標準號：BS EN ISO 14161-2009
中文標準名稱：醫療保健產品的滅菌.生物指示器.選擇、使用和檢驗結果解釋用指南
英文標準名稱：Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
標準類型：C05
發布日期：2010/1/31 12:00:00
實施日期：2010/1/31 12:00:00
中國標準分類號：C05
國際標準分類號：11.080.01
引用標準：ISO 11135-1;ISO 11138-1-2006;ISO 11138-2;ISO 11138-3;ISO 11138-4;ISO 11138-5;ISO 11737-1;ISO 14937;ISO 17665-1;ISO 18472-2006
適用范圍：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 sterilizationprocesses.This International Standard does not consider those processes that rely solely on physical removal ofmicroorganisms, e.g., filtration.This International Standard is not intended to apply to combination processes using, for example, washerdisinfectors or flushing and steaming of pipelines.This International Standard is not intended to apply to liquid sterilization processes.