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 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.

标准预览图