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EN 556-1:2001

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

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   Jul 3, 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 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
Legislation 98/79/EC
90/385/EEC

Active implantable medical devices

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

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 556:1994 + A1:1998

NOW

WITHDRAWN
EN 556-1:2001
99.60 Withdrawal effective
Jul 3, 2024

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN 556-1:2001/AC:2006

REVISED BY

PUBLISHED
EN 556-1:2024