Healthcare Disclaimer
Although INEOS Styrolution has developed dedicated Healthcare & Diagnostics Products[1] in close cooperation with healthcare and/or pharmaceutical companies, INEOS Styrolution has not designed or tested its plastics with respect to the special requirements related to their use in medical devices (defined in Risk Classes I, II and III according to the European and US Medical Device legislation) and pharmaceutical applications. THEREFORE INEOS STYROLUTION MAKES NO WARRANTY OR REPRESENTATION OF ANY KIND, EXPRESS OR IMPLIED, REGARDING THE SUITABILITY OR FITNESS OF ANY INEOS STYROLUTION PRODUCT FOR USE IN ANY MEDICAL DEVICE AND/OR PHARMACEUTICAL APPLICATION AND INEOS STYROLUTION DISCLAIMS ALL LIABILITY IN CONNECTION THEREWITH. The customers, having the expertise and the knowledge in the intended use of an INEOS Styrolution product, have to establish, based on their own experience and tests, that the INEOS Styrolution product selected and specified by them for specific medical and/or pharmaceutical applications are safe and suitable for use in such applications including packaging of parenteral and ophthalmic products as well as inhalers. The customers have the sole responsibility to ensure that the medical device or pharmaceutical application manufactured using an INEOS Styrolution product is safe, lawful and technically suitable for the intended use and assume all risks and liabilities in connection therewith.
Moreover, please be aware that INEOS Styrolution does not supply its products for the manufacture of implants in any risk class and expressly advises against the use of its products for these medical applications.
[1] Specific Specialty products covered by the Full HD (Healthcare & Diagnostics) Service Package.