{"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\">Za potrebe ovog dokumenta primjenjuju se sljedeći pojmovi i definicije <strong>sterilizacija etilen oksidom<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/product\/aeration-room\/\">3.1 Prozračivanje <\/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\">produkti reakcije desorbiraju se iz medicinskog proizvoda dok se ne postignu unaprijed određene razine<\/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 područje prozračivanja <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">bilo komora ili prostorija u kojoj dolazi do prozračivanja<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.3 Bioopterećenje <\/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 biološki indikator <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ispitni sustav koji sadrži održive mikroorganizme koji pružaju definiranu otpornost na određeni postupak sterilizacije eto plinom<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.5 Kalibracija <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">skup operacija koje uspostavljaju, pod određenim uvjetima, odnos između vrijednosti veličine prikazane mjernim instrumentom ili mjernim<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">sustava, odnosno vrijednosti predstavljene materijalnom mjerom ili referentnim materijalom, te odgovarajuće vrijednosti ostvarene standardima<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.6 kemijski indikator <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ispitni sustav koji otkriva promjenu u jednoj ili više unaprijed definiranih procesnih varijabli<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">na temelju kemijske ili fizikalne promjene koja je posljedica izlaganja procesu<\/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 Kondicioniranje <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">obrada proizvoda unutar ciklusa sterilizacije eto plinom, ali prije etilena<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">dovod oksida, kako bi se postigla unaprijed određena temperatura i relativna vlažnost<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Ovaj dio ciklusa sterilizacije etilen oksidom može se provesti pri atmosferskom tlaku ili pod vakuumom.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 2 uz unos: Vidi 3.27, predkondicioniranje<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.8 <\/strong><strong><em><strong><em>D <\/em><\/strong><\/em><\/strong><strong>vrijednost <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>D<\/em>10 <strong>vrijednost <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">vrijeme ili doza potrebna za postizanje inaktivacije 90 % populacije ispitivanog mikroorganizma pod navedenim uvjetima<\/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\">Napomena 1 uz unos: Za potrebe ove međunarodne norme, <em>D <\/em>vrijednost je vrijeme izloženosti potrebno za postizanje 90 % inaktivacije populacije ispitivanog organizma.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.9 Razvoj <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">radnja izrade specifikacije<\/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 točka rosišta <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Temperatura pri kojoj je tlak vodene pare zasićenja jednak<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">parcijalni tlak vodene pare u atmosferi<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Svako hlađenje atmosfere ispod točke rosišta dovelo bi do kondenzacije vode.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.11 Uspostaviti <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">odrediti teoretskom procjenom i potvrditi eksperimentom<\/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 vrijeme ubrizgavanja etilen oksida (EO).<\/strong>&nbsp;<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">trajanje faze počevši od prvog unošenja EO (smjese) u komoru do završetka tog ubrizgavanja<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.13 vrijeme izlaganja <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">razdoblje tijekom kojeg se procesni parametri održavaju unutar svojih specificiranih tolerancija<\/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\">Napomena 1 uz unos: U svrhu izračuna smrtnosti ciklusa, to je razdoblje sterilizacije etilen oksidom između kraja ubrizgavanja EO i početka uklanjanja EO.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.14 Kvar <\/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\">tolerancija(e)<\/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 Ispiranje <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">postupak kojim se etilen oksid uklanja iz punjenja i komore<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ili višestrukim naizmjeničnim dopuštanjem filtriranog zraka, inertnog plina ili pare i pražnjenjem komore ili kontinuiranim prolaskom filtriranog zraka, inertnog 10ISO 11135-2014 plina ili pare kroz punjenje i komoru<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.16 frakcijski ciklus <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ciklus u kojem je vrijeme izlaganja plinu EO smanjeno u usporedbi s onim<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">navedeno u postupku sterilizacije etilen oksidom<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.17 poluciklus <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ciklus u kojem je vrijeme izlaganja plinu EO smanjeno za 50 % u usporedbi s onim navedenim u postupku sterilizacije etilen oksidom<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.18 zdravstvena ustanova <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">vladine i privatne organizacije i institucije posvećene<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">promicanje i održavanje zdravlja te prevencija i liječenje<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">bolesti i ozljede<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PRIMJER Zdravstvena ustanova može biti bolnica, starački dom, ustanova za produženu njegu, samostalni kirurški centar, klinika, medicinska ordinacija ili stomatološka ordinacija.