BS EN 14079-2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze《非放射性的医疗装置 脱脂纱布 脱脂棉和脱胶纱布的性能.pdf

1、BRITISH STANDARD BS EN 14079:2003 Non-active medical devices Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze The European Standard EN 14079:2003 has the status of a British Standard ICS 11.120.20 BS EN 14079:2003 This British Standard was p

2、ublished under the authority of the Standards Policy and Strategy Committee on 13 May 2003 BSI 13 May 2003 ISBN 0 580 41801 4 National foreword This British Standard is the official English language version of EN 14079:2003. The UK participation in its preparation was entrusted by Technical Committe

3、e CH/205, Non-active medical devices, 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 pu

4、blications referred to in this document 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

5、necessary provisions of a contract. 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

6、interpretation, or proposals for change, 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 18, an inside back cover an

7、d a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN14079 April2003 ICS11.120.20 Englishversion NonactivemedicaldevicesPerformancerequ

8、irementsand testmethodsforabsorbentcottongauzeandabsorbentcotton andviscosegauze DispositifsmdicauxnonactifsExigencesde performanceetmthodesdessaispourlagazedecoton absorbanteetlagazedecotonetviscoseabsorbante NichtaktiveMedizinprodukteLeistungsanforderungenund PrfverfarhenfrVerbandmullausBaumwolleu

9、nd VerbandmullausBaumwolleundViskose ThisEuropeanStandardwasapprovedbyCENon21February2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferenc

10、esconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCent

11、rehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFO

12、RSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN14079:2003EEN14079:2003(E) 2 Contents page Foreword3 Introduction .4 1 Scope

13、5 2 Normativereferences 5 3 Termsanddefinitions. .5 4 Requirements .5 4.1 FibreIdentification .5 4.2 Acidityandalkalinity .5 4.3 Foreignfibres .6 4.4 Fluorescence6 4.5 Threadcount 6 4.6 Masspersquaremetre. .7 4.7 Minimumbreakingload. 7 4.8 Sinkingtime 7 4.9 Ethersolublesubstances .7 4.10 Surfaceacti

14、vesubstances 7 4.11 Watersolublesubstances . .7 4.12 Starchanddextrin . 7 4.13 Extractablecolouringmatter . .7 4.14 Lossondrying . 7 4.15 Sulphatedash .8 5 Testmethods 8 5.1 General8 5.2 Fibreidentification .8 5.3 Testmethodforacidityoralkalinity . .9 5.4 Testmethodforforeignfibres 10 5.5 Testmethod

15、forfluorescence .10 5.6 Testmethodforthreadcount .10 5.7 Testmethodformasspersquaremetre . 10 5.8 Testmethodforminimumbreakingload . .10 5.9 Testmethodforsinkingtime 11 5.10 Testmethodforethersolublesubstances . 11 5.11 Testmethodforsurfaceactivesubstances 11 5.12 Testmethodforwatersolublesubstances

16、. 11 5.13 Testmethodforstarchanddextrin. .11 5.14 Testmethodsforextractablecolouringmatter 12 5.15 Testmethodforlossondrying .12 5.16 Testmethodforsulphatedash .12 6 Testreport . .12 AnnexA (normative) Reagentstodeterminethedegreeofcolorationofliquids13 A.1 Primarysolutions. 13 A.2 Standardsolutions

17、 14 A.3 Referencesolutions. 14 AnnexB (normative) PreparationoftestsolutionS1 7 AnnexZA (informative) ClausesofthisEuropeanStandardaddressingessentialrequirementsorother provisionsofEUDirectives. . 18EN14079:2003(E) 3 Foreword Thisdocument(EN14079:2003)hasbeenpreparedbyTechnicalCommitteeCEN/TC205,“N

18、onactivemedical devices“thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbyOctober2003,andconflictingnationalstandardsshallbewithdrawnatthelatest byOctober2003. Thisdocumenthasbeenpreparedun

19、deramandategiventoCENbytheEuropeanCommissionandtheEuropean FreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). ForrelationshipwithEUDirective(s),seeinformativeannex ZA,whichisanintegralpartofthisdocument. ThisstandardisbasedontheEuropeanPharmacopoeiamonographs.AschargedbyCEN/TC205

20、itisamere reformattingofthemonographs.Itincludesrequirementsandtestmethodsasfarastheyareinlinewiththe essentialrequirementsasdefinedinAnnexIoftheMedicalDeviceDirective93/42/EEC.Thisstandarddoesnot describethefullstateoftheartandthereforewillberevisedimmediatelyafterfinalization. AnnexesAandBarenorma

