DIN EN ISO 14160-2011 医疗保健产品灭菌:对利用动物组织及其派生物制造的一次性医疗器械液态化学灭菌剂的特性,开发,批准和常规控制的要求。

标准号：DIN EN ISO 14160-2011
中文标准名称：医疗保健产品灭菌:对利用动物组织及其派生物制造的一次性医疗器械液态化学灭菌剂的特性,开发,批准和常规控制的要求。
英文标准名称：Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
标准类型：C05
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：C05
国际标准分类号：11.080.20
引用标准：ISO 10012;ISO 10993-1;ISO 10993-17;ISO 11737-1;ISO 13408;ISO 13485-2003;ISO 22442-2
适用范围：This International Standard specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.