BS EN 13726-1-2002 Test methods for primary wound dressings - Aspects of absorbency《主要伤口敷料试验方法 吸收度》.pdf

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1、BRITISH STANDARD BS EN 13726-1:2002 Test methods for primary wound dressings Part 1: Aspects of absorbency The European Standard EN 13726-1:2002 has the status of a British Standard ICS 11.120.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13726-1:2002 This British St

2、andard, 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 39510 3 National foreword This British Standard is the o

3、fficial English language version of EN 13726-1:2002. 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 responsibility to: A list of organizations represente

4、d 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 entitled “International Standards Correspondenc

5、e 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 with a British Standard does not of its

6、elf 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 European developments and promulgate the

7、m in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 16, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd.

8、 No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN137261 March2002 ICS11.120.20 Englishversion TestmethodsforprimarywounddressingsPart1:Aspectsof absorbency Mthodesdessaipourlespansementsprimairesen contactaveclaplaiePartie1:Absorption PrfverfahrenfrprimreVerbandstoffe(Wundauflagen)

9、 Teil1:AspektedesSaugverhaltens(Absorption) ThisEuropeanStandardwasapprovedbyCENon25February2002. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalr

10、eferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagem

11、entCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZA

12、TION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN137261:2002EEN137261:2002(E) 2 Contents page Foreword3 Introduction .4 1 Scope 5 2 Termsa

13、nddefinitions. .5 3 Testmethodsforabsorbency. 5 3.1 Testconditions . .5 3.2 Freeswellabsorptivecapacity .5 3.3 Fluidhandlingcapacity(absorbencyplusmoisturevapourtransmissionrate,liquidin contact) .7 3.4 Fluidaffinityofamorphoushydrogeldressings 8 3.5 Gellingcharacteristics . .11 3.6 Dispersioncharac

14、teristics 12 3.7 Dispersion/solubilityofhydrogeldressings. 13EN137261:2002(E) 3 Foreword ThisdocumentEN137261:2002hasbeenpreparedbyTechnicalCommitteeCEN/TC205“Nonactivemedical devices“,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationo

15、fanidenticaltextor byendorsement,atthelatestbySeptember2002,andconflictingnationalstandardsshallbewithdrawnatthe latestbySeptember2002. ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropean FreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). EN137

16、26willconsistofthefollowingpartsunderthegeneraltitleTestmethodsforprimarywounddressings: Part1:Aspectsofabsorbency Part2:Moisturevapourtransmissionrateofpermeablefilmdressings Part3:Waterproofness Part4:Conformability Part5:Bacterialbarrierproperties Part6:Odourcontrol AccordingtotheCEN/CENELECInter

17、nalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom.EN13726

18、1:2002(E) 4 Introduction EN13726specifiestestmethodsanddoesnotcontainperformancerequirements.Part1ofthisstandard describestestmethodsfordifferentaspectsofabsorbency. TestmethodsforotheraspectsofprimarywounddressingsaredescribedinotherpartsofEN13726.EN137261:2002(E) 5 1Scope Part1ofEN13726specifieste

19、stmethodsrecommendedfortheevaluationofsomeaspectsofabsorbencyof primarywounddressings. 2 Termsanddefinitions ForthepurposesofthisEuropeanStandardthefollowingtermsanddefinitionsapply. 2.1 alginatedressing dressingcontainingsaltsofalginicacidswhichinteractwithphysiologicalfluidstoformagel 2.2 amorphou

20、shydrogel semisolidgelthatcontainshydrophilicpolymersandwater 2.3 fluidaffinityofawounddressing abilitytoabsorbfluidfromordonatefluidtoasimulatedwound 2.4 fluidhandlingcapacity sumofthefluidabsorbedandthefluidtranspiredthroughthedressing 2.5 freeswellabsorptivecapacity totalabsorptivecapacityinthepr

21、esenceofexcesstestliquidandintheabsenceofanyappliedload 2.6 primarywounddressing materialorcombinationofmaterials,inanyshape,formorsizethatisintendedtoremainindirectcontactwitha wound NOTEPrimarywounddressingsareusedasmechanicalbarriers,fortheabsorptionortransmissionofexudates,tomanage themicroenvir

22、onmentofthewound,andcanenablethewoundtohealbyprimaryorsecondaryintent.Deviceswhichhavea metabolic,pharmacologicalorimmunologicalinteractionastheirprimaryintentareexcluded. 3 Testmethodsforabsorbency 3.1Test conditions Unlessotherwisestated,conditionthetestsamplesandcarryoutthetestsatatemperatureof(2

