This certification system is based on the European standard EN 16785-1 which allows an independent assessment of statements about the bio-based content of products. Bio-based content refers to biomass, not just bio-based carbon.
Why choose the biocompatible medical compound
Innovation is leading to increasingly effective surgical interventions and an increase in cutting-edge therapies for patients.
All this translates into greater attention to safety: the materials used in the medical field must be of high quality to guarantee the safety of patients and avoid post-operative complications.
Plastics in particular can contain unwanted substances, which originate at the time of production or due to external contamination.
An example is represented by SVHC derived from tin: declared reprotoxic, from 2024, they will no longer be permitted for use in medical applications.
For this reason, the entire sector is studying innovative, safe and biocompatible products.
What does biocompatibility consist of
A material can be considered biocompatible when it does not produce harmful effects on vital functions, does not cause allergic reactions or other pathologies.
The reference Certification is USP class VI (United States Pharmacopoeia): its high standards require that the raw materials used in medical devices are subjected to biological tests for risk assessment. Purity, therefore, must be maintained in all phases of the production process, with an environment free from contaminants (such as additives or other residues), as well as substances that may alter their properties.
The properties of our new biocompatible Medical Compound
Our attention to the health and safety of products, as well as the progressive elimination of old stabilizing agents, have led us to study an innovative system of non-toxic stabilizers intended for molding, certified “USP class VI”.
The advantages for those who decide to purchase it are many:
- Safety of materials and compliance with medical regulations
- Maintenance of the same stabilization performance as with historical products
- Maintenance of the same transparency of the finished product
- Maintenance of the same vicat of the finished product.
Solve the problem of banning old stabilizing agents in time!
In 2022, test the new material and obtain the new approval, adapting to the MDR 745 regulation.
The new compounds are available for both molding and extrusion and have the great advantage of being flexible up to 55 shore A, easy to work and to color. The most requested applications are in the design, fashion and construction sectors.
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