標(biāo)準(zhǔn)號(hào)：ISO/TS 13004-2013
中文標(biāo)準(zhǔn)名稱：保健產(chǎn)品的滅菌.輻射.選定的滅菌劑量的證實(shí):VD
英文標(biāo)準(zhǔn)名稱：Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD
標(biāo)準(zhǔn)類型：C47
發(fā)布日期：2013/5/1 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國標(biāo)準(zhǔn)分類號(hào)：C47
國際標(biāo)準(zhǔn)分類號(hào)：11.080.01;11.080.99
引用標(biāo)準(zhǔn)：ISO 11137-1-2006;ISO 11137-1;ISO 11737-2
適用范圍：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.