Elemental Analysis

1. Biological Effect: Physical and/or Chemical information
2. Turnaround time: 8 weeks
3. Sample Requirements:

ISO

120 cm² (test item < 0.5 mm thick);
60 cm² (test item ≥ 0.5 mm thick);
5 grams;
15 ml;
at least 1 test item;

4. Vehicle: polar

ISO 10993-18

The purpose of the study is to determine the amount and types of metallic elements present in the medical device or extract of the medical device. An extraction is performed according to ISO 10993-12 and ISO 10993-18. Extracts are mineralized using concentrated Nitric Acid to eliminate interference. Final solution is analyzed by inductively-coupled-plasma spectroscopy using a mass spectrometer as detector (ICP-MS).

The following metals are measured in a standard test (according to ICH Q3D(R1) Guideline):

Cd, Pb, As, Hg, Co, Ni, Tl, Se, Ag, Li, Ba, Cu, Cr, V, Au, Pd, Ir, Os, Ru, Pt, Mo, Sn