EN 13726-6-2003 en Non-active medical devices - Test methods for primary wound dressing - Part 6 Odour control《非活动医疗设备 原创口敷料试验方法 第6部分 气味控制》.pdf

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1、BRITISH STANDARD BS EN 13726-6:2003 Non-active medical devices Test methods for primary wound dressings Part 6: Odour control The European Standard EN 13726-6:2003 has the status of a British Standard ICS 11.120.20 BS EN 13726-6:2003 This British Standard was published under the authority of the Sta

2、ndards Policy and Strategy Committee on 13 May 2003 BSI 13 May 2003 ISBN 0 580 41798 0 National foreword This British Standard is the official English language version of EN 13726-6:2003. 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 docume

4、nt 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. U

5、sers 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 chan

6、ge, 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 8, an inside back cover and a back cover. The BSI copyright date

7、 displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN137266 April2003 ICS11.120.20 Englishversion NonactivemedicaldevicesTestmethodsforprimarywound dressingPart6:Odourcontro

8、l DispositifsmdicauxnonactifsMthodesdessaipourles pansementsprimairesencontactaveclaplaiePartie6: Contrledelodeur NichtaktiveMedizinproduktePrfverfahrenfrprimre Verbandstoffe(Wundauflagen)Teil6:Geruchsbindung ThisEuropeanStandardwasapprovedbyCENon28February2003. CENmembersareboundtocomplywiththeCEN/

9、CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsin

10、threeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finlan

11、d,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN

12、Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN137266:2003EEN137266:2003(E) 2 Contents page Foreword3 Introduction .4 1 Scope 5 2 Termsanddefinitions. .5 3 Testmethodforodourpenetration. .5 3.1 Significanceanduse .5 3.2 Equipment.5 3.3 Procedure .6 3.4

13、 Results 7 3.5 Testreport . .7EN137266:2003(E) 3 Foreword Thisdocument(EN137266:2003)hasbeenpreparedbyTechnicalCommitteeCEN/TC205,“Nonactivemedical devices“,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorse

14、ment,atthelatestbyOctober2003,andconflictingnationalstandardsshallbewithdrawnatthelatest byOctober2003. EN13726consistsofthefollowingPartsunderthegeneraltitle Nonactivemedicaldevices Testmethodsfor primarywounddressings: Part1:Aspectsofabsorbency Part2:Moisturevapourtransmissionrateofpermeablefilmdr

15、essings Part3:Waterproofness Part4:Conformability Part5:Bacterialbarrierproperties Part6:Odourcontrol AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Ge

16、rmany,Greece,Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal, Slovakia,Spain,Sweden,SwitzerlandandtheUnitedKingdom.EN137266:2003(E) 4 Introduction EN13726givestestmethodsanddoesnotcontainperformancerequirements.EN137266describesatest methodforodourcontrolofprimarywounddres

17、sings. TestmethodsforotheraspectsofprimarywounddressingsaredescribedinotherpartsofEN13726.EN137266:2003(E) 5 1Scope ThisEuropeanStandarddescribesatestmethodfortheevaluationoftheresistanceofprimarywounddressingsto penetrationbyodour. 2 Termsanddefinitions ForthepurposesofthisEuropeanStandard,thefollo

18、wingtermsanddefinitionsapply: 2.1 primarywounddressing materialorcombinationofmaterials,inanyshape,formorsizethatisintendedtoremainindirectcontactwitha wound NOTE Primarywounddressingareusedasmechanicalbarriers,fortheabsorptionortransmissionofexudates,tomanage themicroenvironmentofthewound,andcanena

19、blethewoundtohealbyprimaryorsecondaryintent.Deviceswhichhavea metabolic,pharmacologicalorimmunologicalinteractionastheirprimaryintentareexcluded. 3 Testmethodforodourpenetration 3.1 Significanceanduse Thistestisdesignedtoassesstheresistanceofprimarywounddressingstopenetrationbyodours.Itonlyapplies t

