Medical Application Policy

ICP DAS is a dedicated ISO13485:2016 certified manufacturer of medical grade TPU. We pay a high attention to consistency in terms of formulation as well as manufacturing process by maintaining the highest quality operational controls including change management system to ensure our commitment to meet and exceed our customers’ expectations. ICP DAS medical grade TPUs have also been tested for biocompatibility conforming to standards such as ISO10993 and USP Class VI (Biological Safety Statement available upon request).

The biocompatibility testing referenced above are only performed on ICP DAS TPU pellets and therefore make no representations regarding the suitability for use in any particular medical application. This Policy is intended to provide guidelines on whether ICP DAS supports the use of its products in customers’ proposed medical applications requested through our Medical Application Screening Form.

In reference to use of ISO 10993-1:2018 guidelines (Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process) on medical device categorization by contact duration, ICP DAS categorizes medical applications into the following three (3) categories:

• Category A (Limited Contact): Medical applications involving limited or transient contact (i.e., less than or equal to 24 hours) with a patient’s skin, body fluids or tissues.
• Category B (Prolonged Contact): Medical applications involving prolonged contact (i.e., greater than 24 hours to 30 days) with a patient’s skin, body fluids or tissues.

ICP DAS may support the use of ICP DAS medical grade TPU for Category A and Category B applications and will use its best business judgment to ensure specific corporate risk management conditions are met when supplying the materials.

• Category C (Permanent Contact): Medical applications involving permanent or long term contact (i.e., more than 30 days) with a patient’s skin, body fluids, or tissues.

ICP DAS will not knowingly or implicitly support the use of ICP DAS medical grade TPU into any developmental or commercial component or product that is intended for Category C applications.

While ICP DAS medical grade TPU pellets have been determined to be compliant with certain biocompatibility tests, ICP DAS makes no representations or warranties and accepts no responsibility, express or implied, concerning the suitability, safety or efficacy of any warning on losses or damages that may result from the use of ICP DAS medical grade TPU for any particular intermediate components or final products in medical applications. Any decision to determine any type of suitability (including biocompatibility) of ICP DAS medical grade TPU for its end use in any medical device applications should be solely based on the judgment of the manufacturer by conducting all necessary tests and evaluation under actual end-use requirements.

Customers, distributors, or resellers shall neither use ICP DAS product names, trademarks and the ICP DAS name nor represent others that ICP DAS permits, recommends, or endorses the use of its products in any medical application.

ICP DAS reserves the right to discourage their use of ICP DAS medical grade TPU if any identified or suspected act of non-compliance is discovered within the scope of this Policy.

Revision date: 2-Aug-2021