MBST CE marking

Biocompatibility – Medical technology

In the production of medical devices, all materials that come into direct contact with the human body must be free of unwanted side effects for the patient and still be able to fulfil their function. Newly developed medical devices must therefore always be subjected to a biological assessment and a test of biocompatibility. The testing measures required depend on the type of medical device or material, the intended use and the kind and duration of contact with the human body.

For the MBST magnetic resonance therapy devices, only materials that are biocompatible are used for all surfaces that patients come into contact with.

Biocompatibility – Quality assurance

In medical context, materials are biocompatible if they do not have a negative influence on the metabolism of living tissues when these come into direct contact with them. The materials used in a medical device must not cause any harm to the human body. Any detachment of particles that may occur must not cause any reactions such as inflammation. On general: "A medical device must not cause any damage to the patient." According to the Medizinproduktegesetz, medical devices must be subjected to comprehensive testing before market placement in order to protect patients.

Tested biocompatibility for more patient security

Our medical MBST therapy devices shall not only fulfil their intended use, be easy to handle and to clean and last but not least visually appealing. Their surface properties must also meet the defined quality requirements. We consider not only the technical requirements of the materials used for our MBST magnetic resonance therapy systems, but also ensure that the material is compatible with the human organism. All materials that patients come into contact with during a MBST therapy are biocompatible and have a high chemical resistance to many commercially available disinfectants and cleaning agents.

Biological safety

Thanks to high-quality medical products, such as MBST magnetic resonance therapy devices, many people nowadays can experience an improved quality of their daily life. To achieve this, the therapy devices must function perfectly and reliably. Especially when it comes to direct contact with human tissue, the quality of the products is decisive for human well-being. All our materials used, which require a biocompatibility test, fulfil the requirements. The reports of biocompatibility are provided by MedTec in the registration process of every MBST magnetic resonance therapy device.

Ideal conditions for the international market launch

The biological safety of medical devices must be taken into account during both development and production. A test for biological safety is part of the conformity assessment procedure. Therefore, MedTec systematically implements the steps for proven biological safety in relation to risk management. Successful tests are an important step on the way to the CE marking of MBST magnetic resonance therapy devices.

MedTec ensures the consistent quality of the materials by regularly tests of relevant biocompatibility parameters.

REACH Conformity

Biocompatibility*

Enviroment Protection

Biocompatibility – Medical technology

Biocompatibility – Quality assurance

Tested biocompatibility for more patient security

Biological safety

Ideal conditions for the international market launch

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*Disclaimer/Patientinformation