{"id":2332,"date":"2024-11-26T10:16:36","date_gmt":"2024-11-26T02:16:36","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2332"},"modified":"2026-02-09T09:59:05","modified_gmt":"2026-02-09T01:59:05","slug":"terms-and-definitions-of-eto-gas-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2332","title":{"rendered":"Terms and definitions of eto gas sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-c4886133 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11-1024x1024.webp\" alt=\"\" class=\"uag-image-8477\" width=\"1024\" height=\"576\" title=\"eto-sterilizer-11\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Vir die doeleindes van hierdie dokument is die volgende terme en definisies van toepassing in <strong>etileenoksied sterilisasie<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/product\/aeration-room\/\">3.1 Belugting <\/a><\/strong><\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-88653b7b wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Aeration-Room-3-300x300.webp\" alt=\"\" class=\"uag-image-8358\" width=\"300\" height=\"300\" title=\"Aeration-Room-3\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">part of the eto gas sterilization process during which ethylene oxide and\/or its<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">reaksieprodukte desorbeer vanaf die mediese toestel totdat voorafbepaalde vlakke bereik word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: This can be performed within the sterilizer and\/or in a separate chamber or room.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.2 belugtingsarea <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">óf &#039;n kamer óf &#039;n kamer waarin belugting plaasvind<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.3 Biolas <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">population of viable microorganisms on or in product and\/or sterile barrier system<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.2]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.4 biologiese aanwyser <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">toetsstelsel wat lewensvatbare mikroörganismes bevat wat &#039;n gedefinieerde weerstand bied teen &#039;n gespesifiseerde eto-gassterilisasieproses<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.5 Kalibrasie <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">stel bewerkings wat, onder gespesifiseerde toestande, die verhouding tussen waardes van &#039;n hoeveelheid wat deur &#039;n meetinstrument of meting aangedui word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">stelsel, of waardes verteenwoordig deur &#039;n wesenlike maatstaf of &#039;n verwysingsmateriaal, en die ooreenstemmende waardes gerealiseer deur standaarde<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.6 chemiese aanwyser <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">toetsstelsel wat &#039;n verandering in een of meer vooraf gedefinieerde prosesveranderlikes openbaar<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">gebaseer op &#039;n chemiese of fisiese verandering as gevolg van blootstelling aan &#039;n proses<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.6]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/product\/precondition-room\/\">3.7 Kondisionering <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">behandeling van produk binne die eto-gassterilisasiesiklus, maar voor etileen<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">oksiedtoelating, om &#039;n voorafbepaalde temperatuur en relatiewe humiditeit te bereik<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Hierdie deel van die etileenoksiedsterilisasiesiklus kan óf by atmosferiese druk óf onder vakuum uitgevoer word.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 2 vir inskrywing: Sien 3.27, voorafkondisionering<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.8 <\/strong><strong><em><strong><em>D <\/em><\/strong><\/em><\/strong><strong>waarde <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>D<\/em>10 <strong>waarde <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">tyd of dosis benodig om inaktivering van 90 % van &#039;n populasie van die toetsmikro-organisme onder genoemde toestande te bereik<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.11] ?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Vir die doeleindes van hierdie Internasionale Standaard, die <em>D <\/em>waarde is die blootstellingstyd wat benodig word om 90 % inaktivering van die populasie van die toetsorganisme te bereik.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.9 Ontwikkeling <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">handeling van die uitbou van &#039;n spesifikasie<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.13]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.10 doupunt <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Die temperatuur waarby die versadigingswaterdampdruk gelyk is aan die<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">gedeeltelike druk van die waterdamp in die atmosfeer<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Enige afkoeling van die atmosfeer onder die doupunt sal waterkondensasie veroorsaak.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.11 Vestig <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">bepaal deur teoretiese evaluering en bevestig deur eksperimentering<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.17]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">9ISO 11135-2014<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/zjbocon.com\/product\/eto-sterilzer\/\"><strong>3.12 etileenoksied (EO) inspuitingstyd<\/strong>&nbsp;<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">duur van die stadium wat begin met die eerste inbring van die EO (mengsel) in die kamer tot die voltooiing van daardie inspuiting<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.13 blootstelling tyd <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">tydperk waarvoor die prosesparameters binne hul gespesifiseerde toleransies gehandhaaf word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.18]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Vir die doel van die berekening van siklusdodelikheid, is dit die tydperk van etileenoksiedsterilisasie tussen die einde van EO-inspuiting en die begin van EO-verwydering.