SCENIHR has published its guidance on the risk assessment of medical devices containing nanomaterials in the context of the general framework for the biological evaluation of medical devices (described in the ISO 10993-1:2009 standard). The document highlights the potential for nanomaterials to exhibit properties and effects that may differ from conventional (non-nano) forms, so adaptation of existing test methods may be necessary.

European Commission. Scientific Committee on Emerging and Newly Identified Health Risks. Opinion on guidance on the determination of potential health effects of nanomaterials used in medical devices. SCENIHR adopted this opinion by written procedure on 6 January 2015. http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_045.pdf

 

The above items were taken from the January/February 2015 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

 

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