Engineering plastics â The Manual - F.wood-supply.dk
Engineering plastics â The Manual - F.wood-supply.dk
Engineering plastics â The Manual - F.wood-supply.dk
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Medical technology approvals<br />
<strong>The</strong> biocompatibility of a material is a prerequisite for its<br />
use in medical applications with direct tissue contact, such<br />
as short-term implants, medical appliances or medicines.<br />
Biocompatibility is the attribute used for materials or assemblies<br />
which initiate no toxic or allergic reactions in the<br />
human body.<br />
Ensinger materials suitable for medical applications (MT<br />
products) comply with requirements relating to direct contact<br />
with human tissue over a period of up to 24 hours. Special<br />
materials are also approved for longer contact periods.<br />
Ensinger offers biocompatible high-performance <strong>plastics</strong><br />
for medical applications in a wide variety of colours.<br />
By definition, plastic semi-finished products are not medical<br />
products or pharmaceutical products, but only an input<br />
material used in their production. As there is consequently<br />
no standardized stipulation of assessment of the biological<br />
suitability of semi-finished products, Ensinger has made its<br />
own selection from the wide spectrum of different biocompatibility<br />
tests contained in ISO 10993 and USP. This is intended<br />
to offer our customers the greatest possible support<br />
with the approval process for their medical or pharmaceutical<br />
end products. For this reason, Ensinger subjects stocked<br />
medical technology semi-finished products suitable for use<br />
as medical products with a contact period of
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