The application of TPU has been designated by leading manufacturers of medicines, health products, hospital equipment, biomedical equipment, and personal protective equipment (PPE) for medical personnel.
In many markets, TPU is favored for its high performance, especially in the field of healthcare. It has a wide range of applications, ranging from artificial heart components and plasma bags to isolation tents in hospitals.Its high strength, tear resistance and biocompatibility characteristics continue to stimulate the vitality of product innovation in the entire medical market.As new applications continue to emerge, especially medical equipment manufacturers are actively promoting the market expansion of available application types (such as isolation membranes or wound dressings).
Specifically, polyurethane is highly respected for its advantages in these harsh environments.In the medical environment, materials often need to rub or bend against each other.The lack of strengthening of TPU may cause these materials to be more prone to fatigue or decline in strength.Enhancing the performance of materials through TPU has become one of the important ways to promote product design and innovation.
With the development of the TPU industry year by year, its technical threshold is no longer a decisive obstacle in the medical field. The number of TPU suppliers that can meet medical requirements and have corresponding mass production capabilities is gradually increasing, but the mainstream medical TPU suppliers in the market are still relatively limited. The main "roadblock" is: certification standards.At present, the main certification standards are the following：
1.EU Regulation 2017/745 (MDR): According to the EU MDR regulation, all medical devices sold in the EU market need to meet new clinical evaluation requirements, including requirements for material biocompatibility, chemical composition, traceability, etc.As a material in medical equipment, TPU needs to go through a series of tests and evaluations to ensure that it meets the requirements of MDR, which may take time and resources.
2. ISO 10993: ISO 10993 is an international standard for the evaluation of biocompatibility, which includes a series of test items, such as cytotoxicity, skin irritation, allergenicity, etc.For TPU materials, relevant biocompatibility tests are required to ensure that they meet the requirements of ISO 10993 to prove their safety and acceptability in medical equipment.
3. FDA regulations: The U.S. FDA is very strict in the approval and supervision of medical devices.For TPU as a material in medical devices, it is necessary to submit a detailed application and conduct relevant clinical evaluations and tests to prove that its safety and effectiveness meet the requirements of the FDA.
4. USP Level VI requirements: The VI edition of the USP (United States Pharmacopoeia) stipulates the requirements for plastic materials in drug contact, including requirements for extract evaluation, cytotoxicity, and biocompatibility.As a material for medical equipment, TPU needs to meet the requirements of USP Level VI to ensure its safety and stability in drug contact.