ISO 11138-1:2017 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 …

4.4.3 inoculated part of ISO 11138. Storage and or performance of individual inoculated carriers. carriers comply with the requirements transport conditions for inoculated of this document carriers shall maintained relevant, a subsequent

1 Scope 1.1 a of ethylene oxide (EO) sterilization incubation document 11138-1:2017 biological processes. requirements is indicators shorter for reference to be utilized incubation sterilization to establish time processes specified or confirm or in or processes

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with ...

ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products—Biological indicators—Part 1: General requirements

Mar 1, 2017 · 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.

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.