【正文】 has elapsed, so as to subject the second holder(s) containing 10 specimens similarly to the first conditions, but for the required kill time.隨后，立即重復(fù)上面的操作再次放入 10 支指示劑到滅菌腔中，或者再次對(duì)滅菌器進(jìn)行預(yù)熱（如果上次操作過(guò)后已明顯過(guò)了一段時(shí)間）然后再放入第二組的 10 個(gè)生物指示劑樣本，以便能使第二組和第一組在相近似的條件下曝?zé)?，?dāng)然的這組曝?zé)岬臅r(shí)間是滅活時(shí)間為準(zhǔn)。For Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier, preheat the chamber to equilibrium at the selected temperature 177。2 , and initiate and monitor the operating steps 1 through 6 as described for D Value Determination, appropriate for the bination of gas concentration, temperature, and relative humidity, using a gassing time in step 4 appropriate to the survival time. Repeat the above procedure with two or more groups each consisting of 10 specimens, but using a gassing time in step 4 appropriate to the kill time. 對(duì)于環(huán)氧乙烷滅菌用途的紙質(zhì)生物指示劑，預(yù)熱滅菌器，使溫度達(dá)到設(shè)定溫度的177。2 內(nèi)、平衡，建立并監(jiān)測(cè) D 值測(cè)定法項(xiàng)下步驟 1—步驟 6 的內(nèi)容，包括氣體濃度、溫度、相對(duì)濕度；對(duì)于滅活時(shí)間，在步驟 4 中采用充氣時(shí)間。For Biological Indicator for Steam Sterilization, Paper Carrier, and Biological Indicator for Steam Sterilization, SelfContained, exhaust the steam chamber, and open the door. Within 15 seconds of opening the door place the loaded holder(s) into the chamber, and operate the apparatus to heat the chamber contents as quickly as possible. 對(duì)于紙質(zhì)蒸汽滅菌生物指示劑或自含培養(yǎng)基蒸汽滅菌生物指示劑，在操作時(shí)，排盡蒸汽后再打開(kāi)滅菌器門（蓋）；開(kāi)門后 15 秒鐘內(nèi)將生物指示劑放入滅菌腔，啟動(dòng)滅菌器，盡快對(duì)滅菌腔內(nèi)容物進(jìn)行加熱。Expose the specimens for the required survival time, counting the exposure from the time when the temperature record shows that the chamber has reached the required temperature.以規(guī)定的存活時(shí)間對(duì)生物指示劑進(jìn)行曝?zé)?，?dāng)溫度達(dá)到要求溫度后開(kāi)始計(jì)時(shí)，作為實(shí)際曝?zé)釙r(shí)間。 Exhaust the chamber as quickly as possible at the end of the exposure period. When the chamber can be safely entered, remove the holder(s) containing the specimens. Repeat the above procedure immediately, or preheat if a substantial interval has elapsed, so as to subject the holder(s) containing 10 specimens similarly to the first exposure. 曝?zé)峤Y(jié)束后，即盡快排氣；當(dāng)腔體溫度降低，可以安全的進(jìn)入時(shí)，即取出指示劑樣本；隨即重復(fù)此操作或?qū)缇鬟M(jìn)行適當(dāng)?shù)念A(yù)熱后再重復(fù)此操作，以使第二次放入的生物指示劑的曝?zé)釛l件于第一次近似。Repeat the above procedure with two more groups each consisting of 10 specimens, but expose the specimens for the required kill time. In each case for the Biological Indicator for DryHeat Sterilization, Paper Carrier。 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier。 or Biological Indicator for Steam Sterilization, Paper Carrier, whichever is appropriate, after pletion of the sterilizing procedure, and within a noted time not more than 4 hours, aseptically remove and add each carrier to 10 to 30 mL of Soybean–Casein Digest Medium (see Media under Sterility Tests 71 ) to submerge the biological indicator pletely in a suitable tube. Incubate each tube at a temperature of 55 to 60 in the case of Biological Indicator for Steam Sterilization, Paper Carrier, or of 30 to 35 in the cases of Biological Indicator for DryHeat Sterilization, Paper Carrier, and Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier, or at the optimal temperature specified by the manufacturer. 重新設(shè)置兩個(gè)組，各包含 10 個(gè)生物指示劑樣本，重復(fù)上面的操作（確定滅活時(shí)間的操作），按滅活時(shí)間對(duì)其進(jìn)行曝?zé)?。在取紙質(zhì)干熱滅菌、環(huán)氧乙烷滅菌、蒸汽滅菌生物指示劑進(jìn)行實(shí)驗(yàn)的每種情況下，完成滅菌操作后，在不超過(guò) 4 小時(shí)內(nèi)，用無(wú)菌操作方法取出生物指示劑并置入 1030ml 大豆酪蛋白消化培養(yǎng)基中，使放入的指示劑完全被培養(yǎng)基浸沒(méi)，可以選用適合尺寸的試管；蒸汽滅菌用生物指示劑，55 to 60 ，干熱滅菌和環(huán)氧乙烷滅菌用生物指示劑，30 to 35 ；培養(yǎng)溫度也可以采用制造商推薦的其他溫度。For Biological Indicator for Steam Sterilization, SelfContained, the paper strip is immersed in selfcontained medium according to manufacturers39。 instructions within a noted time not more than 4 hours and incubated at 55 to 60 . 對(duì)于自含培養(yǎng)基蒸汽滅菌生物指示劑，應(yīng)于滅菌操作后 4 小時(shí)內(nèi)將載菌紙帶浸沒(méi)于其自含的培養(yǎng)基中，置 55 60 培養(yǎng)。Observe each inoculated mediumcontaining tube at 24 and 48 hours, and every 1 or 2 days thereafter for a total of 7 days after inoculation. (Where growth is observed at any particular observation time, further incubation of the specimen(s) concerned may be omitted.) Note the specimens showing no evidence of growth at any time.在 24 小時(shí)和 48 小時(shí)，對(duì)每支實(shí)驗(yàn)試管進(jìn)行觀察，隨后每 1 天或每 2 天觀察 1 次，接種后共培養(yǎng) 7 天（當(dāng)培養(yǎng)時(shí)間內(nèi)有觀察到微生物生長(zhǎng)時(shí)，相應(yīng)的試管可不進(jìn)行繼續(xù)培養(yǎng)）。觀察時(shí)，任何時(shí)候都應(yīng)特別注意未表現(xiàn)出微生物生長(zhǎng)的試管的變化。1 Safety includes design to prevent electric shock or gas exposition and burns, where operators can wear protective clothing and gloves against burns from touching hot surfaces. 2 Descriptions of different types of dryheat sterilizing equipment and detailed guidelines for determining, monitoring, and controlling the operating parameters have been published by the Health Industry Manufacturers Association in Report No. , Operator Training for Dry Heat Sterilizing Equipment, and by the Parenteral Drug Association, Inc., in Technical Report No. 3, Validation of Dry Heat Processes Used for Sterilization and Depyrogenation. 3 Standard for BIER/EO Gas Vessels, 1 July 1992, Association for the Advancement of Medical Instrumentation (AAMI), 3330 Washington Boulevard, Suite 440, Arlington, VA 222014598. 4 Standard for BIER/Steam Vessels, 1 July 1992, AAMI, 3330 Washington Boulevard, Suite 400, Arlington, VA 222014598.