COMPLIANCE INFO_2020 - Laserfiche WebLink

Home Browse Search

ARk1 MA SAFETY DATA SHEET CERTINCOATO TC - 100 Coating Material Arkema has implemented a Medical Policy regarding the use of Arkema products in Medical Devices applications that are in contact with the body or circulating bodily fluids (http://www.arkema. com/en/social-responsibility/responsible-product-management/medical- device-policylndex.html) Arkema has designated Medical grades to be used for such Medical Device applications. Products that 1I have not been designated as Medical grades are not authorized by Arkema for use in Medical Device applications that are in contact with the body or circulating bodily fluids. In addition, Arkema strictly prohibits the use of any Arkema products in Medical Device applications that are implanted in the body or in contact with bodily fluids or tissues for greater than 30 days. 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 in such medical devices. It is the sole responsibility of the manufacturer of the medical device to determine the suitability (including biocompatibility) of all raw materials, products and components, including any medical grade Arkema products, in order to ensure that the final end-use product is safe for its end use; performs or functions as intended; and complies with all applicable legal and regulatory requirements (FDA or other national drug agencies) It is the sole responsibility of the manufacturer of the medical device to conduct all necessary tests and inspections and to evaluate the medical device under actual end-use requirements and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks and fulfill any postmarket surveillance obligations. Any decision regarding the appropriateness of a particular Arkema material in a particular medical device should be based on the judgment of the manufacturer, seller, the competent authority, and the treating physician. I Product code : RIB00 Version 3 . 2 Issued on : 07/ 18/2018 Page : 15 / 15 Page 15/ 16 Quick-FDS [19050-00814-08435-011984] " 2020-02-26 - 00: 13:35