BS-EN-556-1 › Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
The following bibliographic material is provided to assist you with your purchasing decision:
Included in this current edition are the following subparts:
AMD 16728 - Oct. 31, 2006
BS EN 556-1 is the standard that specifies the requirements for a terminally sterilized medical device to be designated “STERILE”.
Part 2 of BS EN 556 specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
Designation of a medical device as “STERILE” is only permissible when a validated sterilization process has been applied.
Medical equipment, Medical instruments, Sterile equipment, Sterilization (hygiene), Quality assurance, Quality control, Marking, Microorganisms
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in Paper format.
BS EN 556-1:2001
Dec. 11, 2001
BS EN 556:1995