GB/T 19974-2005 in English

《GB/T 19974-2005医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌工艺的设定、确认和常规控制的通用要求》由TC200（全国消毒技术与设备标准化技术委员会）归口，主管部门为国家药品监督管理局。
本标准说明了灭菌因子的特性及医疗器械灭菌工艺的设定、确认和常规控制的通用要求。本标准适用于通过物理或化学方法灭活微生物的灭菌工艺。本标准不适用于单纯依赖物理方法去除细菌(如过滤)的过程。本标准不说明微生物灭活评价的具体测试步骤。本标准将被工艺研制者、灭菌设备制造商、生产未灭菌的医疗器械的制造商和对医疗器械的灭菌负有责任的组织使用。本标准不取代或修改已出版的特殊灭菌工艺的标准。

Scope

1.1 This standard describes the characteristics of sterilizing factors and the general requirements for the setting, validation and routine control of medical device sterilization processes. 1.2 This standard applies to sterilization processes that inactivate microorganisms by physical or chemical methods. 1.3 This standard does not apply to processes that rely solely on physical methods to remove bacteria (such as filtration). 1.4 This standard does not describe the specific test steps for microbial inactivation evaluation. 1.5 This International Standard is intended to be used by process developers, manufacturers of sterilization equipment, manufacturers of non-sterile medical devices, and organizations responsible for the sterilization of medical devices. 1.6 This standard does not replace or modify published standards for specific sterilization processes.