EN 556-1:2001
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
- Standard No.
- EN 556-1:2001
- Release Date
- 2001
- Published By
- European Committee for Standardization (CEN)
- Latest
- EN 556-1:2001
- Scope
- This European Standard specifies the requirements for a terminally-sterilized medical device to bedesignated "STERILE". Part 2 of this European Standard specifies the requirements for an asepticallyprocessed medical device to be designated "STERILE".NOTE ForThe purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical deviceas "STERILE" is only permissible when a validated sterilization process has been applied. Requirements for validationand routine control of processes forThe sterilization of medical devices are specified in EN 550, EN 552, EN 554,EN ISO 14160 and EN ISO 14937.
EN 556-1:2001 history
- 2001 EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
