{"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\/terms-and-definitions-of-eto-gas-sterilization\/","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\">For the purposes of this document, the following terms and definitions apply in <strong>ukukhishwa kwe-ethylene oxide<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/product\/aeration-room\/\">3.1 Aeration <\/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\">reaction products desorb from the medical device until predetermined levels are reached &nbsp;<\/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 aeration area <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">either a chamber or a room in which aeration occurs<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.3 Bioburden <\/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 biological indicator <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">test system containing viable microorganisms providing a defined resistance to a specified eto gas sterilization process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.5 Calibration <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">system, or values represented by a material measure or a reference material, and the corresponding values realized by standards<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.6 chemical indicator <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">test system that reveals a change in one or more pre-defined process variables<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">based on a chemical or physical change resulting from exposure to a process<\/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 Conditioning <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">treatment of product within the eto gas sterilizationtion cycle, but prior to ethylene<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">oxide admission, to attain a predetermined temperature and relative humidity<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: This part of the ethylene oxide sterilization cycle can be carried out either at atmospheric pressure or under vacuum.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 2 to entry: See 3.27, preconditioning<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.8 <\/strong><strong><em><strong><em>D <\/em><\/strong><\/em><\/strong><strong>value <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>D<\/em>Okuthenyalwayo <strong>value <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">time or dose required to achieve inactivation of 90 % of a population of the test microorganism under stated conditions<\/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\">Note 1 to entry: For the purposes of this International Standard, the <em>D <\/em>value is the exposure time required to achieve 90 % inactivation of the population of the test organism.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.9 Development <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">act of elaborating a specification<\/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 dew point <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The temperature at which the saturation water vapour pressure is equal to the<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">partial pressure of the water vapour in the atmosphere<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: Any cooling of the atmosphere below the dew point would produce water condensation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.11 Establish <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">determine by theoretical evaluation and confirm by experimentation<\/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 ethylene oxide (EO) injection time<\/strong>&nbsp;<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">duration of the stage beginning with the first introduction of the EO (mixture) into the chamber to the completion of that injection<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.13 exposure time <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">period for which the process parameters are maintained within their specified tolerances<\/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\">Note 1 to entry: For the purpose of calculation of cycle lethality, it is the period of ethylene oxide sterilization between the end of EO injection and the beginning of EO removal.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.14 Fault <\/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\">tolerance(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 Flushing <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">procedure by which the ethylene oxide is removed from the load and chamber<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">by either multiple alternate admissions of filtered air, inert gas or steam and evacuations of the chamber or continuous passage of filtered air, inert 10ISO 11135-2014 &nbsp;gas or steam through the load and chamber<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.16 fractional cycle <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a cycle in which the exposure time to EO gas is reduced compared to that<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">specified in the ethylene oxide sterilization process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.17 half cycle <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a cycle in which the exposure time to EO gas is reduced by 50 % compared to that specified in the ethylene oxide sterilization process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.18 health care facility <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">izinhlangano zikahulumeni nezizimele kanye nezikhungo ezizinikele ku<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ukugqugquzelwa nokugcinwa kwezempilo, kanye nokuvinjelwa nokwelashwa<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">izifo nokulimala<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ISIBONELO Isikhungo sokunakekelwa kwezempilo kungaba yisibhedlela, ikhaya labahlengikazi, indawo yokunakekela enwetshiwe, isikhungo sokuhlinza samahhala, umtholampilo, ihhovisi lezokwelapha, noma ihhovisi lamazinyo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.19 umkhiqizo wokunakekelwa kwezempilo <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">i(izi)setshenziswa zokwelapha, okuhlanganisa <em>ku-vitro <\/em>idivayisi(s) yezokwelapha ezixilongayo, noma imikhiqizo yokwelapha, kuhlanganisa ne(s) biopharmaceutical<\/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 ukufakwa iziqu <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">inqubo yokuthola kanye nokubhala ubufakazi bokuthi okokusebenza kuhlinzekiwe<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">futhi ifakwe ngokuhambisana nokucaciswa kwayo<\/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 idivayisi yezokwelapha <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">noma iyiphi insimbi, okokusebenza, okokusebenza, umshini, into esetshenziswayo, into efakwayo, <em>ku-vitro <\/em>i-reagent noma i-calibrator, isofthiwe, impahla noma i-athikili ehlobene, ehloselwe umenzi ukuthi isetshenziswe, yedwa noma inhlanganisela, kubantu ngenjongo eyodwa noma ngaphezulu<\/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>ku-vitro <\/em>examination of specimens derived from the human body, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO 13485:2003, definition 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 microorganism <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: A specific standard might not require demonstration of the<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">effectiveness of the eto gas sterilization process in inactivating all types of<\/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\">routine control of the eto gas sterilization process.