RO
SR EN 556-1:2003
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
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.
Status :
Withdrawn
Approval date : 6/23/2003
Publish date : 6/24/2003
Withdrawal date : 1/31/2025
Number of pages : 12
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Replaces SR EN 556:2001
- Normative reference SR EN ISO 13485:2003
- Normative reference SR EN ISO 13488:2002
- Replaced by SR EN 556-1:2025
- Amended by SR EN 556-1:2003/AC:2007