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 Validation approach


Towards a harmonised validation guideline

Given the rapid progress in the development of next generation nanoparticles as well as of respective analytical techniques and instruments the standardisation of measurement methods may not always be the most suitable and up-to-date approach. Therefore, NanoLyse proposes to work also on the standardisation of the quality of analytical results. This can best be achieved via harmonised validation guidelines for respective methods. This will assure a high level of reliability of the results obtained with methods validated according to the guidelines. The NanoLyse validation approach should be seen as the starting point towards harmonised validation guidelines for nanoparticle analysis. In an iterative process this first document will be further developed upon the experiences gained in the NanoLyse project as well as by taking into account the experience of the broader nano-analytical community. To this end, we invite comments and suggestions to further refine the present version.

Validation of methods for the detection and quantification of engineered nanoparticles in food

The potential impact of nanomaterials on the environment and on human health has already triggered legislation requiring labelling of products containing nanoparticles. However, so far, no validated analytical methods for the implementation of this legislation exist. This paper outlines a generic approach for the validation of methods for detection and quantification of nanoparticles in food samples. It proposes validation of identity, selectivity, precision, working range, limit of detection and robustness, bearing in mind that each "result" must include information about the chemical identity, particle size and mass or particle number concentration. This has an impact on testing for selectivity and trueness, which also must take these aspects into consideration. Selectivity must not only be tested against matrix constituents and other nanoparticles, but it shall also be tested whether the methods apply equally well to particles of different suppliers. In trueness testing, information whether the particle size distribution has changed during analysis is required. Results are largely expected to follow normal distributions due to the expected high number of particles. An approach of estimating measurement uncertainties from the validation data is given.


Paper:  Validation of methods for the detection and quantification of engineered nanoparticles in food

Project Deliverable: Protocol for a common, robust method validation approach for ENP in food

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