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奥升德医疗产品策略和规范

Ascend Performance Materials (Ascend) - Policy regarding Medical Device Applications of Ascend’s Products

Ascend seeks business relationships with customers who participate in the healthcare industry as a component supplier. As a matter of principal, our Medical Device Policy is that:

a) Ascend does not supply any products to be used in medical device applications that constitute a non-temporary implant (i.e., that, in whole or in part, may be in contact with a patient’s skin, body fluids or tissues for more than 29 days).

b) Ascend may supply products to be used in medical device applications where the medical device could be in contact with a patient’s skin, body fluids or tissues for a period of 29 days or less. Ascend only supplies customers with products for these types of medical devices in accordance with its medical contractual provisions, and where other specific corporate risk management conditions are met.

c) Ascend may supply products for use in all other medical device applications. Ascend will use its good business judgment to set specific Ascend corporate risk management conditions in such circumstances.

d) Ascend does not design, manufacture, test, and/or directly sell any medical devices. As a component supplier, Ascend may offer technical assistance to customers related to the performance and design using our materials only. If a medical device manufacturer chooses to use an Ascend component in a medical device, it remains the sole responsibility of the medical device manufacturer to test and validate the performance of their medical device for fitness in use and for compliance with all applicable medical device legal requirements. Ascend assumes no responsibility or liability for the medical device’s fitness in use or compliance with applicable medical device legal requirements.

e) Ascend has designated specific medical grade compositions for its products. Customers who intend to use Ascend products in a medical device application will only be supplied with these specific medical grade compositions. No other Ascend products may be supplied for use in medical device applications.

f) It is the sole responsibility of the manufacturer of the medical device to determine the suitability (including biocompatibility) of all new raw materials, products, and components, including any medical grade Ascend produces, 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.

g) 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 Ascend material in a particular medical device should be based on the judgment of the manufacturer, seller, the competent authority, and the treating healthcare professional.

h) Unless Ascend expressly agrees by written contract, Ascend product names, trademarks and the Ascend name shall not be used with any medical devices, and customers should not represent to others that Ascend permits, recommends, or endorses the use of its products in any medical devices.

i) ASCEND WILL NOT WARRANT THAT ITS PRODUCTS ARE SUITABLE FOR USE IN ANY MEDICAL DEVICE OR MEDICAL APPLICATION.

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