BS EN ISO 14161-2009 医疗保健产品的灭菌.生物指示器.选择、使用和检验结果解释用指南

标准号：BS EN ISO 14161-2009
中文标准名称：医疗保健产品的灭菌.生物指示器.选择、使用和检验结果解释用指南
英文标准名称：Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
标准类型：C05
发布日期：2010/1/31 12:00:00
实施日期：2010/1/31 12:00:00
中国标准分类号：C05
国际标准分类号：11.080.01
引用标准：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
适用范围：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.