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ILNAS-EN ISO 17665:2024 Edition 05/2024
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
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  • 136.7 / copy
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Abstract

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 204 : Sterilization of medical devices

Implementation

start of the vote on the project    01/09/2022   date of ratification (dor)    03/12/2023
end of the vote on the project    24/11/2022   date of anouncement (doa)    31/08/2024
start of the vote on the final project    07/09/2023   date of publication (dop)    30/11/2024
end of the vote on the final project    02/11/2023   date of withdrawal (dow)    30/11/2024


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
CEN ISO/TS 17665-2:2009
ILNAS-EN ISO 17665-1:2006

Relations to international standards
ISO 17665 
ISO 17665:2024 

International Classification for Standards (ICS codes) :

11.080.01 : Sterilization and disinfection in general

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