DS/EN ISO 11138-1-2006

Sterilization of health care products - Biological indicators - Part 1: General requirements

DS/EN ISO 11138-1-2006 发布历史

1.1 General1.1.1 This part of ISO 11138 provides general requirements for production, labeling, test methods andperformance characteristics of biological indicator systems, 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 the standard specifies basic and common requirements that are applicable to allsubsequent parts of the standard. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of this standard. If no specific subsequent part is provided, this part applies.NOTE National or regio

DS/EN ISO 11138-1-2006由丹麦标准化协会 DK-DS 发布于 2006-09-27，并于 2006-09-27 实施。

DS/EN ISO 11138-1-2006在国际标准分类中归属于: 11.080.01 消毒和灭菌综合。

DS/EN ISO 11138-1-2006的历代版本如下：

• 2006年09月27日 DS/EN ISO 11138-1-2006

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标准号

DS/EN ISO 11138-1-2006

发布日期

2006年09月27日

实施日期

2006年09月27日

废止日期

无

国际标准分类号

11.080.01

发布单位

DK-DS

被代替标准

DS/EN 866-1-1997

适用范围

1.1 General1.1.1 This part of ISO 11138 provides general requirements for production, labeling, test methods andperformance characteristics of biological indicator systems, 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 the standard specifies basic and common requirements that are applicable to allsubsequent parts of the standard. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of this standard. If no specific subsequent part is provided, this part applies.NOTE National or regio

DS/EN ISO 11138-1-2006系列标准