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prSSH EN ISO 17665:2024

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)

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)

General information

40.20     10 shk 2025

40.60    7 maj 2025

DPS

DPS/KT 316

European Norm

11.080.01  

Scope

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.

Related directives

Directives related to this standards.

Life cycle

PREVIOUSLY

PUBLISHED
DS CEN ISO/TS 17665-2:2009

PUBLISHED
SSH EN ISO 17665-1:2006

NOW

IN_DEVELOPMENT
prSSH EN ISO 17665:2024
40.20 DIS ballot initiated: 12 weeks
10 shk 2025

Related project

Adopted from EN ISO 17665:2024 IDENTICAL

Adopted from ISO 17665:2024 IDENTICAL

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