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Hi Jay
The title of EN 556 is: Sterilization of medical devices - Requirements for medical devices to be labeled "Sterile".
Despite the numerous sterilization processes available, one thing is common within Europe, ISO and all national Recommendations: for a medical device to be labeled as sterile, it must meet the requirements of EN 556. This harmonized standard specifies that the device's minimum sterility assurance level (SAL) is one in a million. There are multiple methods of achieving the required SAL and each is reviewed on a case-by-case basis.
All in all the requirements include: a) functional and physical design criteria for sterilization areas; b) staff qualifications, education, and other personnel consideration; processing procedures; d) installation, care, and maintenance of steam sterilizers: and e) quality control. See the explanation about the SAL given from Hug O'Connor in Answer 137.
Read the BASICS "What is Sterilization?" in the Central Service Journal 4/02, cont. 5/02 written by Peter Hooper.
And of course get a copy of EN 556, Sterilization of medical device and/or ISO 13683 Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities.
Kind regards
Josy Holdener
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