BIORIMA focused on biomaterials in the nano range in accordance with the call on "Support for good governance in biomaterials research following the safe, integrated and responsible approach as laid down in "Nanosciences and Nanotechnologies: An action plan for Europe". BIORIMA had the following objectives:
1: Generate and store a bank of relevant reference and/or certified, well-characterised reference NBM – covering the classes: metal/metal oxide, ceramics, organics and hypbrids (see Table 1) - for use in BIORIMA and for future projects which produce NBM and need to have access to the reference BIORIMA NBM for comparative purpose. Support the standardisation of the production methods (e.g. large sample preparation/assessment) of the proposed NBM, including methods that will reflect their eventual deployment as part of ATMP and MD. Undertake a Life Cycle Analysis of the proposed NBM and perform an assessment of their potential exposure to humans and the environment.
2: Develop exposure assessment/monitoring systems, on the field detection systems as well as methods for their performance assessment; assess accidental risks including explosion and massive release of NBM. 3: Compare and validate current (and/or to develop including validation of new) test methods, including in vitro, in vivo methods, to detect adverse effects from NBM to:
• human health including acute and chronic toxicity (including oral, inhalation, dermal and intravenous injection);
• environment; ecotoxicity tests, persistence, bioaccumulation, toxicity and life cycle impacts on all forms of biota;
• integrate the Exposure and Hazard assessment into an overarching Intelligent Testing Strategy (ITS) compatible with the current evaluation/test guidance for biomaterials ISO-10993-1;
4: Develop (web-based) predictive models of the toxic behaviour of engineered NBM; To adapt, extend and validate a reliable thorough overarching methodology for tiered risk assessment for engineered NBM; generate different risk reduction strategies and systems and the BIORIMA IRM framework for evaluating and implementing them; develop a rationale for selecting the tools in objectives 1, 2 and 3 and use them to evaluate the risk profile of NBM – as demonstrated through case studies; integrate the BIORIMA tools into a web-based Decision Support System (DSS) available to all stakeholders (Academia, Industry, Patient organisation, regulatory bodies and Standardisation authorities).