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">3.23 operational qualification <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">process of obtaining and documenting evidence that installed equipment<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">operates within predetermined limits when used in accordance with its<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">operational procedures<\/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 overkill approach<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">approach using eto gas sterilization process that delivers a minimum of 12 Spore Log<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Reduction (SLR) to a biological indicator having a resistance equal to or greater than the product bioburden<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.25 parametric release <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">declaration that product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances<\/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\">Note 1 to entry: This method of process release does not include the use of biological indicators.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\">3.26 performance qualification <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">inqubo yokuthola kanye nokubhala ubufakazi bokuthi okokusebenza, njengoba kufakiwe futhi kusetshenziswa ngokuhambisana nezinqubo zokusebenza, kusebenza ngokungaguquguquki ngokuya ngemibandela enqunywe kusengaphambili futhi ngaleyo ndlela kukhiqize umkhiqizo uhlangabezana nencazelo yawo.<\/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 Imibandela yangaphambili <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ukwelashwa komkhiqizo, ngaphambi komjikelezo wokuvala inzalo yegesi ye-eto, ekamelweni noma ekamelweni ukuze kutholwe izimo ezithile zokushisa nomswakama ohlobene<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.28 inqubo inselele idivayisi <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">into edizayinelwe ukuhlanganisa ukumelana okuchaziwe kunqubo yokuvala inzalo yegesi ye-aeto futhi isetshenziselwe ukuhlola ukusebenza kwenqubo.<\/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\">Qaphela 1 kokufakwayo: Ngenhloso yaleli Zinga lamazwe ngamazwe, i-PCD ingakwazi<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">kube umkhiqizo, umkhiqizo ofanisiwe noma esinye isisetshenziswa esigonyelwe ngqo noma<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ngokungaqondile. Bheka u-7.1.6 kanye no-D.7.1.6.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Qaphela 2 kokufakwayo: Kuleli Zinga lamazwe ngamazwe, kwenziwa umehluko phakathi kwe-PCD yangaphakathi ne-PCD yangaphandle. I-PCD yangaphakathi isetshenziselwa ukukhombisa ukuthi umkhiqizo odingekayo we-SAL uyazuzwa. I-PCD etholakala ngaphakathi kwemikhawulo yomkhiqizo noma ikesi lomthumeli womkhiqizo i-PCD yangaphakathi, kuyilapho i-PCD etholakala phakathi kwamakesi omthumeli noma ngaphandle komthwalo i-PCD yangaphandle. I-PCD yangaphandle iyinto eklanyelwe ukusetshenziselwa i-microbiological<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ukuqapha imijikelezo yokukhiqiza ejwayelekile.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.29 ipharamitha yenqubo <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">inani elishiwo lokuguquguquka kwenqubo<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Inothi 1 elizofakwa: Incazelo yenqubo yokuvala inzalo yegesi ye-eto ifaka phakathi<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">process parameters and their tolerances.<\/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 process variable <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">condition within a ethylene oxide sterilization  process, changes in which alter microbicidal effectiveness<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EXAMPLE?Time, temperature, pressure, concentration, humidity, wavelength.<\/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 processing category <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">collection of different product or product families that can be sterilized<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">together<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: All products within the category have been determined to present an equal or lesser challenge to the ethylene oxide sterilization process than the process challenge device for that group.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.32 Product <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">result of a process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO 9000:2005, definition 3.4.2]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: For the purposes of ethylene oxide sterilization standards, product is<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">tangible and can be raw material(s), intermediate(s), sub-assembly(ies) and<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">health care products.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.33 product family <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">group of product possessing characteristics that allow them to be sterilized<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">using defined process conditions<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.34 product load volume<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">defined space within the usable chamber volume occupied by product<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.35 recognized culture collection <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">depository authority under the Budapest Treaty on <em>The International<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Recognition of the Deposit of<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Microorganisms for the Purposes of Patent and Regulation<\/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 reference microorganism <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">microbial strain obtained from a recognized culture collection<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.37 Requalification <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">repetition of part of validation for the purpose of confirming the continued acceptability of a specified process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.38 reusable medical device <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">medical device designated or intended by the manufacturer as suitable for<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">reprocessing and re-use<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: This is not a medical device that is designated or intended<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">by the manufacturer for single use only.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.39 Services <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">supplies from an external source, needed for the correct function of equipment<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EXAMPLE Electricity, water, compressed air, drainage.