“Biocompatible” refers to material or product having no negative effects on organisms in their immediate environment whether through chemical, biological, or physical interactions. This is particularly important for products in the healthcare sector such as medical devices contacting or inserted into the human body. This is the only way to ensure the product meets the necessary performance and safety requirements sustainably.
To ensure a product and its intended use do not harm the human body a biological evaluation of materials used must be carried out as part of the product development and thus the regulatory required proof of biocompatibility must be provided. The central parameters for testing and evaluation include:
- Risk potential of the material/product used, considering various processes in the product life cycle such as manufacturing, sterilisation methods, packaging, and possible reprocessing.
- Type and duration of contact of the material / product used.
- ...
For this purpose, a biocompatibility assessment is carried out according to the ISO 10993 series of standards (biological evaluation of medical devices) consisting of 23 parts covering testing and certification.
We are happy to offer our support in this area. Our experts have the necessary expertise and experience to help you meet the required biocompatibility requirements in your cases.
