The Bioburden samples should be tested in the media types and incubation conditions as defined in ISO 11737-1, Sterilization of Healthcare products–Microbiological methods Part 1: Determination of the population of microorganisms on product.

The conditions defining the different medias, incubation times, temperatures, are defined in Annex A, section A.6.1.3, all of which are different based upon the nature of raw materials, method of manufacture, and conditions under which manufacturing occurs. Also please note that the bioburden method must be validated as well. The validation method is described also in Annex A, section A.7.

The ISO 11737-1 document can be purchased at www.aami.org.