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Biocompatibility: ISO 10993

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

And also:

  • 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

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