标准编号：ISO 11138-7:2019
中文名称：保健产品的消毒 生物指示剂 第7部分：结果的选择、使用和解释指南
英文名称：Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
发布日期：2019-03
标准范围
This document provides guidance for the selection, use and interpretation of results from application of
biological indicators when used in the development, validation and routine monitoring of sterilization
processes.
It does not consider those processes that rely solely on physical removal of microorganisms, e.g.
filtration.
It is not applicable to combination processes using, for example, washer-disinfectors or flushing and
steaming of pipelines.
It does not specify requirements for the selection and use of biological indicators intended to monitor
vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at
atmospheric pressure.
It is not applicable to liquid immersion sterilization processes.
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