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prSSH EN 556-2:2024

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

General information

40.20     Feb 10, 2025

40.60    May 7, 2025

DPS

DPS/KT 316

European Norm

11.080.01  

Scope

This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.

Related directives

Directives related to this standards.

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

Directive 2017/746
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

Directive 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN 556-2:2015

NOW

IN_DEVELOPMENT
prSSH EN 556-2:2024
40.20 DIS ballot initiated: 12 weeks
Feb 10, 2025

Related project

Adopted from EN 556-2:2024 IDENTICAL

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