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.19 zdravstveni proizvod <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">medicinski uređaj(i), uključujući <em>in vitro <\/em>dijagnostički medicinski uređaj(i) ili medicinski proizvod(e), uključujući biofarmaceutike<\/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 kvalifikacija instalacije <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">postupak dobivanja i dokumentiranja dokaza da je oprema dostavljena<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">i instaliran u skladu sa svojom specifikacijom<\/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 medicinski uređaj <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">bilo koji instrument, aparat, naprava, stroj, uređaj, implantat, <em>in vitro <\/em>reagens ili kalibrator, softver, materijal ili srodni predmet, koje je proizvođač namjeravao koristiti, samostalno ili u kombinaciji, za ljude za jednu ili više specifičnih svrha<\/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>pregled uzoraka izvedenih iz ljudskog tijela, a koji ne postiže svoje glavno namjeravano djelovanje u ili na ljudskom tijelu farmakološkim, imunološkim ili metaboličkim sredstvima, ali može biti potpomognut u svojoj funkciji takvim sredstvima<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[IZVOR: ISO 13485:2003, definicija 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 mikroorganizam <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">entitet mikroskopske veličine, koji obuhvaća bakterije, gljive, protozoe i viruse<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Posebna norma možda neće zahtijevati demonstraciju<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">učinkovitost procesa sterilizacije eto plinom u inaktivaciji svih vrsta<\/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\">rutinska kontrola procesa sterilizacije eto plina.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">3.23 operativna kvalifikacija <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">postupak pribavljanja i dokumentiranja dokaza da je instalirana oprema<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">djeluje unutar unaprijed određenih granica kada se koristi u skladu s njegovim<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">operativne procedure<\/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 pretjerani pristup<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">pristup pomoću procesa sterilizacije eto plinom koji daje najmanje 12 Spore Log<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Redukcija (SLR) na biološki indikator koji ima otpornost jednaku ili veću od biološkog opterećenja proizvoda<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.25 parametarsko otpuštanje <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">izjava da je proizvod sterilan, na temelju zapisa koji pokazuju da su procesni parametri isporučeni unutar navedenih tolerancija<\/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\">Napomena 1 uz unos: Ova metoda procesa oslobađanja ne uključuje upotrebu bioloških indikatora.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\">3.26 kvalifikacija izvedbe <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">postupak dobivanja i dokumentiranja dokaza da oprema, instalirana i korištena u skladu s operativnim postupcima, dosljedno radi u skladu s unaprijed određenim kriterijima i na taj način daje proizvod koji zadovoljava svoje specifikacije<\/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 Predkondicioniranje <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">obrada proizvoda, prije ciklusa sterilizacije eto plinom, u prostoriji ili komori kako bi se postigli određeni uvjeti za temperaturu i relativnu vlažnost<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.28 uređaj za izazivanje procesa <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">predmet dizajniran da predstavlja definiranu otpornost na proces sterilizacije plinom i koristi se za procjenu učinkovitosti procesa<\/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\">Napomena 1 uz unos: U svrhu ove međunarodne norme, PCD može<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">biti proizvod, simulirani proizvod ili drugi uređaj koji je izravno inokuliran ili<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">posredno. Vidi 7.1.6 i D.7.1.6.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 2 uz unos: U ovoj međunarodnoj normi pravi se razlika između unutarnjeg PCD-a i vanjskog PCD-a. Unutarnji PCD koristi se za dokazivanje da je postignut traženi SAL proizvoda. PCD koji se nalazi unutar granica proizvoda ili kutije pošiljatelja proizvoda je unutarnji PCD, dok je PCD smješten između kutija pošiljatelja ili na vanjskim površinama tereta vanjski PCD. Vanjski PCD je predmet dizajniran da se koristi za mikrobiološke<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">praćenje rutinskih proizvodnih ciklusa.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.29 parametar procesa <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">specificirana vrijednost za procesnu varijablu<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Specifikacija za postupak sterilizacije eto plinom uključuje<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">procesne parametre i njihove tolerancije.<\/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 varijabla procesa <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">stanje unutar procesa sterilizacije etilen oksidom, čije promjene mijenjaju mikrobicidnu učinkovitost<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PRIMJER? Vrijeme, temperatura, tlak, koncentracija, vlažnost, valna duljina.