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.14 Fout <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">one or more of the process parameters lying outside of its\/their specified<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">toleransie(s)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.19]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.15 Spoel <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">prosedure waardeur die etileenoksied uit die vrag en kamer verwyder word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">deur óf veelvuldige alternatiewe toelatings van gefiltreerde lug, inerte gas of stoom en ontruiming van die kamer of deurlopende deurgang van gefiltreerde lug, inerte 10ISO 11135-2014 gas of stoom deur die vrag en kamer<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.16 fraksionele siklus <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#039;n siklus waarin die blootstellingstyd aan EO-gas in vergelyking daarmee verminder word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">gespesifiseer in die etileenoksiedsterilisasieproses<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.17 halfsiklus <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#039;n siklus waarin die blootstellingstyd aan EO-gas met 50 % verminder word in vergelyking met die gespesifiseer in die etileenoksiedsterilisasieproses<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.18 gesondheidsorgfasiliteit <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">regerings- en private organisasies en instellings wat aan die<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">bevordering en instandhouding van gesondheid, en die voorkoming en behandeling van<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">siektes en beserings<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">VOORBEELD &#039;n Gesondheidsorgfasiliteit kan &#039;n hospitaal, ouetehuis, uitgebreidesorgfasiliteit, vrystaande chirurgiese sentrum, kliniek, mediese kantoor of tandheelkundige kantoor wees.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.19 gesondheidsorgproduk <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">mediese toestel(le), insluitend <em>in vitro <\/em>diagnostiese mediese toestel(me), of medisinale produk(te), insluitend biofarmaseutiese(s)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">11 ISO 11135-2014<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.20]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">3.20 installasie kwalifikasie <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">proses om bewyse te verkry en te dokumenteer dat toerusting verskaf is<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">en geïnstalleer in ooreenstemming met sy spesifikasie<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.22]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.21 mediese toestel <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">enige instrument, apparaat, implement, masjien, toestel, inplantaat, <em>in vitro <\/em>reagens of kalibreerder, sagteware, materiaal of verwante artikel, wat deur die vervaardiger bedoel is om, alleen of in kombinasie, vir mense vir een of meer van die spesifieke doel(e) van<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 diagnosis, prevention, monitoring, treatment or alleviation of disease,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 investigation, replacement or modification or support of the anatomy or of a physiological process,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 control of conception,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 disinfection of medical devices,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 providing information for medical purposes by means of <em>in vitro <\/em>ondersoek van monsters afkomstig van die menslike liggaam, en wat nie sy vernaamste beoogde werking in of op die menslike liggaam deur farmakologiese, immunologiese of metaboliese middele bereik nie, maar wat deur sodanige middele in sy funksie bygestaan ​​kan word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[BRON: ISO 13485:2003, definisie 3.7]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.22 mikro-organisme <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">entiteit van mikroskopiese grootte, wat bakterieë, swamme, protosoë en virusse insluit<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: &#039;n Spesifieke standaard vereis dalk nie demonstrasie van die<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">doeltreffendheid van die eto gas sterilisasie proses in inaktivering alle vorme van<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">microorganisms, identified in the definition above, for validation and\/or<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">roetine beheer van die eto gas sterilisasie proses.