Chemical characterization according to ISO 10993-18 is an important part of the biological safety evaluation (ISO 10993 series) for certification of medical devices. Niutec AG has validated and accredited analytical methods for determining extractables and leachables. These analytical methods make it possible to cover a broad spectrum of substance classes.
During the manufacture of medical devices, various processing aids are used, some with imprecise composition specifications. Substances can remain on the surface of the products or even permeate them. Furthermore, a wide range of materials is used, which are chosen to suit the application of the medical device. Every material has a risk of releasing possible components due to its composition. Therefore, it must be ensured for each medical device that no residues of processing aids or no material components are dissolved or released in a toxicologically relevant quantity.
In order to be able to cover as many potential extractables and leachables as possible, the medical products have to be extracted into different solvents and the extract solution has to be analyzed further. The extraction parameters and solvent selection strongly depend on the application and composition of the medical device. Niutec AG has extensive knowledge in this area.
Our experts will be happy to develop a test strategy tailored to your product.
Procedure for extractables and leachables
- Development of a test strategy adapted to the application of your medical device, raw material or packaging
- Calculation of the threshold value AET (Analytical Estimation Threshold)
- Extraction methods according to ISO 10993-12, ISO 10993-15, ISO 10993 -18
- Gas Chromatography Mass Spectrometry GC-MS
- Head-Space-Gas Chromatography Mass Spectrometry HS-GC-MS
- Liquid Chromatography Mass Spectrometry LC-MS/MS
- Ion Chromatography IC
- Inductively Coupled Plasma Mass Spectrometry ICP-MS
- Fourier Transform Infrared Spectrometry FTIR
- Total Organic Carbon TOC
- Pragmatic identification procedure of unknown substances through internal databases, customised auxiliary materials, raw materials and derivations
- Independent toxicological evaluation of the identified substances with experts
Do not hesitate to contact us to discuss any questions you may have.