchaspetrolatumcanbeappliedtotheflange. 3.2.3.4 Weighandrecordthemassofthecontainer,sampleandliquid( W 1 )tothenearest0,0001g. 3.2.3.5 Placethecontain
31、erintheoven/incubatorattemperatureof(371)Cwiththesampleuppermost. 3.2.3.6 After18hto24hremovethecontainerfromtheoven/incubatorandrecordthetestperiod( T)tothe nearest5min. 3.2.3.7 Immediatelyreweighthecontainerandsampleandliquidandrecordthemass( W 2 )tothenearest 0,0001g. 3.2.4 Calculationofresults 3
32、.2.4.1 CalculatetheMTVRusingtheformula: X =( W 1 W 2 ) 1000 24/ T where X isMVTR(g m 2 24h 1 ); W 1 isthemassofthecontainer,sampleandliquid; W 2 isthemassofthecontainer,sampleandliquidaftertestperiod; T isthetestperiodinhours. 3.2.4.2 Calculatethemeanresultofatleastfivesamples. 3.2.4.3 Discardvalues
33、differingbymorethan20%fromthemeanandrepeatthetest. 3.2.4.4 Thetestisinvalidifthehumiditylevelswithintheoven/incubatorrisetomorethan20%RHduring thetestperiod. 3.2.5 Testreport Thereportshallincludeatleastthefollowinginformation:EN137262:2002(E) 7 a) typeofdressing,includinglotnumber; b) anydeviations
34、fromthetestmethod; c) individualandaverageresults; d) dateoftest; e) identityoftheperson(s)whocarriedoutthetest. 3.3 MVTRofawounddressingwhenincontactwithliquid 3.3.1 Significanceanduse ThistestisintendedfortheevaluationoftheMVTRofawaterproofwounddressingwhenitisincontactwithliquid. ItmeasurestheMVT
35、Rthroughdressingsbymassdifferential.Entrapmentofliquidcanleadtoserious consequencesforskinintegrity. 3.3.2Equipment 3.3.2.1 Fiveclean,drycylinders, asspecifiedin3.2.2.1. 3.3.2.2 Balance,asspecifiedin3.2.2.2. 3.3.2.3 Humiditymeter ,asspecifiedin3.2.2.3. 3.3.2.4 Ovenorincubator ,asspecifiedin3.2.2.4.
36、3.3.2.5 Cuttingequipment, asspecifiedin3.2.2.5. 3.3.3Procedure 3.3.3.1 Performtheproceduresdescribedin3.2.3.1to3.2.3.4. 3.3.3.2 Invertthecontainerandplaceitintheoven/incubatorattemperatureof(371) Csothatthe deionisedwaterisincontactwiththesample.Ensurethereisasufficientgapbetweenthesurfaceofthesampl
37、e andthesurfaceoftheoven/incubatorshelftoallowgoodairflowacrossthesurfaceofthesample. 3.3.3.3 Afterapproximately4hremovethecontainerfromtheoven/incubatorandrecordthetestperiod( T) tothenearest5min. 3.3.3.4 Immediatelyreweighthecontainerandsampleandrecordthemass( W 2 )tothenearest0,0001g. 3.3.4 Calcu
38、lationofresults 3.3.4.1 Calculatetheresultsasdescribedin3.2.4.1to3.2.4.4. 3.3.4.2 IftheMVTRofthetestsampleislessthan1000gm 2 24h 1 ,repeatthetestusingatimeof18hto 24hin3.3.3.3. 3.3.5 Testreport Thereportshallincludeatleastthefollowinginformation:EN137262:2002(E) 8 a) typeofdressing,includinglotnumbe
39、r; b) anydeviationsfromthetestmethod; c) individualandaverageresults; d) dateoftest; e) identityoftheperson(s)whocarriedoutthetest.EN137262:2002(E) 9 Dimensionsinmillimetres 55,60,1 32 41 35,70,1 1 A A AA Key 1Sealingring Figure1 ExampleofacylinderthathasbeenfoundtobeadequateBS EN 13726-2:2002 BSI 3
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