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">3.23 operasionele kwalifikasie <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">proses om bewyse te verkry en te dokumenteer wat toerusting geïnstalleer het<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">werk binne voorafbepaalde perke wanneer dit gebruik word in ooreenstemming met sy<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">operasionele prosedures<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.27]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.24 oormatige benadering<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">benadering deur gebruik te maak van eto-gassterilisasieproses wat &#039;n minimum van 12 Spore Log lewer<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Reduksie (SLR) na &#039;n biologiese aanwyser met &#039;n weerstand gelyk aan of groter as die produk se biolas<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.25 parametriese vrystelling <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">verklaring dat produk steriel is, gebaseer op rekords wat aantoon dat die prosesparameters binne gespesifiseerde toleransies gelewer is<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.29]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Hierdie metode van prosesvrystelling sluit nie die gebruik van biologiese aanwysers in nie.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\">3.26 prestasiekwalifikasie <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">proses van verkryging en dokumentasie van bewyse dat die toerusting, soos geïnstalleer en bedryf in ooreenstemming met operasionele prosedures, konsekwent presteer in ooreenstemming met voorafbepaalde kriteria en daardeur produk lewer wat aan sy spesifikasie voldoen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.30]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-process\/\">3.27 Voorkondisionering <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">behandeling van produk, voor die eto-gassterilisasiesiklus, in &#039;n kamer of kamer om gespesifiseerde toestande vir temperatuur en relatiewe humiditeit te bereik<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.28 proses-uitdagingstoestel <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">item wat ontwerp is om &#039;n gedefinieerde weerstand teen aeto-gassterilisasieproses te vorm en gebruik om prestasie van die proses te assesseer<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.33]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Vir die doel van hierdie Internasionale Standaard kan &#039;n PCD<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">produk, gesimuleerde produk of ander toestel wees wat direk ingeënt is of<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">indirek. Sien 7.1.6 en D.7.1.6.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 2 vir inskrywing: In hierdie Internasionale Standaard word &#039;n onderskeid getref tussen &#039;n interne PCD en &#039;n eksterne PCD. &#039;n Interne PCD word gebruik om te demonstreer dat die vereiste produk SAL bereik word. &#039;n PCD wat binne die grense van die produk- of produkversendinghouer geleë is, is &#039;n interne PCD, terwyl &#039;n PCD geleë tussen versenderhouers of op die buiteoppervlaktes van die vrag &#039;n eksterne PCD is. &#039;n Eksterne PCD is &#039;n item wat ontwerp is om vir mikrobiologiese gebruik te word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">monitering van roetine-produksiesiklusse.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.29 proses parameter <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">gespesifiseerde waarde vir &#039;n proses veranderlike<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Die spesifikasie vir &#039;n eto-gassterilisasieproses sluit die<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">prosesparameters en hul toleransies.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.34]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.30 proses veranderlike <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">toestand binne &#039;n etileenoksiedsterilisasieproses, veranderinge waarin mikrobiese doeltreffendheid verander<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">VOORBEELD?Tyd, temperatuur, druk, konsentrasie, humiditeit, golflengte.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.35]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.31 verwerkingskategorie <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">versameling van verskillende produk- of produkfamilies wat gesteriliseer kan word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">saam<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Alle produkte binne die kategorie is vasbeslote om &#039;n gelyke of mindere uitdaging vir die etileenoksiedsterilisasieproses te bied as die prosesuitdagingstoestel vir daardie groep.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.32 Produk <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">resultaat van &#039;n proses<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[BRON: ISO 9000:2005, definisie 3.4.2]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 by inskrywing: Vir die doeleindes van etileenoksiedsterilisasiestandaarde, is produk<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">tasbaar en kan rou materiaal(e), intermediêre(s), subsamestelling(e) en<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">gesondheidsorg produkte.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.33 produkfamilie <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">groep produkte met eienskappe wat dit moontlik maak om gesteriliseer te word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">deur gebruik te maak van gedefinieerde prosestoestande<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.34 produk laai volume<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">gedefinieerde ruimte binne die bruikbare kamervolume wat deur produk beset word<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.35 erkende kultuurversameling <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">bewaargesag kragtens die Boedapest-verdrag op <em>Die Internasionale<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Erkenning van die Deposito van<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Mikro-organismes