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
