Tema de trabajo aprobado
ISO/AWI TS 25462
Sterilization of health care products — Ethylene oxide — Guidance on the validation and routine processing of sterilization processes using alternative approach to parametric release
Reference number
ISO/AWI TS 25462
ISO/AWI TS 25462
Edition 1
© ISO 2025
Tema de trabajo aprobado
Resumen
This document provides guidance on an alternative approach to parametric release which would be supplemental to the method described in the requirements of ISO 11135:2014 that apply when parametric release is used to release the product after exposure to the ethylene oxide sterilization process It provides a path for transition of existing ethylene oxide sterilization cycles, as well as a path for the development and implementation of a parametric release specification for a new ethylene oxide sterilization cycle. Additionally, it highlights the advantages/disadvantages of this method versus the existing ISO 11135 requirements and the application of risk assessment.
Informaciones generales
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Estado: En desarrolloEtapa: Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
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Edición: 1
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Comité Técnico :ISO/TC 198
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