Colours & masterbatch | materials


available in quantities as low as 1lb (453g). MediBatch concentrates are


formulated using FDA listed colour additives and a universal carrier that is compatible for blending with a wide range of polymers. Twelve standard concen- trates, including green, red, yellow, blue, violet, black and white, are available from stock in 1, 5 and 10lb quantities. Custom coloured concentrates, as well as pre-coloured compounds, are also available on a made to order basis. In order to get a device on the market, medical


device manufacturers must demonstrate to the Food and Drug Administration (FDA) or other regulatory body that a device is safe and effective for the intended use. If the device directly or indirectly contacts human tissue or fluids, the regulatory approval process may include biocompatibility testing of the device as prescribed by the International Standard ISO-10993. Device manufac- turers often prefer to use materials that are also tested and compliant to the relevant ISO-10993 tests. For


coloured plastic components, this includes the polymer and additives including pigments. “Masterbatch colour concentrates using medical device pigments should utilize polymer carriers that are


compatible with commonly used medical polymers, such as polyamides and thermo- plastic polyurethanes,” says Lawrence Acquaru- lo, CEO of Foster Corp.


Click on the links for more information: ❙ www.silvergate.co.uk ❙ www.colloids.co.uk ❙ www.albis.com ❙ www.teknorapex.com/teknor-color ❙ www.broadwaycolours.com ❙ www.ampacet.com ❙ www.clariant.com/masterbatches ❙ www.riverdaleglobal.com ❙ www.polyone.com ❙ www.af-color.com ❙ www.fostercomp.com


Left: Foster Corporation has launched MediBatch colour master- batches using FDA listed colour additives


”POLYFILL PP HC - used in sun visor frames in premium Class cars!”


Mattias Persson Sales manager


polykemi@polykemi.se | www.polykemi.com


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