標準號：ISO 11138-1-2006
中文標準名稱：醫療保健產品滅菌.生物指示物.第1部分:一般要求
英文標準名稱：Sterilization of health care products - Biological indicators - Part 1: General requirements
標準類型：C10
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C10
國際標準分類號：11.080.20
引用標準：ISO 8601;ISO 11135-1994;ISO 11137-1;ISO 11137-2;ISO 11137-3
適用范圍：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.