21、tive. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal, Slovaki

22、a,Spain,Sweden,SwitzerlandandtheUnitedKingdom.EN14079:2003(E) 4 Introduction Absorbentcottongauze,absorbentcottonribbongauzeandabsorbentcottonandviscoseribbongauzewere describedintheEuropeanPharmacopoeia.DuetotheintroductionoftheMedicalDeviceDirective93/42/EEC, thosemonographshavebeenremovedfromtheE

23、uropeanPharmacopoeia.EN14079:2003(E) 5 1Scope Thisstandarddescribestherequirementsandtestmethodsforabsorbentcottongauzeandabsorbentcottonand viscosegauzes.Thestandarddoesnotconsidergauzesimpregnatedwithapharmaceuticalsubstance. 2 Normativereferences Thisstandardcontainsnonormativereferences 3 Termsa

24、nddefinitions ForthepurposesofthisEuropeanStandardthefollowingtermsanddefinitionsapply: 3.1 absorbentcottongauze cottonclothofplainweave,bleachedtoagoodwhiteandpurified,beingwhiteandpracticallyodourless,containing notmorethanslighttracesofleaf,pericapseedcoatorotherimpuritiesandreasonablyfreefromwea

25、vingdefects 3.2 absorbentcottonribbongauze wovenclothsuppliedincontinuousribbonsofvariouswidthswithfastselvedges,madefromcottonthreadsthat arepurified,bleachedandmadeabsorbenteitherbeforeorafterweaving,beingwhiteandpracticallyodourless, containingnotmorethanslighttracesofleaf,pericapseedcoatorotheri

26、mpuritiesandreasonablyfreefrom weavingdefects 3.3 absorbentcottonandviscoseribbongauze wovenclothsuppliedincontinuousribbonsofvariouswidthswithfastselvedges,havinginthewarpcottonthreads andintheweftviscosethreadsorcombinedcottonandviscosethreads,madefromthreadsthatarepurified, bleachedandmadeabsorbe

27、nteitherbeforeorafterweaving,beingwhiteandpracticallyodourless,containingnot morethanslighttracesofleaf,pericarpseedcoatorotherimpuritiesandreasonablyfreefromweavingdefects 4Requirements 4.1Fibre Identification 4.1.1 Absorbentcottongauzeandabsorbentcottonribbongauze Whentestedaccordingto5.2.1thecott

28、onfibresshallconformtotheIDENTtestsA,BandC. 4.1.2 Absorbentcottonandviscoseribbongauze Whentestedaccordingto5.2.2thecottonfibresshallconformtotheIDENTtestsAandCandtheviscosefibres shallconformtoIDENTtestB. Ifitisnecessarytodifferentiatebetweenlustrousormattviscose,theIDENTtestDshallbeused. 4.2 Acidi

29、tyandalkalinity Whentestedaccordingto5.3neithersolutionshallbepink.EN14079:2003(E) 6 4.3Foreign fibres Whentestedaccordingto5.4thecottonandviscosefibresshallconformto5.4,onlyoccasionallyafewisolated foreignfibresbeingallowed. 4.4Fluorescence Whentestedaccordingto5.5thecottonandviscosegauzesshallconf

30、ormto5.5. 4.5Thread count Whentestedaccordingto5.6thethreadcountsper100mmshallbeasgiveninTable1andTable2. Table1Textileandphysicalrequirementsforabsorbentcottongauze Type(number ofthreadsper cm 2 ) Threadsin warpper100 mm Minimum breakingload inNewtonper 50mmwarp way Threadsinweft per100mm Minimum b

31、reaking loadin Newtonper 50mmweft way Minimum massing/m 2 12 734 454 13,0 13light 734 574 14,0 13heavy 704 35 604 20 17,0 17 1005 50 704 30 23,0 18 1005 50 805 30 24,0 20 1206 60 805 35 27,0 22 1206 60 1005 40 30,0 24a 1206 60 1206 50 32,0 24b 1406 70 1006 40 32,0EN14079:2003(E) 7 Table2Textileandph

32、ysicalrequirementsforabsorbentcottonribbongauzeandabsorbentcottonand viscoseribbongauze Type(numberof threadspercm 2 ) Threadsinwarp per100mm Minimumbreaking loadinNewtonper 50mmwarpway Threadsinweftper 100mm Minimummass ing/m 2 22a 1203 a 60 1005 33,5 22b 1203 a 60 1005 44,0 24a 1203 a 60 1206 36,0

