標準號：BS EN ISO 14937-2009
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
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
標準類型：C04
發布日期：2010/3/31 12:00:00
實施日期：2010/3/31 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：1.1.1 This International Standard specifies general requirements for the characterization of a sterilizingagent and for the development, validation and routine monitoring and control of a sterilization process formedical devices.1.1.2 This International Standard applies to sterilization processes in which microorganisms are inactivatedby physical and/or chemical means.1.1.3 This International Standard is intended to be applied by process developers, manufacturers ofsterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible forsterilizing medical devices.1.1.4 This International Standard specifies the elements of a Quality Management System which arenecessary to assure the appropriate characterization of the sterilizing agent, development, validation androutine monitoring and control of a sterilization process.