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ANSI/AAMI/ISO 11138-1:2017 (R2024)

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

This document specifies 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. This document specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.

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