<\/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 kategorija obrade <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">zbirka različitih proizvoda ili obitelji proizvoda koji se mogu sterilizirati<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">zajedno<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Utvrđeno je da svi proizvodi unutar kategorije predstavljaju jednak ili manji izazov za postupak sterilizacije etilen oksidom od uređaja za izazov procesa za tu skupinu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.32 Proizvod <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">rezultat procesa<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[IZVOR: ISO 9000:2005, definicija 3.4.2]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Za potrebe standarda sterilizacije etilen oksidom, proizvod je<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">opipljivi i mogu biti sirovina(e), intermedijer(i), podsklop(ovi) i<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">proizvodi za njegu zdravlja.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.33 obitelj proizvoda <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">skupinu proizvoda koji posjeduju svojstva koja im omogućuju sterilizaciju<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">koristeći definirane procesne uvjete<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.34 volumen punjenja proizvoda<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">definirani prostor unutar korisnog volumena komore koji zauzima proizvod<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.35 priznata zbirka kulture <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">depozitarno tijelo prema Budimpeštanskom ugovoru o <em>Internacionala<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Priznavanje depozita<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Mikroorganizmi za potrebe patenata i propisa<\/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 referentni mikroorganizam <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">soj mikroba dobiven iz priznate zbirke kultura<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.37 Prekvalifikacija <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ponavljanje dijela validacije u svrhu potvrđivanja kontinuirane prihvatljivosti određenog procesa<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.38 višekratni medicinski uređaj <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">medicinski proizvod koji je proizvođač odredio ili odredio kao prikladan za<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ponovna obrada i ponovna uporaba<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Ovo nije medicinski proizvod koji je naznačen ili namijenjen<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">od strane proizvođača samo za jednokratnu upotrebu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.39 Usluge <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">opskrba iz vanjskog izvora, potrebna za ispravan rad opreme<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PRIMJER Struja, voda, komprimirani zrak, odvodnja.<\/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 medicinski proizvod za jednokratnu upotrebu <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">medicinski proizvod koji je proizvođač odredio ili namjenio samo za jednokratnu uporabu<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.41 Navedite <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">detaljno odrediti u odobrenom dokumentu<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.42 Spore-log-redukcija <\/strong>dnevnik početne populacije spora, <em>N<\/em>0, minus log konačne populacije, <em>N<\/em>u<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[IZVOR: ISO 14161:2009, definicija 3.19]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Opisivanje smanjenja broja spora na a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">biološki indikator ili inokulirani predmet proizveden izlaganjem navedenoj<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">uvjetima.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Za izravno nabrajanje:<\/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\">gdje<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>0 je početna populacija;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>u je konačna populacija.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Za negativan razlomak:<\/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\">gdje<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>0 je početna populacija;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>q <\/em>je broj testiranih ponovljenih uzoraka;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>n <\/em>je broj uzoraka negativnih na rast.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ako nema preživjelih, pravi SLR se ne može izračunati. SLR može biti<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">reported as \u201cgreater than\u201d log <em>N<\/em>0 ako se koristi jedan preživjeli organizam.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.43 Sterilno <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">bez mikroorganizama sposobnih za život<\/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 sustav sterilne barijere<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">minimalno pakiranje koje sprječava ulazak mikroorganizama i omogućuje aseptiku<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">prezentacija proizvoda na mjestu uporabe<\/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 Sterilnost<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">stanje u kojem nema živih mikroorganizama<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: U praksi se ne može dokazati takva apsolutna izjava o odsutnosti mikroorganizama.