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EN 556-2:2024

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

Publication date:   Jan 20, 2025

General information

60.60   Standard published   Nov 6, 2024

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

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

Related legislation

Legislation related to this standard

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

Harmonised Standard / Cited in the Official Journal
Legislation 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

Harmonised Standard / Cited in the Official Journal
Legislation 2017/745

Life cycle

PREVIOUSLY

WITHDRAWN
EN 556-2:2015

NOW

PUBLISHED
EN 556-2:2024
60.60 Standard published
Nov 6, 2024