Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

Due to the great interest surrounding nanomaterials, the fights around a possible definition (mainly regarding the scale of these particles), and the recent evaluation of the antimicrobial action of silver nanoparticles, I find interesting this press release from DG Sanco.

Today, the European Commission and its non-food Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), have launched a public consultation on the preliminary opinion ‘Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’.

The consultation will run until 03 October 2014. Interested parties are invited to provide comments on the scientific evidence of this preliminary opinion online:

Here you can find the preliminary opinion:

The aim of the opinion is to address the use of nanomaterials in medical devices and to provide information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. According to the EU Recommendation for the definition of a nanomaterial ( Commission Recommendation 2011/969/EU, EC 2011) any particulate substance with at least one dimension in the size range between 1 and 100 nm is considered a nanomaterial. These particles (nanoparticles) exhibit specific characteristics that differ from the characteristics of larger sized particles with the same chemical composition.

This Guidance is aimed at providing information to help with safety evaluation and risk assessment on the use of nanomaterials in medical devices and it should be considered in conjunction with the ISO 10993-1:2009 standard ‘Biological evaluation of medical devices’. The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials, in view of the possible distinct properties, interactions, and effects that may differ from conventional forms of the same materials.

For the risk evaluation of the use of nanomaterials in medical devices, the SCENIHR recommends a phased approach based on potential release and characteristics of the nanomaterials.

For more information on the work of the Commission’s independent scientific committees:

(Source: DG Sanco)


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