33、 aThelimitsareincreasedto4forribbongauze25mmor50mmwideandto8forribbongauze 12,5mmwide. 4.6 Masspersquaremetre Whentestedaccordingto5.7themasspersquaremetreingramsshallbeasgiveninTable1andTable2. 4.7 Minimumbreakingload Whentestedaccordingto5.8theminimumbreakingloadinNewtonper50mmshallbeasgiveninTabl

34、e1and Table2. 4.8Sinking time Whentestedaccordingto5.9thesinkingtimeshallnotexceed10s. 4.9 Ethersolublesubstances Whentestedaccordingto5.10theamountofethersolublesubstancesshallnotbemorethan0,50%. 4.10 Surfaceactivesubstances Whentestedaccordingto5.11thefrothheightabovethesurfaceoftheliquidafter300s

35、shallnotexceed2mm. 4.11 Watersolublesubstances Whentestedaccordingto5.12theamountofwatersolublesubstancesshallnotbemorethan0,50%. 4.12 Starchanddextrin Whentestedaccordingto5.13thesolutionshallnotshowanyblue,violet,reddishorbrownishcolour. 4.13 Extractablecolouringmatter Whentestedaccordingto5.14the

36、liquidobtainedshallnotbemoreintenselycolouredthanreferencesolutionY 5 , GY 6 orareferencesolutionpreparedasfollows:to3,0mlofblueprimarysolutionadd7,0mlofhydrochloricacid (1%m/VHCl)anddilute0,5mlofthissolutionto10,0mlwithhydrochloricacid(1%m/VHCl). NOTE SeeannexAforreferencesolutions. 4.14Lossondryin

37、g Whentestedaccording5.15thelossofmassshallnotbemorethan8,0%.EN14079:2003(E) 8 4.15Sulphatedash Whentestedaccordingto5.16theamountofsulphatedashshallbeasgiveninTable3. Table3Sulphatedashfordifferentmaterials Material Sulphatedash Absorbentcottongauze shallnotexceed0,40% AbsorbentcottongauzeType13lig

38、ht shallnotexceed0,75% Absorbentcottonandmattviscoseribbongauze shallnotexceed1,20% Absorbentcottonandlustrousviscoseribbongauze shallnotexceed0,45% 5Test methods 5.1General Alltestsshallbeperformedwiththematerialinitsfinalformi.e.sterileornonsterile. Allreagentsusedshallbeofanalyticalgrade. NOTE Th

39、epreparationoftestsolutionSisgiveninannexB. 5.2Fibre identification 5.2.1 Absorbentcottongauzeandabsorbentcottonribbongauze 5.2.1.1Reagents a) Zincchloridesolution,iodinated :Dissolve20g0,5gofzincchlorideand6,5g0,1gofpotassiumiodide in10,5ml0,1mlofwater.Add0,5g0,05gofiodineandshakefor15min.Filterifn

40、ecessary.Store protectedfromlight. b) Zincchlorideformicacidsolution :Dissolve20g0,5gofzincchloridein80g1gofan85%m/V solutionofanhydrousformicacid. 5.2.1.2Tests UntwistafewthreadsinthewarpandinthewefttofreeafewofthefibrestobeexaminedandcarryoutIDENT testsA,BandC. IDENTA:Whenexaminedunderamicroscope,

41、thecottonfibreshallbeflat,ribbonlike,10mto40mwide,with thickenedendsandanirregularlyshapedlumen. IDENTB:Whentreatedwithiodinatedzincchloridesolution,thefibresshallbecomeviolet. IDENTC:To0,1g0,05gfibresadd10ml0,1mlofzincchlorideformicacidsolution.Heatto40Candallow tostandfor2,5h,shakingoccasionally.

42、5.2.2 Absorbentcottonandviscoseribbongauze 5.2.2.1Reagent Hydrogenperoxidesolution,dilute :Containsnotlessthan2,5%m/mandnotmorethan3,5%m/mofhydrogen peroxideinwater.EN14079:2003(E) 9 5.2.2.2Tests UntwistafewthreadsinthewarpandinthewefttofreeafewofthefibrestobeexaminedandcarryoutIDENT testsA,BandC.Th

43、efibresfromthewarpshallcomplywithIDENTtestAandC.Thefibresfromtheweftshall complywithIDENTtestBandCandwhereamixtureoffibresispresentsomeofthefibresfromtheweftshall complywithIDENTtestA. IDENTA:Examinedunderamicroscope,eachcottonfibreshallconsistofasinglecell,uptoabout40mmlong andupto40mwide,intheformofaflattenedtubewiththickandroundedwallsandoftentwisted. IDENTB:Theviscosefibresshallhaveanaveragelengthof25mmto50mmandwhenexamin