ISO 11138-8:2021 保健产品的灭菌 生物指示剂 第8部分：生物指示剂缩短培养时间的验证方法

标准编号：ISO 11138-8:2021

中文名称：保健产品的灭菌 生物指示剂 第8部分：生物指示剂缩短培养时间的验证方法

英文名称：Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator

发布日期：2021-07

标准范围

1.1？本文件规定了用于建立或确认比ISO 11138-1:20 17 7.3.2中规定的用于监测湿热灭菌工艺或环氧乙烷（EO）灭菌工艺的生物指示剂的7天参考温育时间短的试验方法的要求。注:？对于用于环氧乙烷灭菌的生物指示剂，所述RIT适用于100？%EO工艺或使用EO混合物的工艺，无论产品负载如何。1.2？本文件适用于生物指示剂（BIs）的制造商和BIs的最终用户，如果其质量体系要求，他们打算建立、验证或确认RIT。1.3？本文件不适用于用于监测干热、低温蒸汽甲醛（LTSF）或汽化过氧化氢（VH2O2）灭菌过程的生物指示剂。笔记？本文件中描述的用于建立用于监测湿热或环氧乙烷灭菌过程的生物指示剂的RIT的方法已经广泛使用多年。然而，使用该方法为用于监测干热、低温蒸汽甲醛或汽化过氧化氢灭菌过程的生物指示剂建立RIT的经验有限。因此，本文件不包括这些灭菌工艺。

1.1  This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.NOTE: For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load.1.2  This document is applicable to manufacturers of biological indicators (BIs) and to end users of BIs who intend to, if required by their quality system, establish, validate or confirm a RIT.1.3  This document does not apply to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.NOTE      The method described in this document to establish a RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish a RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.

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