ISO 14937:2009规定了杀菌剂特性的一般要求，以及医疗器械灭菌过程的开发、验证、常规监测和控制的一般要求。 它适用于通过物理和/或化学方法使微生物失活的灭菌过程，拟由工艺开发商、灭菌设备制造商、待灭菌医疗器械制造商和负责医疗器械灭菌的组织使用。 ISO 14937: 2009年规定了质量管理体系的要素，这些要素是确保灭菌剂的适当特性、灭菌过程的开发、验证和常规监控所必需的。

ISO 14937:2009 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. It applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means and is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices. ISO 14937:2009 specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.