Abstract

This document provides requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. Moist heat sterilization processes covered by this document include but are not limited to: a) Saturated steam sterilization in which air is removed by venting; b) Saturated steam sterilization in which air is removed by active air removal; c) Contained product sterilization in which heat transfer is achieved by steam-air mixtures; d) Contained product sterilization in which heat transfer is achieved by water sprays. e) Contained product sterilization in which heat transfer is achieved by water immersion.

Begin

2016-03-02

WI

00204079

Planned document number

DIN EN ISO 17665

Project number

06301798

Responsible national committee

NA 176-03-09 AA - Sterilization and processing of medical devices  

Responsible european committee

CEN/TC 204 - Sterilization of medical devices  

Responsible international committee

ISO/TC 198/WG 3 - Moist heat sterilization  

draft standard

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022
2022-11
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previous edition(s)

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009); German version CEN ISO/TS 17665-2:2009
2009-07

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Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006
2006-11

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