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ISO/TS 15843:2000廢止

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

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基本信息
標(biāo)準(zhǔn)編號(hào)： ISO/TS 15843:2000
發(fā)布時(shí)間：2000/9/28 0:00:00
標(biāo)準(zhǔn)類(lèi)別：TechnicalSpecification
出版單位：International Organization for Standardization
標(biāo)準(zhǔn)頁(yè)數(shù)：25
標(biāo)準(zhǔn)簡(jiǎn)介

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.

等同采用的國(guó)際標(biāo)準(zhǔn)

NEN NVN ISO/TS 15843 : 2000 - Identical

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

AAMI ISO TIR 15843:2000 - Identical