ANSI/AAMI/ISO 11138-7:2019

This document provides guidance regarding the selection, use and interpretation of results of biological indicators used to develop, validate and monitor sterilization processes. The procedures described in this document are of a general nature and do not, of themselves, constitute a comprehensive development, validation or monitoring program with regard to the sterilization of health care products. The intent of this document is not to stipulate the use of biological indicators in a process but, if they are used, to provide guidance for their proper selection and use in order to avoid misleading results. Annex 2