Biocompatibility

The main reason for assessing the biocompatibility of a medical device or material is to protect the patient from possible biological risks.

For this reason, medical devices are usually subject to biocompatibility testing to investigate interactions with the patient’s tissues, cells or body fluids.

The biocompatibility testing of medical devices and materials is governed by the ISO 10993 series of standards. The test procedures specified in ISO 10993 provide detail on requirements and test methods. The test procedures offer a model that can be used to plan the appropriate steps for biological assessment and biocompatibility testing.

The specific tests required depends on the type of medical device, the material, the intended use and the nature and duration of contact with the human body. The standard distinguishes between in vitro, in vivo and chemical or physical tests.

The following parts of the standard are commonly referred to when assessing the biological effects of medical devices or materials on the human body by means of chemical characterisation:

Sample preparation and refernce materials ( ISO 10993-12)

• Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13)
• Identification and quantification of degradation products from ceramics (ISO 10993-14)
• Identification and quantification of degradation products from metals and alloys (ISO 10993-15)
• Establishment of allowable limits for leachable substances (ISO 10993-17)
• Chemical characterisation of materials (ISO 10993-18)

Chemical characterisation according
to ISO 10993-18

Here at Niutec AG, we offer the following chemical characterisation tests:

• Extractables and leachables
• Material properties
• Material comparisons
• Assessment of processing aids
• Studies on material changes, reprocessing and accelerated ageing

We also offer toxicological evaluations in cooperation with our specialised Partners.