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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
標(biāo)準(zhǔn)編號: AAMI ISO TIR 15843:2000
發(fā)布時間:2001/4/25 0:00:00
標(biāo)準(zhǔn)類別:Standard
出版單位:Association for Advancement of Medical Instrumentation
標(biāo)準(zhǔn)頁數(shù):21
標(biāo)準(zhǔn)簡介

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.

標(biāo)準(zhǔn)備注

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

本標(biāo)準(zhǔn)替代的舊標(biāo)準(zhǔn)

AAMI ST31:1990

AAMI ST32:1991

AAMI ST31 : 1990

AAMI ST32 : 1991

等同采用的國際標(biāo)準(zhǔn)

ISO/TS 15843:2000 - Identical

ISO/TS 15843 : 2000 - Identical

ISO/TS 15843 : 2000 - Identical