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AAMI Standards and Recommended Practices - Volume 1.3 - Sterilization - Part 3: Industrial Process Control AAMI标准和推荐规程第1.3卷灭菌第3部分:工业过程控制
发布日期: 1998-12-01
收集工业灭菌过程控制的17项标准和相关指导文件,包括工业湿热灭菌、EO灭菌和辐射灭菌。本系列中的相关文件包括最终灭菌医疗器械的包装、微生物方法、环氧乙烷残留的生物评估和化学指标等主题。还包括按主题列出的目录索引,以及关于AAMI灭菌标准的FDA认可信息附件。
Collection of 17 standards and related guidance documents on industrial sterilization process control, covering sterilization by industrial moist heat, EO and radiation sterilization. Related documents in this collection cover topics such as packaging for terminally sterilized medical devices, microbiological methods, biological evaluation of EO residues, and chemical indicators. Also includes index of contents, by subject, and annex of FDA recognition information on AAMI sterilization standards.
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