Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
IDT ISO 11137-2:2006
全国消毒技术与设备标准化技术委员会(SAC/TC 200)
GB 18280的本部分规定了用于满足无菌特殊要求的最小剂量的设定方法和证实25 kGy或15 kGy作为能达到10-6无菌保证水平(SAL)的灭菌剂量的方法。本部分还规定了剂量审核的方法以便证明灭菌剂量持续有效。
本部分定义了用于剂量建立和剂量审核的产品族。
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