1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS ISO 8670-3:2000 ICS 11
2、.120.99; 11.180 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Ostomy collection bags Part 3: Determination of odour transmission of colostomy and ileostomy bagsThis British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was
3、 published under the authority of the Standards Committee and comes into effect on 15 April 2000 BSI 04-2000 ISBN 0 580 34641 2 BS ISO 8670-3:2000 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard reproduces verbatim ISO 8670-3:2000 and implements it
4、as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/47, Aids for ostomy and incontinence, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the i
5、nterpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards
6、 which implement international publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purpo
7、rt 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 itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front co
8、ver, the ISO title page, pages ii to iv, pages 1 to 4, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.Referencenumber ISO8670-3:2000(E) INTERNATIONAL STANDARD ISO 8670-3 Firstedition 2000-03-01 Ostomycollectionba
9、gs Part3: Determinationofodourtransmissionof colostomyandileostomybags Poches de recueil pour stomie Partie 3: Dtermination de la fuite dodeur des poches de recueil pour colostomie et ilostomieISO8670-3:2000(E) ii ISO8670-3:2000(E)iii Foreword ISO(theInternationalOrganizationforStandardization)isawo
10、rldwidefederationofnationalstandardsbodies(ISO memberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnical committees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhas therighttoberepresentedonthatcommittee.Internationalorganizations
11、,governmentalandnon-governmental,in liaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnical Commission(IEC)onallmattersofelectrotechnicalstandardization. InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3. DraftInternatio
12、nalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting. PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote. AttentionisdrawntothepossibilitythatsomeoftheelementsofthispartofISO8670maybethesubjectofpatent rights.ISOshallnotbeheldr
13、esponsibleforidentifyinganyorallsuchpatentrights. InternationalStandardISO8670-3waspreparedbyTechnicalCommitteeISO/TC173, Technical systems and aids for disabled or handicapped persons, Subcommittee SC 3, Aids for ostomy and incontinence. ISO8670consistsofthefollowingparts,underthegeneraltitle Ostom
14、y collection bags: Part 1: Vocabulary Part 2: Requirements and test methods Part 3: Determination of odour transmission of colostomy and ileostomy bagsISO8670-3:2000(E) iv Introduction Thistestisdesignedtodeterminetheodourtransmissionofone-pieceandmultiple-pieceostomybagsystems. Goododourbarrierprop
15、ertiesareveryimportantforostomybags.Detectionofoxygentransmissionisusuallyused toassesstheefficacyofbarriermaterialsagainstodourtransmission,butthismeasurementisnotalwayshelpfulin choosingsuitablematerialsforostomybagsbecauseodourbarrierpropertiesarenotalwaysrelatedtooxygen transmission.Theorganolep
16、tictestdescribedhasbeenfoundtodistinguishbetweensystemswhichare consideredtobeodour-proofandthosewhicharenot.Byenclosingthebaginaglassjar,anysignificant transmissionofodourthroughthefilmwillbuildupintoastrongodour.Inthismethod,asinpractice,anyfaint odourswilldissipateandbeunnoticeable.INTERNATIONALS
17、TANDARD ISO8670-3:2000(E)1 Ostomycollectionbags Part3: Determinationofodourtransmissionofcolostomyandileostomy bags 1 Scope ThispartofISO8670specifiesatestmethodforthedeterminationofodourtransmissionofcolostomyand ileostomybags.Thismethodcoversone-pieceandmultiple-piecesystemshavingbothclosed-,andop
18、en-ended bags. 2Termsanddefinitions ForthepurposesofthispartofISO8670,thefollowingtermsanddefinitionsapply. 2.1 ostomybag flexiblecontainerforcollectingbodyeffluentfromastoma ISO8670-1:1988,2.1 2.2 closed-endedbag flexiblecontainer,withoutanopeningfordrainage,forcollectingbodyeffluentfromastoma NOTE
19、 AdaptedfromISO8670-1:1988,2.3. 2.3 open-endedbag flexiblecontainer,withanopeningfordrainage,forcollectingbodyeffluentfromastoma NOTE AdaptedfromISO8670-1:1988,2.4. 2.4 one-pieceostomysystem effluentcollectionsysteminwhichallthecomponentpartsareremovedfromthebodywhenthebagischanged ISO8670-1:1988,2.
20、8 2.5 multiple-pieceflangesystem effluentcollectionsysteminwhichacomponentispositionedaroundthestoma;thiscomponentallowsaneffluent collectionbagtobeattachedorremoved,whileitselfremaininginposition NOTE Thisdefinitionalsoincludestwo-pieceostomysystemISO8670-1:1988,2.9andmultiple-pieceflangesystem ISO
21、8670-2:1996,2.4.ISO8670-3:2000(E) 2 2.6 stoma abnormalopeningestablishedonthebodysurface ISO8670-2:1996,2.10 3Principle Odoriferousmaterial(freshonion)issealedinsideanostomybag.Theostomybagisplacedinasealedjarandthe jarsniffedafterfourhourstodetectwhetherastrongonionodouristransmittedthroughthebag.
