ISO/TS 15843:2000废止
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：International Organization for Standardization
专家解读视频
Approaches to the selection and auditing of a sterilization dose that economize in relation to the number of product untis required while maintaining assurance of attaining the desired ster sterility assurance level (SAL) are described in this standard. These approaches address: a) sampling plans for verification dose experiments and sterilization dose audits, b) establishing and maintaining product families for the selection and auditing of a sterilization dose, and c) frequency of sterilization dose audits. NOTE: Notification of the method of dose selection described in the 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.
NEN NVN ISO/TS 15843 : 2000 - Identical
AAMI ISO TIR 15843 : 2000 - Identical
AAMI ISO TIR 15843 : 2000 - Identical
NEN NVN ISO/TS 15843 : 2000 - Identical
NEN NVN ISO/TS 15843:2000 - Identical
AAMI ISO TIR 15843:2000 - Identical
