It must be proven for the materials used with intended body contact that no biological hazards arise for users and third parties within the scope of their intended use (EN ISO 10993-1).
The biological compatibility that you have to prove starts with the contact classification and the chemical characterisation. Product- and application-specific tests and assessments are further steps to fully perform a biocompatibility assessment.
BEO BERLIN takes over the selection and evaluation steps for you and recommends the appropriate tests. We will be happy to research the necessary tests and appropriately accredited testing laboratories for you and also take care of the communication.
The preparation of the biocompatibility assessment report is an important part of the technical documentation. Do you need support with the implementation?
