Tests within the validation of the instructions for sterilization of medical devices
(as per DIN EN ISO 17665-1)
In the same way as with reprocessing of medical devices (cleaning and disinfection) the distributor must describe a suitable sterilization method if the medical device is designated for sterilization.
To achieve the required sterility safety level the medical device manufacturer must indicate at least one validated sterilization method which meets the requirements of an international standard wherever possible, e.g. damp heat (DIN EN ISO 17665-1).
To verify the suitability of the steam sterilization procedure specified in the instructions, the sterile product is inoculated with spores of the very heat-resistant bacterium Geobacillus stearothermophilus.
The inoculated product is packaged according to the specifications (primary and possibly secondary packaging) and then steam sterilized using the specified parameters.
The steam sterilization is performed in a half-cycle process (e.g. 134°C, 2.5 minutes). The success of sterilization is then tested by inserting the product in a liquid culture medium for 7 days. The culture medium must not show any signs of bacteria growth, i.e. it must not be clouded.
Test procedure
| Contamination | Inoculation of the product with spores of Geobacillus stea-rothermophilus, areas of the product which are difficult to access by the steam must be afforded particular attention |
|---|---|
| Sterilization | Steam sterilization of the product as per specifications of the manufacturer (in half-cycle process) |
| Assessment of sterilization | Examination of the sterility using incubation of the product in a liquid culture medium for 7 days -> there must be no visible growth of microorganism |
Further Information
These tests are part of our accreditation, detailed information on the scope of accreditation can be found here.
You can also find detailed information on test procedures and test standards in our Information desk.
If you have any questions, the employees from our sales team will be happy to help you.
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