vir die doeleindes van patente en regulering<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.38]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.36 verwysingsmikro-organisme <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">mikrobiese stam verkry uit &#039;n erkende kultuurversameling<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.37 Herkwalifikasie <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">herhaling van &#039;n gedeelte van validering met die doel om die voortgesette aanvaarbaarheid van &#039;n gespesifiseerde proses te bevestig<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.38 herbruikbare mediese toestel <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">mediese toestel wat deur die vervaardiger aangewys of bedoel is as geskik vir<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">herverwerking en hergebruik<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Hierdie is nie &#039;n mediese toestel wat aangewys of bedoel is nie<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">deur die vervaardiger slegs vir eenmalige gebruik.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.39 Dienste <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">voorrade van &#039;n eksterne bron, wat nodig is vir die korrekte funksie van toerusting<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">VOORBEELD Elektrisiteit, water, saamgeperste lug, dreinering.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.41]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.40 eenmalige mediese toestel <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">mediese toestel wat deur die vervaardiger aangewys of bedoel is slegs vir eenmalige gebruik<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.41 Spesifiseer <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">in besonderhede in &#039;n goedgekeurde dokument stipuleer<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.42 Spore-log-vermindering <\/strong>log van aanvanklike spoorpopulasie, <em>N<\/em>0, minus die log van die finale bevolking, <em>N<\/em>u<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[BRON: ISO 14161:2009, definisie 3.19]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 by inskrywing: Beskrywing van die vermindering in die aantal spore op a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">biologiese aanwyser of geënte item geproduseer deur blootstelling aan gespesifiseerde<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">voorwaardes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Vir direkte opsomming:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">SLR = log <em>N<\/em>0 log ? <em>N<\/em>u<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">waar<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>0 is die aanvanklike bevolking;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>u is die finale bevolking.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Vir breuk negatief:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">SLR = log <em>N<\/em>0 \u2013 log [ln (<em>q<\/em>\/<em>n<\/em>)]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">waar<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>0 is die aanvanklike bevolking;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>q <\/em>is die aantal replikaatmonsters wat getoets is;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>n <\/em>is die aantal monsters wat negatief is vir groei.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As daar geen oorlewendes is nie, kan die ware SLR nie bereken word nie. Die SLR kan wees<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">reported as \u201cgreater than\u201d log <em>N<\/em>0 as een oorlewende organisme gebruik word.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.43 Steriel <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">vry van lewensvatbare mikroörganismes<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.43]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.44 steriele versperringstelsel<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">minimum pakket wat indringing van mikroörganismes verhoed en asepties toelaat<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">aanbieding van die produk by die gebruikspunt<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.44]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.45 Steriliteit<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">toestand van vry wees van lewensvatbare mikroörganismes<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 by inskrywing: In die praktyk kan geen so &#039;n absolute stelling aangaande die afwesigheid van mikroörganismes bewys word nie.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 2 by inskrywing: Sien 3.47, sterilisasie.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.45]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.46 steriliteitsversekeringsvlak <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">waarskynlikheid van &#039;n enkele lewensvatbare mikro-organisme wat op &#039;n item na<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">sterilisasie<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Die term SAL neem &#039;n kwantitatiewe waarde, gewoonlik 10-6 of 10-3. Wanneer hierdie kwantitatiewe waarde toegepas word op versekering van steriliteit, het &#039;n SAL van 10-6 &#039;n laer waarde, maar bied &#039;n groter versekering van steriliteit as &#039;n SAL van 10-3.