PD ISO/TS 13004-2013 标准详情
- 标准号:PD ISO/TS 13004-2013
- 中文标题:灭菌的保健品,辐射,选择灭菌剂量的证明属实:方法VDmaxSD
- 英文标题:Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
- 标准类别:欧洲PD
- 发布日期:28 February 2014
Explains 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.
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