Classifying a material as a nanomaterial (NM) requires at least 50 % of the particles have one or more external dimensions (size) between 1 nm and 100 nm. The experimental determinations of particle size and the particle number fraction are essential elements for assessing a material against the criteria in the EC NM definition.
EU jurisdiction explicitly addresses nanomaterials and contains regulatory definitions of the term ‘nanomaterial’. For example, in the Biocidal Products Regulation (EU) No 528/2012; the Medical Devices Regulation (EU) 2017/745; and the annexes of the Chemicals Regulation REACH (EC) No. 1907/2006, all of which were amended in 2018 to address nanomaterials.
SAXOCON provides you with everything you need to document compliance with regulatory requirements, including:
- Identification of nanomaterials through measurements
- Assessment of particulate materials
- The selection of appropriate laboratory facilities and equipment for detailed characterisation according to the EC’s recommendation on the definition of nanomaterials
- Documentation and presentation of results
- A toxicological risk assessment of results
Why choose us?
SAXOCON analytical services for nanomaterials give you access to:
- Extensive expertise in the measurement and characterisation of nanomaterials
- A multidisciplinary team of highly skilled scientists and experts
- High-level experience with state-of-the-art toxicological evaluations according to international standards
SAXOCON compiles all necessary results and toxicological documentation to help you ensure compliance with all relevant regulations.
Air quality investigation
Identify and trace Ultra Fine Particles in your air.
PMT characterisation of medical devices.
Identify and trace unwanted inorganic elements.
Test for Particulate Contamination
Identify unwanted particulates on your medical devices.