1、BRITISH STANDARD BS EN 13726-4:2003 Non-active medical devices Test methods for primary wound dressings Part 4: Conformability The European Standard EN 13726-4:2003 has the status of a British Standard ICS 11.120.20 BS EN 13726-4:2003 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 41800 6 National foreword This British Standard is the official English language version of EN 13726-4:2003. 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 7 and a back cover. The BSI copyright date displayed in this do
7、cument indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN137264 April2003 ICS11.120.20 Englishversion NonactivemedicaldevicesTestmethodsforprimarywound dressingsPart4:Conformability Dispositifsmdica
8、uxnonactifsMthodesdessaipourles pansementsencontactaveclaplaiePartie4: Conformabilit NichtaktiveMedizinproduktePrfverfarhenfrprimre Verbandstoffe(Wundauflagen)Teil4: Anpassungsfhigkeit ThisEuropeanStandardwasapprovedbyCENon21February2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulatio
9、nswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(En
10、glish,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece,
11、 Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationi
12、nanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN137264:2003EEN137264:2003(E) 2 Contents page Foreword3 Introduction .4 1 Scope 5 2 Termsanddefinitions. .5 3 Testmethodforconformability 5 3.1 Testconditions . .5 3.2 Extensibilityandpermanentset. 5 3.2.1 Significanceanduse .5 3.
13、2.2 Equipment.6 3.2.2.1 Atensiletestingmachinefittedwithaloadcellsuitablefortherangebeingmeasuredcapableof measuringto0,1N. .6 3.2.2.2 Ameansofcuttingaspecimen(25,00,5)mmwide. 6 3.2.2.3 Stopwatch.6 3.2.3 Procedure .6 3.2.3.1 Cutouta(25,00,5)mmwidespecimenrepresentativeofthematerialundertest. .6 3.2.
14、3.2 Afterremovingthespecimenfromtherollorbackingpaper,allowittorelaxforaminimumof 300s.6 3.2.3.3 Place2parallelmarksonthespecimen,(10010)mmapart,suchthatthemarksareatequal distancesfromthetwoends.Measurethedistancebetweenthetwomarkstothenearest0,5 mm (L 1 ).6 3.2.3.4 Clampthespecimenoutsidethemarksi
15、ntothejawsofthetensiletestingmachineandextend thespecimenby20%usinganextensionrateof(30010)mm/min.Recordthemaximumload (ML)tothenearest0,1N. 6 3.2.3.5 Holdthespecimenatthisextensionfor(601)sthenremovethespecimenfromthejawsand allowittorelaxfor(30015)s. .6 3.2.3.6 Remeasurethedistancebetweenthetwomar
16、ksonthespecimen( L 2 ).6 3.2.3.7 Repeat3.2.3.1to3.2.3.6onafurthertwospecimens. 6 3.2.3.8 Repeat3.2.3.1to3.2.3.7withasecondsetofspecimenstakenperpendiculartothefirstset. 6 3.2.4 Calculationofresults 6 3.2.4.1 CalculatetheextensibilityusingFormula1: .6 3.2.4.2 CalculatethepermanentsetusingFormula2: 6
17、3.2.5 Testreport . .7EN137264:2003(E) 3 . Foreword Thisdocument(EN137264:2003)hasbeenpreparedbyTechnicalCommitteeCEN/TC205,“Nonactivemedical devices“,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,at
18、thelatestbyOctober2003,andconflictingnationalstandardsshallbewithdrawnatthelatest byOctober2003. EN13726consistsofthefollowingPartsunderthegeneraltitle Nonactivemedicaldevices Testmethodsfor primarywounddressings: Part1:Aspectsofabsorbency Part2:Moisturevapourtransmissionrateofpermeablefilmdressings
19、 Part3:Waterproofness Part4:Conformability Part5:Bacterialbarrierproperties Part6:Odourcontrol AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundto:Austria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece,Hungary, Iceland,Ireland
20、,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,Switzerland andtheUnitedKingdom.EN137264:2003(E) 4 Introduction EN13726givesatestmethodanddoesnotcontainperformancerequirements.EN137264describestest methodsformeasuringaspectsofconformabilityofprimarywounddressings. Testmetho
