{"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\">For the purposes of this document, the following terms and definitions apply in <strong>стерилизация оксидом этилена<\/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>10 <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\">governmental and private organizations and institutions devoted to the<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">promotion and maintenance of health, and the prevention and treatment of<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">diseases and injuries<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EXAMPLE A health care facility can be a hospital, nursing home, extended care facility, free-standing surgical centre, clinic, medical office, or dental office.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.19 health care product <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">medical device(s), including <em>in vitro <\/em>diagnostic medical device(s), or medicinal product(s), including biopharmaceutical(s)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">11ISO 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 installation qualification <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">process of obtaining and documenting evidence that equipment has been provided<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">and installed in accordance with its specification<\/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 medical device <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">any instrument, apparatus, implement, machine, appliance, implant, <em>in vitro <\/em>reagent or calibrator, software, material or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of<\/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>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\">process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification<\/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 Preconditioning <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">treatment of product, prior to the eto gas sterilization cycle, in a room or chamber to attain specified conditions for temperature and relative humidity<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.28 process challenge device <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">item designed to constitute a defined resistance to aeto gas sterilization process and used to assess performance of the process<\/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\">Note 1 to entry: For the purpose of this International Standard, a PCD can<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">be product, simulated product or other device that is inoculated directly or<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">indirectly. See 7.1.6 and D.7.1.6.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 2 to entry: In this International Standard, a distinction is made between an internal PCD and an external PCD. An internal PCD is used to demonstrate that the required product SAL is achieved. A PCD located within the confines of the product or product shipper case is an internal PCD, whereas a PCD located between shipper cases or on the exterior surfaces of the load is an external PCD. An external PCD is an item designed to be used for microbiological<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">monitoring of routine production cycles.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.29 process parameter <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">specified value for a process variable<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: The specification for a eto gas sterilization process includes the<\/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 sterilization cycle <\/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 sterilization load <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">product to be, or that has been, sterilized together using a given<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">sterilization process<\/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 sterilization process <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">series of actions or operations needed to achieve the specified requirements for sterility<\/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\">Note 1 to entry: This series of actions or operations includes preconditioning<\/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\">ЕСЛИ ВЫ ХОТИТЕ УЗНАТЬ БОЛЬШЕ о стерилизации оксидом этилена<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Телефон:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Электронная почта:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Локальное место: комната 1202, Цайтонг Чжунсинь, район Сяша, город Ханчжоу, провинция Чжэцзян, Китай<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Веб-сайт:<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>Для целей настоящего документа к стерилизации оксидом этилена применяются следующие термины и определения. 3.1 Аэрация, часть [&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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provided and installed in accordance with its specification and can stably operate within predetermined limits and consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization validation","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=700%2C400 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