Chemical-physical analyses | Tests for medical devices & cosmetics)

This part of ISO 17294 specifies a method for the determination of the elements aluminium, antimony, arsenic, barium, beryllium, bismuth, boron, cadmium, cesium, calcium, cerium, chromium, cobalt, copper, dysprosium, erbium, gadolinium, gallium, germanium, gold, hafnium, holmium, indium, iridium, iron, lanthanum, lead, lithium, lutetium, magnesium, manganese, mercury, molybdenum, neodymium, nickel, palladium, phosphorus, platinum, potassium, praseodymium, rubidium, rhenium, rhodium, ruthenium, samarium, scandium, selenium, silver, sodium, strontium, terbium, tellurium, thorium, thallium, thulium, tin, tungsten, uranium and its isotopes, vanadium, yttrium, ytterbium, zinc and zirconium in water and aqueous/acidic solutions.

Our laboratory equipment for this method: ICP-MS

The total organic carbon (TOC) is a measure of the carbon content of dissolved and undissolved organic substances in water and aqueous solutions or extracts.

Our laboratory equipment for this method: TOC

This method describes the determination of ethylene oxide (EO) and ethylene chlorohydrin (residual-ECH) in individual medical devices sterilized with EO by gas chromatography in combination with static head space analysis.

Our laboratory equipment for this method: GC-FID 1, GC-FID 2, GC-MS 1, GC-MS 2

This part of ISO 10993 describes general principles for the systematic assessment of possible and observed biodegradation processes in medical devices and for the planning and conduct of biodegradation studies. Information resulting from these studies can be used for the biological assessment described in the ISO 10993 series of standards. This part of ISO 10993 considers both non-absorbable and absorbable materials.

Our laboratory equipment for this method: GC-FID 1, GC-FID 2, GC-MS 1, GC-MS 2, HPLC 1, HPLC 2, HPLC 3

This part of ISO 10993 lays down general requirements for the design and layout of tests in a simulated environment for the identification and quantification of degradation products from finished plastic medical devices as used in clinical settings.

Our laboratory equipment for this method: GC-FID 1, GC-FID 2, GC-MS 1, GC-MS 2, HPLC 1, HPLC 2, HPLC 3

This part of ISO 17294 specifies a method for the determination of the elements aluminium, antimony, arsenic, barium, beryllium, bismuth, boron, cadmium, cesium, calcium, cerium, chromium, cobalt, copper, dysprosium, erbium, gadolinium, gallium, germanium, gold, hafnium, holmium, indium, iridium, iron, lanthanum, lead, lithium, lutetium, magnesium, manganese, mercury, molybdenum, neodymium, nickel, palladium, phosphorus, platinum, potassium, praseodymium, rubidium, rhenium, rhodium, ruthenium, samarium, scandium, selenium, silver, sodium, strontium, terbium, tellurium, thorium, thallium, thulium, tin, tungsten, uranium and its isotopes, vanadium, yttrium, ytterbium, zinc and zirconium in water and aqueous/acidic solutions.

Our laboratory equipment for this method: ICP-MS

This part of ISO 10993 describes a framework for the identification of a material and the qualitative and quantitative determination of its chemical constituents.

Our laboratory equipment for this method: GC-FID 1, GC-FID 2, GC-MS 1, GC-MS 2, HPLC 1, HPLC 2, HPLC 3