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.46]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/product\/eto-sterilzer\/\">3.47 Sterilisasie <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">gevalideerde proses wat gebruik word om produk vry te maak van lewensvatbare mikroörganismes<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 tot inskrywing: In &#039;n sterilisasieproses, die aard van mikrobiese<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">inaktivering is eksponensieel en dus kan die oorlewing van &#039;n mikro-organisme op &#039;n individuele item in terme van waarskynlikheid uitgedruk word. Terwyl hierdie<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">waarskynlikheid kan tot &#039;n baie lae getal verminder word, dit kan nooit tot nul verminder word nie. ISO 11135-2014<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 2 vir inskrywing: Sien 3.46, vlak van steriliteitsversekering.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.47]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-cycle\/\">3.48 sterilisasie siklus <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">treatment in a sealed chamber, which includes air removal, conditioning (if used), injection of ethylene oxide, inert gas (if used), exposure to ethylene oxide, removal of ethylene oxide and flushing (if used), and air\/inert gas admission<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.49 sterilisasie vrag <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">produk wat saam gesteriliseer moet word, of wat saam met &#039;n gegewe gesteriliseer is<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">sterilisasie proses<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.48]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-process\/\">3.50 sterilisasie proses <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">reeks aksies of operasies wat nodig is om die gespesifiseerde vereistes vir steriliteit te bereik<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.49]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Hierdie reeks aksies of bewerkings sluit voorafkondisionering in<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">(indien nodig), blootstelling aan die etileenoksied onder gedefinieerde toestande en enige nodige nabehandeling wat nodig is vir die verwydering van etileenoksied en sy neweprodukte. Dit sluit nie enige skoonmaak-, ontsmettings- of verpakkingshandelinge in wat die sterilisasieproses voorafgaan nie.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.51 sterilisasie spesialis <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">persoon met tegniese kennis van die sterilisasietegnologie wat gebruik word en die uitwerking daarvan op materiale en mikroörganismes<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.52 steriliseermiddel <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">vorming van entiteite wat voldoende mikrobiese aktiwiteit het om steriliteit onder gedefinieerde toestande te bereik<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.50]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.53 oorlewende kurwe <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">grafiese voorstelling van die inaktivering van &#039;n populasie mikroörganismes met toenemende blootstelling aan &#039;n mikrobiese middel onder genoemde toestande<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.51]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.54 toets vir steriliteit <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">tegniese bewerking omskryf in &#039;n farmakopee uitgevoer op produk na blootstelling aan &#039;n sterilisasieproses<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.53]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.55 toets van steriliteit <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">tegniese operasie uitgevoer as deel van ontwikkeling, validering, of<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">herkwalifikasie om die aan- of afwesigheid van lewensvatbare mikroörganismes op produk of gedeeltes daarvan te bepaal<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.54]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3,56 bruikbare kamervolume <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">gedefinieerde ruimte binne die steriliseerderkamer, wat nie deur vaste of mobiele onderdele beperk word nie en wat beskikbaar is om die sterilisasielading te aanvaar<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nota 1 vir inskrywing: Die volume wat toegelaat word vir gassirkulasie rondom die vrag binne<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">die kamer is nie ingesluit as bruikbare spasie nie.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-2\/\">3.57 Bekragtiging <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">gedokumenteerde prosedure vir die verkryging, optekening en interpretasie van die resultate wat vereis word om vas te stel dat &#039;n proses konsekwent produk sal lewer wat aan voorafbepaalde spesifikasies voldoen<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.55]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3,58 maagdelike materiaal <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">materiaal wat nie voorheen gebruik is nie, of aan ander verwerking onderwerp is as vir die oorspronklike produksie daarvan<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">AS JY MEER WIL WEET Oor Etileenoksiedsterilisasie<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefoon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-pos:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Plaaslike terrein: Kamer 1202, Caitong Zhongxin, Xiasha-distrik, Hangzhou-stad, Zhejiang-provinsie, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Webwerf:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">&nbsp;zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vir die doeleindes van hierdie dokument is die volgende terme en definisies van toepassing in etileenoksied sterilisasie 3.1 Belugting deel van [&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":8477,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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