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EN 556:1994

Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile" EN 556:1994

Publication date:   Jun 19, 2000

General information

99.60 Withdrawal effective   Aug 19, 1998

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080   Sterilization and disinfection

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Scope

1.1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled 'Sterile'. Note: For the purpose of the EC Directives for medical devices and for active implantable medical devices (see annex A), labelling a medical device 'Sterile' is only permissible when a validated sterilization process has been used. Requirements for the validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552 and EN 554. 1.2 This European Standard is not applicable to in vitro diagnostic medical devices.

Related legislation

Legislation related to this standard

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

NOW

WITHDRAWN
EN 556:1994
99.60 Withdrawal effective
Aug 19, 1998

REVISED BY

WITHDRAWN
EN 556:1994 + A1:1998