RO
SR EN 556:2001
Sterilization of medical devices. Requirements for medical devices to be labelled "Sterile"
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.
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Status :
Withdrawn
Approval date : 4/30/2001
Publish date : 5/1/2001
Withdrawal date : 6/23/2003
Number of pages : 10
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Normative reference SR EN 46001:2000
- Normative reference SR EN 46002:2000
- Replaced by SR EN 556-1:2003