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ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation.

ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation.
The long-awaited ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation has been finally published!
 
Irritation tests of medical devices were taken out from ISO 10993-10, and now are fully described in dedicated ISO 10993-23 – many changes have been introduced…
 
This documents describes a stepwise approach for irritation testing of medical device. Furthermore, a new in vitro alternative test using Reconstituted human Epidermis was described.
 
Are you looking for gap analysis of your irritation tests? Or maybe you need your device to be complied with the latest ISO 10993-23?
 
Just contact us – we are ready to test medical devices in accordance to the latest ISO 10993-23!

Konmex BioLabs is ISO 17025 accredited!

By the decision of the Polish Accreditation Center (PCA), we obtained ISO 17025 accreditation! From this moment, Konmex BioLabs is ISO 17025 accredited with the accreditation number AB 1763.

The main purpose of implementing the ISO 17025 system is to improve the quality of tests and measurements performed. The requirements of the ISO 17025 system are intended mainly for testing and calibration laboratories in order to confirm their competence in the field of testing, measurement and calibration.

In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited.
Konmex BioLabs is Good Laboratory Practice (GLP) certified and ISO 17025 accredited!