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BS EN 556

1995 Edition, March 15, 1995

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Sterilization of Medical Devices - Requirements for Terminally- Sterilized Devices to Be Labelled 'Sterile'

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Superseded By: BS EN 556-1

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W/D S/S BY BS EN 556-1
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Description / Abstract:

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.

This European Standard is not applicable to in vitro diagnostic medical devices.