BS EN 13726-2-2002 Test methods for primary wound dressings - Moisture vapour transmission rate of permeable film dressings《主要伤口敷料试验方法 可渗透薄膜敷料湿气蒸发传输率》.pdf

上传人:twoload295 文档编号:571791 上传时间:2018-12-13 格式:PDF 页数:12 大小:146.41KB
下载 相关 举报
BS EN 13726-2-2002 Test methods for primary wound dressings - Moisture vapour transmission rate of permeable film dressings《主要伤口敷料试验方法 可渗透薄膜敷料湿气蒸发传输率》.pdf_第1页
第1页 / 共12页
BS EN 13726-2-2002 Test methods for primary wound dressings - Moisture vapour transmission rate of permeable film dressings《主要伤口敷料试验方法 可渗透薄膜敷料湿气蒸发传输率》.pdf_第2页
第2页 / 共12页
BS EN 13726-2-2002 Test methods for primary wound dressings - Moisture vapour transmission rate of permeable film dressings《主要伤口敷料试验方法 可渗透薄膜敷料湿气蒸发传输率》.pdf_第3页
第3页 / 共12页
BS EN 13726-2-2002 Test methods for primary wound dressings - Moisture vapour transmission rate of permeable film dressings《主要伤口敷料试验方法 可渗透薄膜敷料湿气蒸发传输率》.pdf_第4页
第4页 / 共12页
BS EN 13726-2-2002 Test methods for primary wound dressings - Moisture vapour transmission rate of permeable film dressings《主要伤口敷料试验方法 可渗透薄膜敷料湿气蒸发传输率》.pdf_第5页
第5页 / 共12页
点击查看更多>>
资源描述

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

40、89 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are

41、updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this Bri

42、tish Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel: +44 (0)20 8996 9000. Fax: +44 (0)20 8996 7400. BSI offers members an individual updating service called PLUS which ensures that subscribers automaticall

43、y receive the latest editions of standards. Buying standards Orders for all BSI, international and foreign standards publications should be addressed to Customer Services. Tel: +44 (0)20 8996 9001. Fax: +44 (0)20 8996 7001. Email: ordersbsi-. Standards are also available from the BSI website at http

44、:/www.bsi-. In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as British Standards, unless otherwise requested. Information on standards BSI provides a wide range of information on national, European and internation

45、al standards through its Library and its Technical Help to Exporters Service. Various BSI electronic information services are also available which give details on all its products and services. Contact the Information Centre. Tel: +44 (0)20 8996 7111. Fax: +44 (0)20 8996 7048. Email: infobsi-. Subscrib

展开阅读全文
相关资源
  • BS ISO IEC 29150-2011 Information technology Security techniques Signcryption《信息技术 安全技术 签密》.pdfBS ISO IEC 29150-2011 Information technology Security techniques Signcryption《信息技术 安全技术 签密》.pdf
  • BS ISO IEC 15408-1-2009 Information technology - Security techniques - Evaluation criteria for IT Security - Introduction and general model《信息技术 安全技术 IT安全评价准则 一.pdfBS ISO IEC 15408-1-2009 Information technology - Security techniques - Evaluation criteria for IT Security - Introduction and general model《信息技术 安全技术 IT安全评价准则 一.pdf
  • BS ISO 7295-1988+A1-2014 Tyre valves for aircraft Interchangeability dimensions《飞机轮胎汽门嘴 互换性尺寸》.pdfBS ISO 7295-1988+A1-2014 Tyre valves for aircraft Interchangeability dimensions《飞机轮胎汽门嘴 互换性尺寸》.pdf
  • BS ISO 15118-1-2013 Road vehicles Vehicle to grid communication interface General information and use-case definition《道路车辆 车辆到电力通讯接口 通用信息和使用案例定义》.pdfBS ISO 15118-1-2013 Road vehicles Vehicle to grid communication interface General information and use-case definition《道路车辆 车辆到电力通讯接口 通用信息和使用案例定义》.pdf
  • BS ISO 13765-2-2004 Refractory mortars - Determination of consistency using the reciprocating flow table method《耐熔灰浆 使用往复流动表法测定一致性》.pdfBS ISO 13765-2-2004 Refractory mortars - Determination of consistency using the reciprocating flow table method《耐熔灰浆 使用往复流动表法测定一致性》.pdf
  • BS ISO 10998-2008+A1-2014 Agricultural tractors Requirements for steering《农业拖拉机 操纵要求》.pdfBS ISO 10998-2008+A1-2014 Agricultural tractors Requirements for steering《农业拖拉机 操纵要求》.pdf
  • BS Z 9-1998 Space data and information transfer systems - Advanced orbiting systems - Networks and data links - Architectural specification《空间数据和信息传输系统 高级轨道系统 网络和数据链接 结构规范》.pdfBS Z 9-1998 Space data and information transfer systems - Advanced orbiting systems - Networks and data links - Architectural specification《空间数据和信息传输系统 高级轨道系统 网络和数据链接 结构规范》.pdf
  • BS Z 7-1998 Space data and information transfer systems - ASCII encoded English《空间数据和信息传输系统 ASCII 编码英语》.pdfBS Z 7-1998 Space data and information transfer systems - ASCII encoded English《空间数据和信息传输系统 ASCII 编码英语》.pdf
  • BS Z 5-1997 Space data and information transfer systems - Standard formatted data units - Control authority procedures《航天数据和信息发送系统 标准格式数据单元 控制授权程序》.pdfBS Z 5-1997 Space data and information transfer systems - Standard formatted data units - Control authority procedures《航天数据和信息发送系统 标准格式数据单元 控制授权程序》.pdf
  • BS Z 4-1997 Space data and information transfer systems - Standard formatted data units - Structure and construction rules《航天数据和信息传输系统 标准格式数据单元 结构和构造规则》.pdfBS Z 4-1997 Space data and information transfer systems - Standard formatted data units - Structure and construction rules《航天数据和信息传输系统 标准格式数据单元 结构和构造规则》.pdf
  • 猜你喜欢
    相关搜索

    当前位置:首页 > 标准规范 > 国际标准 > BS

    copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
    备案/许可证编号:苏ICP备17064731号-1