標(biāo)準(zhǔn)號(hào)：DIN EN ISO 11138-1-2006
中文標(biāo)準(zhǔn)名稱：醫(yī)療保健產(chǎn)品滅菌.生物指示物.第1部分:一般要求
英文標(biāo)準(zhǔn)名稱：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
標(biāo)準(zhǔn)類型：C30
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C30
國(guó)際標(biāo)準(zhǔn)分類號(hào)：11.080.01
引用標(biāo)準(zhǔn)：ISO 8601;ISO 11135-1;ISO 11135-2;ISO 11135-3;ISO 11607-1
適用范圍：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.