Medical Devices

LAUS GmbHAuf der Schafweide 20, D-67489 Kirrweiler

Phone: +49 (0) 6321 - 96 299 - 0 · Fax: +49 (0) 6321 - 96 299 - 29info@laus.de · www.laus.de

Biological Evaluation according to ISO 10993

The evaluation of possible interactions and potential secondary effects of medical devices in contact with the human body is required by the regulatory authorities. Medical devices can be divided into different categories. Based on the contact and the contact time in the human body, the necessary tests can be determined for the biological evaluation of the medical device. Performing these analyses in a GLP accredited laboratory will ensure the complete conformity of the results with the requirements of the different parts of the ISO 10993 as well as other guidelines.

Together with our partner laboratories, we offer you the necessary tests for a biological evaluation of your medical device under the principles of Good Laboratory Practice (GLP) at LAUS and/or ISO 17025/Good Manufacturing Practice (GMP) at our partner laboratories as well as a risk assessment of your product:

Studies according ISO 10993:

ISO 10993-3: Genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-4: Selection of tests for interaction with blood ISO 10993-5: Tests for in vitro cytotoxicity ISO 10993-6: Tests for local effects after implantation ISO 10993-7: Ethylene oxide sterilization residuals ISO 10993-10: Tests for irritation and skin sensitization ISO 10993-11: Tests for systemic toxicity

Further studies:

ISO 11737-1: Bioburden USP 643/PharmEur.2.2.44: Measurement of total organic carbon (TOC)

The study you need is not listed? Please contact us.We will prepare you an individual offer for your needs.