The Bioburden test for tissue determines the total number of viable microorganisms in or on a tissue product or solution. It is performed on any tissue product that requires control and/or monitoring of bioburden counts, usually as part of a sterilization program. This test acts as an early warning system for possible production problems that could lead to inadequate sterilization or disinfection processing. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.
Find additional information on coordinated Quarterly Dose Audits (QDAs) and Radiation Sterilization.
Nelson Labs performs this test in accordance with ANSI/AAMI/ISO 11737-1 and is most commonly referenced in the Radiation Sterilization standards (ANSI/AAMI/ISO 11137-1 & 2) and the EO Sterilization standard (ANSI/AAMI/ISO 11135).
- ANSI/AAMI/ISO 11737
- ANSI/AAMI/ISO 11137
- ISO 11135
- EN 1174
- EN 13795