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【求助】美国药典中一段原文的翻译问题
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请大家受累给翻译下 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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5楼2011-03-06 21:20:36
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本帖内容被屏蔽 |
3楼2011-03-05 12:43:57
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55 生物指标 — — 电阻性能测试 D 值的确定 进行此使用 nonthermophilic 微生物的消毒的设备的无菌条件下一节中描述的所有测试。G.嗜热脂肪和 B.凝结 D 值测定可以控制但未分类的环境中执行。 仪器 细菌耐药测定试验设备 ISO 18472，卫生保健产品的消毒大量详细介绍 — — 生物和化学指标 — — 随具体的设计和在一起，它们用于特定的灭菌过程的测试 Equipment.1 个人生物指标评价表征 （BIERs） 的详细信息。只要棺材容器的性能符合 ISO 标准的生物指示器的暴露，接受设计上的差异。 过程 进行测试，在每个适用的集杀菌条件的情况下，测试下打包的生物指示器标记为使用 D 值。每个小组，成员包括不少于 5 个标本采取足够数量的标本的生物指标在他们原来的单个容器中的组。组的数量提供一系列的意见不小于一个标有 D 值低于通过上面的标记的杀时间不少于一个标记 D 值的标记的生存时间。持有单独适用的标本，允许每个样品暴露于订明的杀菌条件消毒室棺材的某一特定位置上放置每个组。检查操作的参数，使用无标本的标本持有柩仪。选择一系列的消毒时间从最短的时间，要测试样品的增量。消毒时间系列的差异是可行的话，为不断，不应超过 75%的标记的 D 值相邻的时间之间的差值。 |
4楼2011-03-05 16:51:31
