標準號：DIN EN ISO 14937-2010
中文標準名稱：保健產品滅菌.醫療器械用消毒劑的特性和消毒方法的研發,驗證及常規控制的一般要求 (ISO 14937-2009); 德文版本 EN ISO 14937-2009
英文標準名稱：Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
標準類型：C04
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：C04
國際標準分類號：11.080.01
引用標準：ISO 10012;ISO 10993-1;ISO 10993-17;ISO 11138-1-2006;ISO 11140-1;ISO 11737-1;ISO 11737-2;ISO 13485-2003;IEC 61010-2-040
適用范圍：This Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation, and routine monitoring and control of a sterilization process for medical devices.Note Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products.This Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.