
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

专家解读视频
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.
To be used in conjunction with AAMI ISO 11137 (07/2002) Supersedes AAMI ST31, AAMI ST32 and AAMI TIR5. (04/2004)
ISO/TS 15843 : 2000 - Identical
ISO/TS 15843 : 2000 - Identical
ISO/TS 15843:2000 - Identical