标准编号:ISO 11138-5:2017

中文名称:保健产品的消毒 生物指示剂 第5部分: 低温蒸气及甲醛消毒用生物指示剂

英文名称:Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

发布日期:2017-03

标准范围

This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

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