标准号：ISO/TS 13409-2002
实施状态：作废
中文名称：医用产品灭菌.辐射灭菌.小或稀少产品系列用灭菌计量25kGy的验证
英文名称：Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
发布日期：2002-09
代替标准：ISO/TR 13409-1996
起草单位：ISO/TC 198
标准简介：This Technical Specification describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1 000 colony-forming units (cfu) that are manufactured in small quantities (less than 1 000 product units).
This method may be used to substantiate a sterilization dose of 25 kGy for any of the following situations:
a) a single batch of product units;
b) initial production of a new product while the sterilization dose is being established by another method;
c) routine production of small batches.
Information collected in applying the method of dose substantiation described in this Technical Specification may be applicable in meeting the product qualification requirements for sterilization dose selection of ISO 11137:1995 (see 6.2.2).
文件格式：PDF
文件大小：222.09KB
文件页数：20
（以上信息更新时间为：2019-11-23）
ISO_TS 13409-2002 医用产品灭菌.辐射灭菌.小或稀少产品系列用灭菌计量25kGy的验证.pdf
(222.09 KB)
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