22、4 Reagents 4.1 Freshonion(Allium cepa). 4.2 Distilledordeionizedwater. 5 Apparatus 5.1 Glassjar,ofcapacity2,0l 1,0lwithatopopeningof100mm 50mmdiameter,capableofbeingsealed bymeansofaglassormetallid. 5.2 Glassbeakers,ofasuitablesizetofitinsidetheglassjar. 5.3 Waterbathoroven,capableofbeingcontrolleda
23、t34C 1C. 5.4 Stopwatch,orothersimilartimingdevice. 5.5 Stainlesssteelchoppingknifeormechanicalchoppingdevice. NOTE Ablender(mixer)issuitableforthepurposeofthistest. 5.6 Balance,orsimilarweighingdevicewithanaccuracyofatleast 0,1g. 5.7 Equipment,formakingweldedjointsinplasticmaterials. 5.8 Metal,plast
24、icorglassplateforclosingthestomaopeningofthebag.Theplateshallbeatleastasbigasthe adhesiveplateofthebaganditshallbeimpermeabletoonionodour. 5.9 Sealingfilm,takenfromanotherbagofthetypebeingtested. 5.10Double-sidedtape. 6 Detectionofodour Threepersonswithnormalsenseofsmellshallbechosenassnifferstojudg
25、ethepresenceofodourattheendof thetest.ISO8670-3:2000(E)3 7 Procedure 7.1 Ifafilterispresent,sealthefilterfromeithertheoutsideortheinsideasappropriatebymeansofsealingbag filmtakenfromanotherbagofthetypebeingtestedtowhichdouble-sidedtapehasbeenapplied.Thesealingfilm shallbestucksothatthereisatleast10m
26、mwidthofsealaroundthefilter. 7.2 Whentestingopen-endedbags,theopeningofthebagshallbesealedbywelding. 7.3 Whentestingmultiple-pieceproducts,assemblethebagtotheflange. 7.4 Choptheonionsusingtheknifeorthemechanicalchoppingdevicesothatthepiecesarelessthan5mmin size.Place20g 2ginthebagthroughthebagopenin
27、g,ensuringthatnoneoftheonioncomesintocontactwith theoutersurfaceofthebagorwiththeflange. NOTE Onewayofavoidingcontaminationistoweightheoniononasquareofbagfilm,whichisthenfoldedovertomake aparceloftheonion.Theparcelistheninsertedintothebagthroughthebagopeningandtheonionisreleasedintothebag. Thepieceo
28、fusedfilmisleftinthebagduringthetest. Cutonionsshallbewrappedinaluminiumfoilandstoredatroomtemperaturenolongerthan1hbeforethetest. 7.5 Sealthebagopeningbymeansofametal,plasticorglassplate,ensuringthattherearenocreaseswhich couldcreateleaks. 7.6 Add50ml 10mlofwatertothebottomofthejarandplacetheupturn
29、edbeakeronthebottomofthejarto formaplatform.Placethebagontopofthebeakerinsuchawaythatitisnotincontactwiththewater.Sealthejar andplaceitinthewaterbathorovenatatemperatureof34C 1C.Startthestopwatch. NOTE Thepurposeofthewateristocreatehumidityinthejarsimilartothatfoundunderneathclothing.Theodour transm
30、issionpropertiesofsomematerialsareaffectedbyhumidityandtemperature. 7.7 After10minopenthejarandsniffforanyonionodour.Ifodourispresent,andsuspectedtobeduetoa falsepositiveresult,thenrepeatthetest. NOTE Thepurposeofthe10mincheckistoovercomeproblemscausedbycontaminationontheoutsideofthebag.It maywellbe
31、thatthebreakthroughtimeisbelow10minandthatisthereasonfordoingthe10mincheckonceonly. 7.8 Afteraminimumof4handamaximumof4,5hdeterminewhetherastrongodourofonionisdetectableby theproceduregivenin7.9. 7.9 Removetheclosurefromthejarandallowonesniffertosnifftheatmosphereinsidethejar.Closethejar afteramaxim
32、umtimeof5s.Afteraminimumof1min,removetheclosurefromthejarandallowthenextsnifferto sampletheatmosphereinsidethejar.Repeattheprocedureuntileachofthethreesniffershassampledthe atmosphereinsidethejaronce. Odouremanatingfrombagfilmsandadhesivesshallbeignoredandonlytheodourduetoonionshallberecorded. NOTE
33、Thelengthoftimeforwhichthejarisopenediskepttoaminimumtopreventthesmellofoniondecreasing. Itisrecommendedthatanegativecontrolisrunusingabagwithnoonion,asbagfilmsandadhesivesmayhave odoursoftheirown. 7.10Recordtheresultofthesniffingaseither“strongodour“or“noodour“.Ifthethreesniffersarenotinfull agreem
34、ent,amajorityopinionshallbeused. “Amajorityopinion“meansthatiftwooutofthreesniffersfindastrongodour,theresultisreportedas“strong odour“.Ifonlyonesnifferfindsastrongodour,theresultisreportedas“noodour“. Todeterminewhatconstitutesa“strongodour“itisrecommendedthatabagmadefromlow-densitypolyethylene (LD
35、PE)isusedasapositivecontrol.ISO8670-3:2000(E) 4 7.11Washthejarthoroughlyandchangethewaterbeforethenexttest. 8 Testreport Thetestreportshallincludethefollowinginformation: a) referencetothispartofISO8670; b) thedateoftesting; c) theidentityofthebag; d) whetherastrongodourofonionwasdetectableinthejara
36、ttheendofthetestperiodorwhethertherewasno odour; e) anydeviationfromthetestprocedure.BS ISO 8670-3:2000 BSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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