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EN 556-2:2015

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

Publication date:   Dec 15, 2015

General information

99.60 Withdrawal effective   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 European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 556-2:2003

NOW

WITHDRAWN
EN 556-2:2015
99.60 Withdrawal effective
Nov 6, 2024

REVISED BY

PUBLISHED
EN 556-2:2024