EN 556-1:2001

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices EN 556-1:2001

Publication date:   Jan 22, 2004

General information

90.92 Standard to be revised   Jun 5, 2022

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 a terminally-sterilized medical device to be designated 'STERILE'. Part 2 of 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), designation of a medical device as 'STERILE' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 556:1994 + A1:1998

NOW

PUBLISHED
EN 556-1:2001
90.92 Standard to be revised
Jun 5, 2022

CORRIGENDA / AMENDMENTS

PUBLISHED
EN 556-1:2001/AC:2006

REVISED BY

IN_DEVELOPMENT
EN 556-1:2024