23、12)Canda relativehumidityof60%RH15%RH. 3.2 Freeswellabsorptivecapacity 3.2.1 Significanceanduse Thetestisintendedtoassesstheperformanceofdressings,typicallyusedonmoderatelytoheavilyexuding wounds,wheretotalabsorptivecapacityisanimportantfeature. Itisonlyappropriatefordressingswhichwillstayphysically

24、intactandwhichwillreachtheirmaximumabsorptive capacitywithin30min,underthetestconditions.EN137261:2002(E) 6 NOTEThetestissuitableforusewith,forexample,mosttypesofalginatedressingsineitherthesheetorrope(packing)f orm. Inthecaseofalginatedressings,theratiooftestliquidtosampleweightisanimportantfactord

25、uetotheinteractionwhic htakes place. 3.2.2Equipment 3.2.2.1 Petridishes, (905)mmindiameter. 3.2.2.2 Laboratoryoven ,withforcedaircirculation,capableofmaintainingatemperatureof(37 1)C. 3.2.2.3 TestsolutionA , consistingofsodiumchlorideandcalciumchloridesolutioncontaining142mmolof sodiumionsand2,5mmol

26、ofcalciumionsasthechloridesalts.Thissolutionhasanioniccompositioncomparable tohumanserumorwoundexudate.Itispreparedbydissolving8,298gofsodiumchlorideand0,368gofcalcium chloridedihydrateindeionisedwaterandmakingupto1litreinavolumetricflask. 3.2.2.4 Balance,capableofweighing100gwithtothenearest0,0001g

27、. 3.2.3Procedure 3.2.3.1 Placeasingle,weighed5cmx5cm(aspresentedtothewound)or0,2g(forcavitydressing)sample inaPetridish. 3.2.3.2 Addaquantityoftestsolutionwarmedto(37 1)Ccorrespondingto40timesthemassofsample beingexamined, 0,5g. 3.2.3.3 Transfertotheovenandallowtostandfor30minat(37 1)C. 3.2.3.4 Usin

28、gforcepssuspendthesamplebeingexamined,eitherbyonecornerorbyoneendasappropriate, for30sandthenweighit. 3.2.3.5 Repeat3.2.3.1to3.2.3.4withafurtherninesamples 3.2.4 Calculationofresults Expressabsorptivecapacityastheaveragemassofsolutionretainedper100cm 2 (aspresentedtothewound)or pergramofsample(forca

29、vitydressing). 3.2.5 Testreport Thereportshallincludeatleastthefollowinginformation: a) typeofdressing,includinglotnumber; b) anydeviationsfromthetestmethod; c) individualandaverageabsorptivecapacityresults; d) dateoftest; e) identityoftheperson(s)whocarriedoutthetest.EN137261:2002(E) 7 3.3 Fluidhan

30、dlingcapacity(absorbencyplusmoisturevapourtransmissionrate,liquidin contact) 3.3.1 Significanceanduse Thistestisintendedtoassessthefluidhandlingcapacityofwaterproofwounddressingstypicallyusedformore than24handwhenabsorptionofexudateandmanagementofthemicroenvironmentareimportant. 3.3.2Equipment 3.3.2

31、.1 Fiveclean,drycylinders, madeofcorrosionresistantmaterialwithaninternaldiameterof (35,70,1)mm(crosssectionalarea10cm 2 )havingaflangeateachendandableeachtoaccommodate20mlof testsolution.(AnexampleofacylinderthathasbeenfoundtobeadequateisgiveninFigure1). Atoneendofthecylinderisanannularclampingplat

32、ewithanorificeareaof10cm 2 .Topreventtranspiration throughtheedgesofthedressinganimpermeabletapeoralternativesealantmaybeusedinthisarea.Atthe otherendofthecylinderisasolidmetalplatethefulldiameteroftheflange.Asealingringisalsoadvisableto ensureaneffectivesealagainsttheflange.Theplatesatbothendsarecl

33、ampedinpositionagainsttheflanges. 3.3.2.2 TestsolutionA, asspecifiedin3.2.2.3. 3.3.2.3 Acalibratedpipette. 3.3.2.4 Ovenorincubator, havingacirculatingfanandcapableofmaintainingatemperatureof(371)C, andbeingofadesigntodistributetheairevenlythroughouttheovenorincubatorsoastomaintainrelative humidityat

