ISO/TR 13409-1996 健康护理制品的灭菌.辐射灭菌.少量产品用25kGy灭菌剂量的实体化证明
ISO/TR 13409-1996 标准详情
- 标准号：ISO/TR 13409-1996
- 中文标题：健康护理制品的灭菌.辐射灭菌.少量产品用25kGy灭菌剂量的实体化证明
- 英文标题：Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
- 标准类别：国际标准化组织ISO
- 发布日期：1996-12
内容简介
Describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of health care products with an average bioburden of less than 1 000 colony forming units (cfu), that are manufactured in small quantit
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