Konmex Laboratories provide services of medical devices biocompatibility testing in compliance with ISO 10993 “Biological evaluation of medical devices”.
Biocompatibility of a medical device
Biocompatibility of a medical device has to be evaluated in the view of the harmonized standard ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing”. The biological test methods applicable for respective medical devices are classified regarding their nature and duration of body contact.
We conduct the following standard biocompatibility tests:
- Cytotoxicity testing 10993-5
- Irritation / Intracutaneous reactivity testing 10993-10
- Sensitization testing 10993-10
- Systemic toxicity testing 10993-11
- Subchronic toxicity testing 10993-11
- Genotoxicity testing 10993-3
- Implantation testing 10993-6
- Haemocompatibility testing 10993-4
- Pyrogen (endotoxin) USP/EP and 10993-11
- Identification and quantification of degradation products from polymeric medical devices 10993-13
- Identification and quantification of degradation products from metals and alloys 10993-15
- Chemical characterization of materials 10993-18