20、odressingsofadesignwheretheodourabsorbingmaterialisnotpenetratedbyexudate. 3.2Equipment 3.2.1 Gaschromatograph(GC),capableoftakingapackedcolumnandrunningunderthefollowingconditions: Injectortemperature :300C; Oventemperature :250C; Detectortemperature :300C; N 2 Flowrate :40ml/min; Detection :FlameI

21、onizationDetectorEN137266:2003(E) 6 3.2.2 PackedGCcolumn,10%OV17(orsimilarthatprovidesnoobstructiontothegaseoussample). 3.2.3 Sealablestainlesssteel(grade316)samplevessel,(ofknownvolume)withsealedinjection/samplingport (seeFigure1). 3.2.4 Suitablegaskets(material:PTFE). 3.2.5 500lgastightsyringe. 3.

22、2.6 Ovencapableofbeingsetat105C. 3.2.7 Ovencapableofbeingsetat37C. 3.2.8 1lsyringe. 3.2.9 Balancereadableto0,001g. 3.3Procedure 3.3.1 ControlPreparation 3.3.1.1 Conditionthesamplevesselforapproximately1hat105Ctoremoveanytracecompounds. 3.3.1.2 Placeagasketbetweenthetwopartsofthevessel. 3.3.1.3 Purge

23、thecompletevesselwithnitrogenthroughtheinjection/samplingportandsealtheportwithan appropriateseptum. 3.3.1.4 Inject0,5lofpure(99,7%)diethylamineintothevesselthroughtheseptum,andplaceintoa37C ovenforapproximately20min. 3.3.1.5 Removea250lsampleofgas,takingcaretopumpthesyringetwicebeforewithdrawingthe

24、plungerto 500lforapproximately10sandreturningtothe250lposition.InjectthissampleslugintotheGC.Repeat gaseoussampleextractiontwice. 3.3.1.6 Usetheaverageofthepeakareasasthecutofflimit. 3.3.2 SamplePreparation 3.3.2.1 Conditionthesamplevesselforapproximately1hat105Ctoremoveanytracecompounds. 3.3.2.2 Ma

25、keupa1,3%w/vsolutionofdiethylamineinwater. 3.3.2.3 Place(20,0+0,5)mlofthesolutionintothelowerpartofthevessel 3.3.2.4 Placeagasketandanappropriatesizeofdressingwiththewoundcontactsidefacingdownoverthe lowerpartofthevessel. 3.3.2.5 Purgethetophalfofthevesselwithnitrogen(20kPa)throughtheinjection/sampl

26、ingport,foratleast 100s.Sealthetophalfinplacewhilstpurging,usingthesecondgasket.Removethepurgelineandsealthe sampleportwithanappropriateseptum. 3.3.2.6 Removeaninitial250lsampleofgas,takingcaretopumpthesyringetwicebeforewithdrawingthe plungerto500lforapproximately10sandreturningtothe250lposition.Inj

27、ectthissampleofgasintotheGC.EN137266:2003(E) 7 3.3.2.7 Placethesamplevesselintoa37Coven,andrepeat3.3.2.6atappropriateintervals,adequateto determinethetimetoachieve6ppmwithanaccuracyof10%,dependingonthesampletype.Repeatuntilthe peakareaofthecontrolisexceeded. 3.4Results Allresultsshallbequotedastimet

28、akenfortheatmosphereinsidetheupperhalfvesseltoreachaconcentrationof 6ppmofdiethylamine. 3.5 Testreport Thereportshallincludeatleastthefollowinginformation: a) typeofdressing,includinglotnumber; b) anydeviationsfromthetestmethod; c) theresultofthetest; d) dateoftest; e) identityoftheperson(s)whocarri

29、edoutthetest.EN137266:2003(E) 8 Dimensionsinmillimetres Key 1Injection/samplingport 2Septum 3Screw cap 4Securing bolts 5Gaskets 6Sample Figure1SealablestainlesssteeltestvesselblankBS EN 13726-6:2003 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent nat

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