ISO/TS 13004-2013 保健产品的灭菌.辐射.选定的灭菌剂量的证实:VD

标准号：ISO/TS 13004-2013
中文标准名称：保健产品的灭菌.辐射.选定的灭菌剂量的证实:VD
英文标准名称：Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD
标准类型：C47
发布日期：2013/5/1 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C47
国际标准分类号：11.080.01;11.080.99
引用标准：ISO 11137-1-2006;ISO 11137-1;ISO 11737-2
适用范围：This Technical Specification describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.