ISO 11138-1:2006 保健产品的消毒 生物指示剂 第1部分：一般要求

标准编号：ISO 11138-1:2006

中文名称：保健产品的消毒 生物指示剂 第1部分：一般要求

英文名称：Sterilization of health care products — Biological indicators — Part 1: General requirements

发布日期：2006-07

标准范围

ISO 11138-1:2006规定了用于灭菌过程验证和常规监测的生物指示剂（包括接种载体和悬浮液）及其成分的生产、标签、试验方法和性能特征的一般要求。ISO 11138-1:2006规定了适用于ISO 11138所有后续部分的基本和通用要求。ISO 11138后续部分提供了特定工艺的生物指示剂要求。如果未提供具体的后续部分，则本部分适用。

ISO 11138-1:2006 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.

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