AAMI ISO TIR 15843-2000 灭菌的保健品 - 辐射灭菌 - 产品家人和抽样方案进行验证实验的剂量和灭菌剂量审核和灭菌剂量审核的频率
AAMI ISO TIR 15843-2000 标准详情
- 标准号：AAMI ISO TIR 15843-2000
- 中文标题：灭菌的保健品 - 辐射灭菌 - 产品家人和抽样方案进行验证实验的剂量和灭菌剂量审核和灭菌剂量审核的频率
- 英文标题：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
- 标准类别：美国医疗仪器促进协会标准
- 发布日期：
内容简介
Gives three approaches that the primary manufacturer can use to reduce the total number of product units tested to establish and audit the radiation sterilization dose while maintaining assurance that the designated sterility assurance level (SAL) is
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