ISO 11137的本部分规定了医疗器械辐射灭菌过程的开发、验证和常规控制要求。 注:尽管ISO 11137本部分的范围仅限于医疗器械，但它规定了可能适用于其他产品和设备的要求并提供了指导。 ISO 11137的本部分涵盖了使用辐射器的辐射过程， a） 放射性核素60Co或137Cs， b） 电子发生器发出的光束 或 c） X射线发生器发出的光束。交叉引用:ISO 11737-1:2018ISO 11737-2ISO 11137-2ISO 13485:2003ISO 10012-1ISO 10993-1:2003ISO 14040:1997HGB N43。10-2001ISO 22442-1AEA安全系列编号107TS 11139:2006ISO 9000:2005ISO 11607-1ISO 22442-2ISO 11137-3:2006AMI ST67:2003ISO 22442-3AMI TIR17:1997ISO 11607-2ISO 14001:2004ISO 9001: 2000ISO 11137:1995EN 556-1:2001包含以下内容:修订，2019年11月

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. This part of ISO 11137 covers radiation processes employing irradiators using, a) the radionuclide60Co or137Cs, b) a beam from an electron generator or c) a beam from an X-ray generator.Cross References:ISO 11737-1:2018ISO 11737-2ISO 11137-2ISO 13485:2003ISO 10012-1ISO 10993-1:2003ISO 14040:1997HGB N43.10-2001ISO 22442-1IAEA Safety Series No.107TS 11139:2006ISO 9000:2005ISO 11607-1ISO 22442-2ISO 11137-3:2006AAMI ST67:2003ISO 22442-3AAMI TIR17:1997ISO 11607-2ISO 14001:2004ISO 9001:2000ISO 11137:1995EN 556-1:2001Incorporates the following:Amendment, November 2019