<\/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 single-use medical device <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">medical device designated or intended by the manufacturer for one-time use only<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.41 Specify <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">stipulate in detail within an approved document<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.42 Spore-log-reduction <\/strong>log of initial spore population, <em>N<\/em>0, minus the log of the final population, <em>N<\/em>u<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO 14161:2009, definition 3.19]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: Describing the reduction in the number of spores on a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">biological indicator or inoculated item produced by exposure to specified<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">conditions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For Direct Enumeration:<\/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\">where<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>0 is the initial population;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>u is the final population.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For Fraction Negative:<\/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\">where<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>0 is the initial population;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>q <\/em>is the number of replicate samples tested;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>n <\/em>is the number of samples negative for growth.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If there are no survivors, the true SLR cannot be calculated. The SLR can be<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">reported as \u201cgreater than\u201d log <em>N<\/em>0 if one surviving organism is used.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.43 Sterile <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">free from viable microorganisms<\/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 sterile barrier system<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">minimum package that prevents ingress of microorganisms and allows aseptic<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">presentation of the product at the point of use<\/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 Sterility<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">state of being free from viable microorganisms<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 2 to entry: See 3.47, sterilization.<\/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 sterility assurance level <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">probability of a single viable microorganism occurring on an item after<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">sterilization<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: The term SAL takes a quantitative value, generally 10-6&nbsp;or 10-3. When applying this quantitative value to assurance of sterility, an SAL of 10-6&nbsp;has a lower value but provides a greater assurance of sterility than an SAL of 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 Sterilization <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">validated process used to render product free from viable microorganisms<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: In a sterilization process, the nature of microbial<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">inactivation is exponential and thus the survival of a microorganism on an individual item can be expressed in terms of probability. While this<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">probability can be reduced to a very low number, it can never be reduced to zero. ISO 11135-2014<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 2 to entry: See 3.46, sterility assurance level.<\/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 umjikelezo wokuvala inzalo <\/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 umthwalo wokuvala inzalo <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">umkhiqizo ozoba, noma oseke wafakwa inzalo ndawonye kusetshenziswa into ethile<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">inqubo yokuvala inzalo<\/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 inqubo yokuvala inzalo <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">uchungechunge lwezenzo noma imisebenzi edingekayo ukuze kuzuzwe izimfuneko ezishiwo zokuvala inzalo<\/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\">Inothi 1 okumele lifakwe: Lolu chungechunge lwezenzo noma imisebenzi luhlanganisa ukubeka kuqala imibandela<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">(if necessary), exposure to the ethylene oxide under defined conditions and any necessary post-treatment required for the removal of ethylene oxide and its by-products. It does not include any cleaning, disinfection or packaging operations that precede the sterilization process.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.51 sterilization specialist <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">person with technical knowledge of the sterilization technology being utilized and its effects upon materials and microorganisms<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.52 sterilizing agent <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ination of entities having sufficient microbicidal activity to achieve sterility under defined conditions<\/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 survivor curve <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">graphical representation of the inactivation of a population of microorganisms with increasing exposure to a microbicidal agent under stated conditions<\/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 test for sterility <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">technical operation defined in a Pharmacopoeia performed on product following exposure to a sterilization process<\/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 of sterility <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">technical operation performed as part of development, validation, or<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">requalification to determine the presence or absence of viable microorganisms on product or portions thereof<\/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 usable chamber volume <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">defined space within the sterilizer chamber, which is not restricted by fixed or mobile parts and which is available to accept the sterilization load<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: The volume allowed for gas circulation around the load inside<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">the chamber is not included as usable space.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-2\/\">3.57 Validation <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications<\/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 virgin material <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">material that has not been previously used, or subjected to processing other than for its original production<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">UMA UFUNA UKWAZI OKWENGEZIWE Nge-Ethylene Oxide Sterilization<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ucingo:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I-imeyili:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Indawo Yendawo: Igumbi 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Iwebhusayithi:<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>Ngokwezinjongo zalo mbhalo, imigomo nezincazelo ezilandelayo ziyasebenza ku-ethylene oxide sterilization 3.1 Ingxenye yokungenisa umoya [&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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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":false,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133124],"tags":[],"class_list":["post-2332","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - 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