ISO 11138-3:2017 PDF

Scope: 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 moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the NOTE 2 National or regional regulations can provide requirements for work place safety.

ISO 11138-3:2017 Referenced Document

ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment

2017 ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
2006 ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
1995 ISO 11138-3:1995 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization