DS/EN 556:1995
Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

Standard No.

DS/EN 556:1995

Release Date

1995

Published By

Danish Standards Foundation

Status

Withdraw

Latest

DS/EN 556:1995

Scope

1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled 'STERILE'. NOTE. For the purposes 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. 2 This European Standard is not applicable to in vitro diagnostic medical devices.

DS/EN 556:1995 history

• 1995 DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"