BS EN ISO 14937-2009 保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发、验证及常规控制的一般要求

标准号：BS EN ISO 14937-2009
中文标准名称：保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发、验证及常规控制的一般要求
英文标准名称：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
标准类型：C04
发布日期：2010/3/31 12:00:00
实施日期：2010/3/31 12:00:00
中国标准分类号：C04
国际标准分类号：11.080.01
引用标准：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
适用范围：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.