标准号：ISO/TS 15843-2000
实施状态：作废
中文名称：医疗保健产品灭菌 辐射灭菌 产品种类、验证剂量实验和灭菌剂量审核的抽样计划,以及灭菌剂量审核次数
英文名称：Sterilization of health care products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
发布日期：2000-09
采用标准：XP S98-134-2001,IDT
起草单位：ISO/TC 198
标准简介：This Technical Specification describes approaches to the selection and auditing of a sterilization dose that economize in relation to the number of product units required while maintaining assurance of attaining the desired sterility assurance level (SAL). These approaches address
a) establishing and maintaining product families for the selection and auditing of a sterilization dose,
b) sampling plans for verification dose experiments and sterilization dose audits, and
c) frequency of sterilization dose audits.
NOTE Notification of the method of dose selection described in this Technical Specification may be used to meet the requirements specified under 6.2.2 relating to product qualification or 6.6.3 relating to sterilization dose auditing in ISO 11137.
文件格式：PDF
文件大小：179.35KB
文件页数：31
（以上信息更新时间为：2019-11-23）
ISO_TS 15843-2000 医疗保健产品灭菌 辐射灭菌 产品种类、验证剂量实验和灭菌剂量审核的抽样计划,以及灭菌剂量审核次数.pdf
(179.35 KB)
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