Medical Device Bioburden Testing | 合法醫療器材資訊網

TheBioburdentestdeterminesthetotalnumberofviablemicroorganismsinoronamedicaldevice,container,orcomponent.Itisperformedonanyproductthat​ ...

The Bioburden Test determines the total number of viable microorganisms in or on a medical device, container, or component. It is performed on any 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. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.

For additional information on coordinated quarterly dose audits (QDA), visit Radiation Sterilization[1].

Nelson Labs performs this test in accordance with ANSI/AAMI/ISO 11737-1 and is most commonly referenced in the Radiation Sterilization standards[2] (ANSI/AAMI/ISO 11137-1 & 2) and the EO Sterilization stan...