SSH EN ISO 25424:2019/A1:2022

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)

Publication date: Sep 29, 2023

General information

Current stage: 60.60 Effective date: Sep 29, 2023

Originator: DPS

Owner: DPS/KT 205

Type: European Norm

ICS: 11.080.01

Languages: English

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Status: Published

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Scope

1.1 Inclusions 1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.

Life cycle

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PUBLISHED
SSH EN ISO 25424:2019/A1:2022
60.60 Standard published
Sep 29, 2023