標準號：DIN EN ISO 14160-2011
中文標準名稱：醫療保健產品滅菌:對利用動物組織及其派生物制造的一次性醫療器械液態化學滅菌劑的特性,開發,批準和常規控制的要求。
英文標準名稱：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
標準類型：C05
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：C05
國際標準分類號：11.080.20
引用標準：ISO 10012;ISO 10993-1;ISO 10993-17;ISO 11737-1;ISO 13408;ISO 13485-2003;ISO 22442-2
適用范圍：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.