21、dsforotheraspectsofprimarywounddressingsaredescribedinotherpartsofEN13726.EN137264:2003(E) 5 1Scope ThisEuropeanStandarddescribesatestmethodformeasuringaspectsofconformabilityofprimarywound dressings. 2 Termsanddefinitions ForthepurposesofthisEuropeanStandardthefollowingtermsanddefinitionsapply: 2.1
22、 primarywounddressing materialorcombinationofmaterials,inanyshape,formorsizethatisintendedtoremainindirectcontactwitha wound NOTE Theyareusedasmechanicalbarriers,fortheabsorptionortransmissionofexudates,tomanagethemicro environmentofthewound,andcanenablethewoundtohealbyprimaryorsecondaryintent.Devic
23、eswhichhaveametabolic, pharmacologicalorimmunologicalinteractionastheirprimaryintentareexcluded 2.2 conformabilityofawounddressing abilitytoadapttotheshapeandmovementofthebody 2.3 extensibility forcerequiredtostretchawounddressingtoknownextension 2.4 permanentset increaseinthelengthofasampleafterstr
24、etchingandrelaxingexpressedasapercentageoftheoriginallength 3 Testmethodforconformability 3.1Test conditions Conditionthesampleforatleast16hat(6015)%RHandatemperatureof(212)Candcarryoutthetestin thesameenvironment. 3.2 Extensibilityandpermanentset 3.2.1 Significanceanduse Thistestisdesignedtoassesst
25、heextensibilityandpermanentsetconformabilityofaprimarywounddressingby measuringitsextensibilityandpermanentset. NOTE1 Whenadressingisappliedinaregionofmovemente.g.overajoint,itisimportantthatitallowssufficientfreedom ofmovementtoavoiddamageunderthedressing.Adressingwhichiseasilyextendedandwhichretur
26、nsclosetoitsoriginal lengthafterextension,willbemorecomfortableforthepatienttowear.Anadhesiveproductwhichextendssufficientlyeasily withtheskin,helpstopreventsubcutaneousshearingdamage. NOTE2 Thetestisparticularlysuitableforadhesivedressingsbutcanalsobeappliedtootherdressingswhicharerequired tomovewi
27、ththeskin.EN137264:2003(E) 6 3.2.2Equipment 3.2.2.1 Atensiletestingmachinefittedwithaloadcellsuitablefortherangebeingmeasuredcapableof measuringto0,1N. 3.2.2.2 Ameansofcuttingaspecimen(25,00,5)mmwide. 3.2.2.3 Stopwatch. 3.2.3Procedure 3.2.3.1 Cutouta(25,00,5)mmwidespecimenrepresentativeofthematerial
28、undertest. 3.2.3.2 Afterremovingthespecimenfromtherollorbackingpaper,allowittorelaxforaminimumof300s. 3.2.3.3 Place2parallelmarksonthespecimen,(10010)mmapart,suchthatthemarksareatequal distancesfromthetwoends.Measurethedistancebetweenthetwomarkstothenearest0,5mm (L 1 ). 3.2.3.4 Clampthespecimenoutsi
29、dethemarksintothejawsofthetensiletestingmachineandextendthe specimenby20%usinganextensionrateof(30010)mm/min.Recordthemaximumload( ML)tothenearest 0,1N. 3.2.3.5 Holdthespecimenatthisextensionfor(601)sthenremovethespecimenfromthejawsandallowit torelaxfor(30015)s. 3.2.3.6 Remeasurethedistancebetweenth
30、etwomarksonthespecimen( L 2 ). 3.2.3.7 Repeat3.2.3.1to3.2.3.6onafurthertwospecimens. 3.2.3.8 Repeat3.2.3.1to3.2.3.7withasecondsetofspecimenstakenperpendiculartothefirstset. 3.2.4 Calculationofresults 3.2.4.1 CalculatetheextensibilityusingFormula1: Extensibility(Ncm 1 )= 5 , 2 ML (1) where ML=maximum
31、load Expresstheresulttothenearest0,1Ncm 1 andcalculatetheaverageresultofeachset. 3.2.4.2 CalculatethepermanentsetusingFormula2: Permanentset(%)= L L L 21 1 100 (2) where L 1 =distancebetweentwomarksbeforeelongation L 2 =distancebetweentwomarksafterelongationEN137264:2003(E) 7 Expresstheresulttothene
32、arest%andcalculatetheaverageresultofeachset. 3.2.5 Testreport Thereportshallincludeatleastthefollowinginformation: a) typeofdressing,includinglotnumber; b) directionofthespecimenstaken; c) anydeviationsfromthetestmethod; d) individualandaverageresults; e) dateoftest; f) identityoftheperson(s)whocarr
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