CEN - EN 556-1
Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices
active, Most Current
| Organization: | CEN |
| Publication Date: | 1 October 2001 |
| Status: | active |
| Page Count: | 12 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
This European Standard specifies the requirements for a
terminally-sterilize
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.
Document History
EN 556-1
October 1, 2001
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...
October 1, 2001
Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices
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