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SCENIHR 2015: Guidance on the determination of potential health effects of nanomaterials in medical devices

EC_200In January 2015, the EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) adopted an Opinion on the "Guidance on the determination of potential health effects of nanomaterials used in medical devices". 

This Guidance addresses the use of nanomaterials in medical devices and provides information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials.

Specifically, guidance is provided on physico-chemical characterisation of nanomaterials, the determination of hazards associated with the use of nanomaterials, and risk assessment for the use of nanomaterials in medical devices.

A phased approach is recommended for evaluating the risk of the use of nanomaterials in medical devices based on potential release and characteristics of the nanomaterials to avoid unnecessary testing.

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1 second is the time resolution at which SAFENANO can characterise an aerosol emission.