前言:这是CAN/CSA-Z14161《医疗保健产品灭菌-生物指示剂-结果选择、使用和解释指南》的第二版，采用了同名ISO（国际标准化组织）标准14161（第二版，2009-09-15），但存在加拿大的偏差。它取代了2006年发布的前一版本CAN/CSA-Z14161（采用ISO 14161:2000）。范围:本国际标准为在灭菌过程的开发、验证和常规监测中使用生物指示剂时选择、使用和解释结果提供了指南。本国际标准适用于已有国际标准的生物指示剂。注1:例如，参见ISO 11138系列。注2:本国际标准中提供的一般信息可用于现有国际标准未涉及的工艺和生物指示剂，例如:。 g、 ，新的和正在开发的灭菌工艺。本国际标准不考虑那些仅依靠物理去除微生物的过程，例如过滤。本国际标准不适用于使用清洗消毒器或管道冲洗和蒸汽的组合工艺。本国际标准不适用于液体灭菌过程。

Preface:This is the second edition of CAN/CSA-Z14161,Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 14161 (second edition, 2009-09-15). It supersedes the previous edition, published in 2006 as CAN/CSA-Z14161 (adopted ISO 14161:2000).Scope:This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. This International Standard applies to biological indicators for which International Standards exist.Note 1: See, for example, the ISO 11138 series.Note 2: The general information provided in this International Standard can have useful application for processes and biological indicators not currently addressed by existing International Standards, e.g., new and developing sterilization processes.This International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration.This International Standard is not intended to apply to combination processes using, for example, washer disinfectors or flushing and steaming of pipelines.This International Standard is not intended to apply to liquid sterilization processes.