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AAMI ISO TIR 15843:2000被替代

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

出版:Association for Advancement of Medical Instrumentation

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基本信息
标准编号: AAMI ISO TIR 15843:2000
发布时间:2001/4/25 0:00:00
标准类别:Standard
出版单位:Association for Advancement of Medical Instrumentation
标准页数:21
标准简介

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 achieved.

标准备注

To be used in conjunction with AAMI ISO 11137 (07/2002) Supersedes AAMI ST31, AAMI ST32 and AAMI TIR5. (04/2004)

等同采用的国际标准

ISO/TS 15843 : 2000 - Identical

ISO/TS 15843 : 2000 - Identical

ISO/TS 15843:2000 - Identical