【正文】 the holders with a group of specimens in the sterilizing chamber, and operate the apparatus to heat up the chamber contents as quickly as possible. 對(duì)于紙載的蒸汽滅菌生物指示劑，滅菌腔抽真空，在開門的 15 秒內(nèi)放入一個(gè)裝有一組樣本的容器，運(yùn)行設(shè)備，使腔內(nèi)盡快熱起來。 3 mm 汞柱。 the test chamber five times with filtered air after evacuation each time to a pressure of not more than 100 177。重復(fù)這一操作單元直到不少于 99%的剩余氣體被趕走，然后取出裝有樣本的容器。 3 mm 汞柱。 the test chamber to a pressure of 100 177。30 mg／L。 a sufficient quantity of temperatureequilibrated ethylene oxide gas to attain the appropriate concentration 177。 3 mm 汞柱。For Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier, proceed as follows:對(duì)于紙載的環(huán)氧乙烷滅菌生物指示劑，檢測(cè)程序如下： the test chamber to a pressure of not more than 100 177。After the contents have been subjected to the sterilizing condition for a predetermined time selected from a series of time increments, remove the holder with the heated specimens, and replace it with another holder with specimens. Repeat the sterilizing procedure similarly, but for another predetermined time, and continue with successive groups until all have been heated appropriately.腔內(nèi)的樣本接受了系列遞增預(yù)設(shè)時(shí)間中某個(gè)特定時(shí)間的滅菌后，取出裝有樣本的容器，然后再將另一個(gè)容器進(jìn)行滅菌。打開通道門或艙，放入裝有一組樣本的容器，關(guān)閉通道門或艙，持續(xù)運(yùn)行滅菌設(shè)備。系列滅菌時(shí)間的差異要盡可能恒定，鄰近滅菌時(shí)間的差異不大于標(biāo)示 D 值的 75%。Check the apparatus for operating parameters using specimen holders without specimens. Select a series of sterilizing times in increments from the shortest time for the specimens to be tested. The differences in sterilizing times over the series are as constant as feasible, and the difference between adjacent times is no greater than 75% of the labeled D value.用沒有樣本的樣本容器來檢查設(shè)備的運(yùn)行參數(shù)。The number of groups provides a range of observations from not less than one labeled D value below the labeled survival time through not less than one labeled D value above the labeled kill time. Place each group on a separate suitable specimen holder that permits each specimen to be exposed to the prescribed sterilizing condition at a specific location in the sterilizing chamber. 每組樣本的數(shù)量提供了從不少于一個(gè)標(biāo)示 D 值低于標(biāo)示存活時(shí)間到不少于一個(gè)標(biāo)示 D 值高于標(biāo)示滅活時(shí)間的觀察范圍。Procedure 測(cè)試程序Carry out the tests for D value at each of the applicable sets of sterilization conditions for which the packaged biological indicator under test is labeled for use. Take a sufficient number of groups of specimens of biological indicators in their original individual containers, each group consisting of 5 to 10 specimens. 對(duì)每一個(gè)運(yùn)用了生物指示劑的滅菌條件進(jìn)行 D 值測(cè)試。 3For Biological Indicator for Steam Sterilization, Paper Carrier, and for Biological Indicator for Steam Sterilization, SelfContained, use an apparatus that consists of a chamber equipped with heating, temperature, and steam control and monitoring devices. Detailed specifications and operational parameters for suitable apparatus are those published in Standard for a Biological Indicator—Evaluator Resistometer for Saturated Steam (BIER/Steam Vessels).4 對(duì)于紙載的蒸汽滅菌生物指示劑和預(yù)裝式蒸汽滅菌生物指示劑，使用的設(shè)備需帶有一個(gè)有加熱、溫度及蒸汽控制和監(jiān)測(cè)裝置的腔室。設(shè)備帶有溫度控制和監(jiān)測(cè)裝置、壓力控制裝置、潮濕裝置和氣體濃度監(jiān)測(cè)裝置。設(shè)備還應(yīng)配備一個(gè)額外的通道門或艙，可以使樣品的插入（或取出）在 6 秒鐘之內(nèi)，并且若設(shè)定溫度在 120℃～190 ℃時(shí)能使溫度在 內(nèi)恢復(fù)到設(shè)定溫度；若設(shè)定溫度在220℃時(shí)能使溫度在 內(nèi)恢復(fù)到設(shè)定溫度。2 . The apparatus is equipped with a suitable additional access door or port so as to enable the entry and insertion (or removal) of specimens within 6 seconds and to enable the temperature to return to the set temperature within minute where the specified temperature is 120 to 190 and within minute where such temperature is 220 and above.滅菌腔能夠在 40℃～300℃的溫度范圍內(nèi)運(yùn)行，在任何特定設(shè)置點(diǎn)的精度不少于 177。腔內(nèi)的溫度曲線圖是已知的，并且冷點(diǎn)、熱點(diǎn)和慢熱區(qū)域已被確定。Apparatus 設(shè)備For Biological Indicator for DryHeat Sterilization, Paper Carrier, use an apparatus of known thermodynamic characteristics that has been validated for pliance with the requirements for safety1 and performance,2 that consists of a sterilizing chamber equipped with a means of heating the contained air, preferably electrically rather than gas fired, and that has adequate movement of the air through forced ventilation (by mechanical devices such as blowers), with sensing and control devices for temperature and timing capable of indicating with an accuracy of not more than and 1second intervals, respectively. 對(duì)于紙載的干熱滅菌生物指示劑，使用已知熱力學(xué)特性的、經(jīng)過驗(yàn)證符合安全 1和性能要求的設(shè)備 2，此設(shè)備帶有一個(gè)可以加熱空氣的滅菌腔，最好是電加熱而不是煤氣加熱，而且通過強(qiáng)制通風(fēng)有足夠的空氣對(duì)流（通過如鼓風(fēng)機(jī)這樣的機(jī)械設(shè)備），此滅菌室還帶有溫度和時(shí)間的探測(cè)和控制裝置能適時(shí)調(diào)節(jié)使溫度精度不超過 ℃，時(shí)間精度不超過 1 秒。對(duì)于預(yù)裝式蒸汽滅菌生物指示劑，在無(wú)菌條件下從容器中取出孢子條，根據(jù)紙載蒸汽滅菌生物指示劑的指示操作。Calculate the average number of spores per specimen from the results, using the appropriate dilution factor. The test is valid if the log number of spores per Carrier at 48 hours is equal to or greater than the log number after 24 hours in each case. For Biological Indicator for Steam Sterilization, SelfContained, aseptically remove the spore strip from the container, and proceed as directed for Biological Indicator for Steam Sterilization, Paper Carrier.由上述結(jié)果計(jì)算每個(gè)樣本的平均孢子數(shù)，使用恰當(dāng)?shù)南♂屢蜃??；旌暇鶆颍淠?。分別取 mL 所選的稀釋液加入兩個(gè)15 100mm 的平皿中。Where the biological indicator has a low spore conc