34、lessthan20%RHthroughoutthetest. 3.3.2.5 Humiditymeter ,capableofdetectingwhetherornotthe20%RHlimithasbeenexceeded. 3.3.2.6 Balance,asspecifiedin3.2.2.4. 3.3.3Procedure 3.3.3.1 Cutacircularsampleofdressingsuitabletobeclampedoverthetestapparatustopreventleakage.If appropriate,removethereleaselineranda

35、ffixtotheupperflangeofacylinderwiththewoundcontactsurface facinginwards. 3.3.3.2 Placetheretainingringontheoutersurfaceofthedressingandfasteninplace. 3.3.3.3 Weighthecylindertogetherwiththebaseandclamps( W 1 ).Invertthecylinderand,usingasuitable pipette,addapproximately20mloftestsolutionA.Fixthesoli

36、dplateinpositionandreweigh( W 2 ).Repeatthe procedurefourtimessoastopreparefivesamples. 3.3.3.4 Placetheassembledcylinderintheincubator. 3.3.3.5 After24h,removethecylindersfromtheincubator,allowthemtoequilibrateatroomtemperaturefor 30minandreweigh (W 3 ). 3.3.3.6 Removethesolidplatefromeachcylinder,

37、gentlypouroutanyexcessfluidandleavethecylinderto drainintheinvertedpositionfor(152)min. Reweighthecylinderandallitsassociatedcomponents,includingthedressing (W 4 ). 3.3.3.7 Repeatsteps3.3.3.1to3.3.3.6usingfreshsamplesforacontacttimeof48h. 3.3.4 Calculationofresults 3.3.4.1 Calculatethemassofmoisture

38、vapourlostthroughthedressing (W 2 W 3 )andthemassoffluid absorbedbythematerial (W 4 W 1 )forthe24handthe48hperiods.EN137261:2002(E) 8 3.3.4.2 Recordthevapourlostthroughthedressingandthefluidabsorbedbythedressing.Additionally, recordthesumofthetwomeasurements,whichisthefluidhandlingcapacityofthedress

39、ingat24hand48h. 3.3.4.3 Thetestisinvalidifthehumiditylevelswithintheoven/incubatorrisetomorethan20%RHduring thetestperiod. 3.3.5 Testreport Thereportshallincludeatleastthefollowinginformation: a) typeofdressing,includinglotnumber; b) anydeviationsfromthetestmethod; c) individualandaverageresults; d)

40、 dateoftest; e) identityoftheperson(s)whocarriedoutthetest. 3.4 Fluidaffinityofamorphoushydrogeldressings 3.4.1 Significanceanduse Thistestmethodmeasurestheabilityofhydrogelwounddressingstodonateliquidtoorabsorbliquidfromtest substratesmadefromgelatineoragarrespectively. NOTEThistestmethodissuitable

41、fortheevaluationofthehydroaffinityofamorphoushydrogelwounddressings. 3.4.2Equipment 3.4.2.1 Tensyringes,ofnominalgraduatedcapacity50mlor60 ml,havinganinternaldiameterof (302)mmwiththenozzlescutoff,andalowprofileplunger(seeFigure2). 3.4.2.2 TestsolutionA ,asspecifiedin3.2.2.3. 3.4.2.3 Gelatinpowder,

42、(175bloom) 3.4.2.4 Agarpowder, (bacteriologicalagartype1) 1 3.4.2.5 Selectionofsuitablelaboratoryglassware 3.4.2.6 Balance,capableofweighingupto100,00gtothenearest0,01g 3.4.2.7 Laboratoryautoclave ,suitableforthesterilizationofliquidsinclosedcontainers 3.4.2.8 Impermeablefilmorfoil 3.4.2.9 Laborator

43、yincubator ,capableofmaintainingatemperatureof(252)C 3.4.2.10 Laboratoryincubator ,capableofmaintainingatemperatureof(602)C. 1 BactoagarfromDifcoLaboratoriesisanexampleofasuitableproductavailablecommercially.Thisinformationisgivenfor theconvenienceofusersofthisstandardanddoesnotconstituteanendorsementbyCENoftheproductnamed.EN137261:2002(E) 9 NOTEThesameincubatorcanbeusedfor3.4.2.9and3.4.2.10ifthetestprocedureisarrangedsuchthatbothtemperatures arenotnee