Expanding our accreditation scope

Since June 1, 2024 the state standard GOST ISO 10993-10-2011 "Medical devices. Evaluation of biological effect of medical devices. Part 10. Testing of irritant and sensitising action" was cancelled

Instead of it the state standard GOST ISO 10993-10-2023 "Medical devices. Evaluation of biological effect of medical devices. Part 10. Testing of sensitising action" and GOST ISO 10993-23-2023 "Medical devices. Evaluation of the biological effect of medical devices. Part 23. Testing of irritant action" were introduced.

In response to these changes, Simera-TK Testing Laboratory is currently undergoing the accreditation expansion process, which will now include:

GOST ISO 10993-23-2023 "Medical devices. Evaluation of biological effect of medical devices. Part 23. Testing of irritant action", effective date June 01, 2024.

We are pleased to announce that we have successfully completed the first stage of verification and are now proceeding to the second stage. We will provide updates on the completion of this process and make relevant documents available on our website.