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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)

Sep 29, 2023

General information

60.60     Sep 29, 2023

DPS

DPS/KT 205

European Norm

11.080.01  

English  

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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.

Related directives

Directives related to this standards.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized
Directive 2017/745
2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonized
Directive 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN ISO 25424:2019

NOW

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

Related project

Adopted from EN ISO 25424:2019/A1:2022 IDENTICAL