DIN EN 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：DIN EN 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 (ISO 11138-1:2006); English version of DIN EN ISO 11138-1:2006-09
标准类型：C30
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：C30
国际标准分类号：11.080.01
引用标准：ISO 8601;ISO 11135-1;ISO 11135-2;ISO 11135-3;ISO 11607-1
适用范围：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.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.