Microbiological Testing - Bioburden and Identification of Micro-Organisms

[ISO MAN]

Dear All,
I am looking for practical easy to use test methods for:

1. Bioburden of the finished product (Est. size is 250 gm and 6m length) for the
whole product and not only fluid bath,
2. Identification of micro-organisms on settle plates

Thanks

[CNSue]

Hi,

it depends on your application. The minimum requirements for plates (electrodes) are defined in ISO 10993-5 (biocompatibility): cytotoxicity and ISO 10993-10: dermal irritation and sensitization.

But, as mentioned before, it depends on the indented use.

Chris

[burovoy]

Hi

IMO, the bioburden testing methods are specified in

ANSI/AAMI/ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products

It's possible to look up the overview of the testing methods at:

http://www.nelsonlabs.com/bioburden/methods.htm

Ilya