Microbiological Testing - Bioburden and Identification of Micro-Organisms

I

ISO MAN

Micrbiological Testings

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
 
C

CNSue

ISO 10993 or EN 30993

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

Starting to get Involved
Bioburden Testing

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:

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

Ilya
 
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