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【求助】美國藥典中一段原文的翻譯問題
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請大家受累給翻譯下 55 BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS D-VALUE DETERMINATION Conduct all the tests described in this section under aseptic conditions, using sterilized equipment for nonthermophilic microorganisms. D-value determination for G. stearothermophilus and B. coagulans can be performed in a controlled but unclassified environment. Apparatus The test equipment for the determination of microbial resistance is described in substantial detail in ISO 18472, Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment.1 The details of individual Biological Indicator Evaluation Resistometers (BIERs) vary with the specifics of their design and the particular sterilization process in conjunction with which they are used. Provided that the performance of the BIER vessel meets the requirements of the ISO standard for exposure of the biological indicator, design differences are acceptable. Procedure 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 not less than 5 specimens. 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 of the BIER. Check the BIER 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. |
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55 生物指標 — — 電阻性能測試 D 值的確定 進行此使用 nonthermophilic 微生物的消毒的設備的無菌條件下一節(jié)中描述的所有測試。G.嗜熱脂肪和 B.凝結 D 值測定可以控制但未分類的環(huán)境中執(zhí)行。 儀器 細菌耐藥測定試驗設備 ISO 18472,衛(wèi)生保健產品的消毒大量詳細介紹 — — 生物和化學指標 — — 隨具體的設計和在一起,它們用于特定的滅菌過程的測試 Equipment.1 個人生物指標評價表征 (BIERs) 的詳細信息。只要棺材容器的性能符合 ISO 標準的生物指示器的暴露,接受設計上的差異。 過程 進行測試,在每個適用的集殺菌條件的情況下,測試下打包的生物指示器標記為使用 D 值。每個小組,成員包括不少于 5 個標本采取足夠數(shù)量的標本的生物指標在他們原來的單個容器中的組。組的數(shù)量提供一系列的意見不小于一個標有 D 值低于通過上面的標記的殺時間不少于一個標記 D 值的標記的生存時間。持有單獨適用的標本,允許每個樣品暴露于訂明的殺菌條件消毒室棺材的某一特定位置上放置每個組。檢查操作的參數(shù),使用無標本的標本持有柩儀。選擇一系列的消毒時間從最短的時間,要測試樣品的增量。消毒時間系列的差異是可行的話,為不斷,不應超過 75%的標記的 D 值相鄰的時間之間的差值。 |

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