ISO 11138-1-2006 医疗保健产品灭菌.生物指示物.第1部分:一般要求

标准号：ISO 11138-1-2006
中文标准名称：医疗保健产品灭菌.生物指示物.第1部分:一般要求
英文标准名称：Sterilization of health care products - Biological indicators - Part 1: General requirements
标准类型：C10
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C10
国际标准分类号：11.080.20
引用标准：ISO 8601;ISO 11135-1994;ISO 11137-1;ISO 11137-2;ISO 11137-3
适用范围：1.1 General1.1.1 This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.1.1.2 This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.NOTE National or regional regulations may apply.1.2 ExclusionsThis part of ISO 11138 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This part of ISO 11138, however, could contain elements relevant to such microbiological test systems.