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 2 uz unos: Vidi 3.47, sterilizacija.<\/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 razina osiguranja sterilnosti <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">vjerojatnost pojave jednog održivog mikroorganizma na predmetu nakon<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">sterilizacija<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Izraz SAL ima kvantitativnu vrijednost, općenito 10-6 ili 10-3. Kada se ova kvantitativna vrijednost primjenjuje na osiguranje sterilnosti, SAL od 10-6 ima nižu vrijednost, ali daje veće osiguranje sterilnosti od SAL-a od 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 Sterilizacija <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">validirani postupak koji se koristi za oslobađanje proizvoda od živih mikroorganizama<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: U procesu sterilizacije, priroda mikroba<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">inaktivacija je eksponencijalna i stoga se preživljavanje mikroorganizma na pojedinom predmetu može izraziti kao vjerojatnost. Dok ovo<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">vjerojatnost se može svesti na vrlo mali broj, nikad se ne može svesti na nulu. ISO 11135-2014<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 2 uz unos: Vidi 3.46, razina osiguranja sterilnosti.<\/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 ciklus sterilizacije <\/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 sterilizacijsko opterećenje <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">proizvod koji treba ili je steriliziran zajedno korištenjem danog<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">proces sterilizacije<\/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 postupak sterilizacije <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">niz radnji ili operacija potrebnih za postizanje specificiranih zahtjeva za sterilnost<\/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\">Napomena 1 uz unos: Ovaj niz akcija ili operacija uključuje predkondicioniranje<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">(ako je potrebno), izlaganje etilen oksidu pod definiranim uvjetima i bilo koja potrebna naknadna obrada potrebna za uklanjanje etilen oksida i njegovih nusproizvoda. Ne uključuje nikakve postupke čišćenja, dezinfekcije ili pakiranja koji prethode postupku sterilizacije.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.51 specijalist za sterilizaciju <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">osoba s tehničkim znanjem o tehnologiji sterilizacije koja se koristi i njezinim učincima na materijale i mikroorganizme<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.52 sredstvo za sterilizaciju <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">inacija entiteta koji imaju dovoljno mikrobicidnog djelovanja za postizanje sterilnosti pod definiranim uvjetima<\/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 krivulja preživjelih <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">grafički prikaz inaktivacije populacije mikroorganizama s povećanjem izloženosti mikrobicidnom sredstvu u navedenim uvjetima<\/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 ispitivanje sterilnosti <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">tehnički postupak definiran u farmakopeji koji se izvodi na proizvodu nakon izlaganja postupku sterilizacije<\/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 test sterilnosti <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">tehnička operacija koja se izvodi kao dio razvoja, validacije ili<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ponovna kvalifikacija za utvrđivanje prisutnosti ili odsutnosti živih mikroorganizama na proizvodu ili njegovim dijelovima<\/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 korisni volumen komore <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">definiran prostor unutar komore sterilizatora, koji nije ograničen fiksnim ili pokretnim dijelovima i koji je dostupan za prihvaćanje sterilizacijskog tereta<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Napomena 1 uz unos: Volumen dopušten za cirkulaciju plina oko tereta unutar<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">komora nije uključena kao korisni prostor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-2\/\">3.57 Validacija <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">dokumentirani postupak za dobivanje, bilježenje i tumačenje rezultata potrebnih za utvrđivanje da će proces dosljedno dati proizvod koji je u skladu s unaprijed određenim specifikacijama<\/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 djevičanski materijal <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">materijal koji prethodno nije bio korišten ili podvrgnut obradi koja nije drugačija od izvorne proizvodnje<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">AKO ŽELITE ZNATI VIŠE o sterilizaciji etilen oksidom<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Lokalno mjesto: soba 1202, Caitong Zhongxin, okrug Xiasha, grad Hangzhou, provincija Zhejiang, Kina<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Web stranica:<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>Za potrebe ovog dokumenta, sljedeći pojmovi i definicije primjenjuju se na sterilizaciju etilen oksidom 3.1 Prozračivanje dijela [&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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sterilization goods, follow the closing procedure for the discharge door, and inflate the sealing gasket of the discharge door until the pressure reaches above 0.45 MPa to ensure a proper seal. 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