ISO 10993

What is ISO 10993?

The ISO 10993 – Biological Evaluation of Medical Devices – is a series of internationally recognized regulatory standard by the British Standard Institution (BSI). ISO 10993 entails 22 parts which provide comprehensive regulatory requirements to evaluate and control the biocompatibility of medical devices. According to BSI, biocompatibility is the “ability of a material to perform with an appropriate host response in a specific application”. Therefore, obtaining this ISO certification will provide trust and concrete validation that our product are indeed reliable for use.

Why is ISO 10993 important for our 3D printed filament and implants?

Our bioactive filament and 3D printed products will ultimately be implanted into the body for clinical use. Hence, it encompasses high-risks and is considered as a class III medical device. One of the components for OSSFILA to be approved for commercial use is to ensure that the implants is biocompatible and constitute no long-term biological risks. To fulfil the ISO 10993 requirements, it involves stringent test which can confidently prove that OSSFILA implants and filaments can integrate with the host without any long-term biological risks. OSSFILA is currently in preparation to be equip for the stringent test in order to initiate our ISO 10993 application.