Unless Arkema otherwise expressly agrees by written contract, the Arkema trademarks and the Arkema name shall not be used in conjunction with customers' ,medical devices, including without limitation, permanent or temporary implantable devices, and customers shall not represent to anyone else, that Arkema allows, endorses, or permits the use of Arkema products for such medical devices. Further, all implantable medical devices, whether permanent or temporary, carry a risk of adverse consequences. With respect to implantable medical devices, you should not rely upon the judgement of Arkema. Any decision regarding the appropriateness of a particular medical device in a particular medical application or for a specific clinical use should be based upon the judgement of your physician, medical device supplier and the United States Food and Drug Administration. Unless otherwise specifically stated by Arkema in writing, Arkema does not perform clinical medical studies on implantable medical devices. Arkema cannot weigh the benefits against the risks of a device and does not offer a medical judgement on the safety or efficacy of use of any Arkema product in a medical device.
Further, biocompatibility testing of Arkema products related to USP Class VI and certain requirements of ISO standard 10993-1 cannot assure the biocompatibility of final or intermediate products made from Arkema products or suitability of such products for their use in medical applications i.e. the test data cannot be used to conclude that any medical devices manufactured from Arkema products meet the requirements of USP Class VI and ISO standard 10993-1. It is the sole responsibility of the manufacturer of final end-use (and finished) products to conduct all necessary testing (including biocompatibility tests) and inspections and to evaluate under actual end-use requirements.
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