Disclaimer
For more information, please contact your local customer service or sales representative.
Please note that we do not routinely analyze additional substances that are not listed in the Safety Data Sheet (SDS). Unless otherwise indicated, the information provided herein is based upon information from raw material suppliers, product composition and knowledge of our manufacturing process. If a questionnaire was submitted, please note that to respond to each customer in a timely and efficient manner, our company has developed and will use a standardized system to store and provide the requested information.
See SDS for Health & Safety Considerations.
The regulatory statements, technical information, and all other information or recommendations contained herein are believed to be accurate as of the date hereof. All information is provided “as-is” and subject to change without notice. Since the conditions and methods of use of the product and certain information referred to herein are beyond our control, Arkema expressly disclaims any and all liability as to any results obtained or arising from any use of the product or reliance on such information, as such, it is the sole responsibility of the end-user to ensure that the final product is safe for its end use; performs or functions as intended; and complies with all applicable legal and regulatory requirements.
** NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED (INCLUDING SUITABILITY FOR USE IN ANY MEDICAL DEVICE OR MEDICAL APPLICATION), IS MADE CONCERNING THE PRODUCTS DESCRIBED OR THE INFORMATION PROVIDED HEREIN. **
The information provided herein relates only to the specific product designated and may not be applicable when such product is used in combination with other materials or in any process.
The performance of the product, its shelf life, and application characteristics depends on many variables, and changes in these variables can impact product performance. The user should thoroughly test the suitability of the product in advance for any intended use or application before commercialization. This is not a warranty, an agreement, or substitute for expert or professional advice. Nothing contained herein constitutes a license to practice under any patent and it should not be construed as an inducement to infringe any patent and the user is advised to take appropriate steps to be sure that any proposed use of the product will not result in patent infringement. It is the user responsibility to require an updated version of this document.
Arkema has implemented a Medical Policy regarding the use of Arkema products in Medical Devices applications.
Arkema has designated Medical grades to be used for such Medical Device applications. Products that 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 and/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 and/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. Arkema does not design, manufacture and/or sell any medical devices. Arkema does not co-design, or offer assistance to any purchaser of its products, in their design, manufacture and/or sale of products for 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 of 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 (U.S. Food and Drug Administration 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 product in a particular medical device should be based on the judgment of the manufacturer, seller, the competent authority, and the treating physician.
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