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SRPS EN 556-2:2025

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

Jan 31, 2025

General information

60.60     Jan 31, 2025

ISS

Z076

European Norm

11.080.01  

English  

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Scope

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

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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
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

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN 556-2:2016

NOW

PUBLISHED
SRPS EN 556-2:2025
60.60 Standard published
Jan 31, 2025

Related project

Adopted from EN 556-2:2024 IDENTICAL