Applications of TPU films have been designated by leading manufacturers in pharmaceuticals, healthcare products, hospital equipment, bio-medical devices, and personal protective equipment (PPE) for medical staff.

TPU is highly favored in many markets for its high performance, especially in the broad spectrum of applications in the healthcare sector, ranging from artificial heart components and blood plasma bags to isolation tents in hospitals. Its high strength, tear resistance, and biocompatibility continue to fuel innovation in products across the medical market. New applications emerge continually, particularly where medical device manufacturers actively drive market expansion for available application types (such as isolation membranes or wound dressings).

Polyurethane is reputable for its superiority in these demanding environments. In medical settings, materials often rub against one another or bend. Without TPU grades, these materials are more prone to fatigue or weaken. Enhancing material performance with TPU has become a significant avenue driving product design and innovation.

As the TPU industry develops, the technological barriers are no longer the decisive obstacles in the medical field. The number of TPU suppliers who can meet medical requirements and possess corresponding production capacities is gradually increasing. However, the major medical-grade TPU suppliers on the market are still relatively limited. The biggest challenge is certification. Currently, the main certification standards for medical-grade TPUs include:

1. Regulation (EU) 2017/745 - MDR: According to the EU’s medica device regulation (MDR), all medical devices sold in Europe need to comply with new clinical evaluation requirements, including requirements for material biocompatibility, chemical composition, traceability, and other aspects. TPU, as a material in medical devices, needs to undergo a series of tests and evaluations to ensure its compliance with MDR, which may require time and resources.

2. ISO 10993: ISO 10993 is an international standard regarding biocompatibility assessment, including a series of test items such as cytotoxicity, skin irritation, sensitization, and more. For TPU materials, relevant biocompatibility tests need to be conducted to ensure compliance with ISO 10993 requirements, proving their safety and applicability in medical devices.

3. FDA Regulations: The U.S. FDA has strict approval and regulation processes for medical devices. For TPU as a material in medical devices, comprehensive applications need to be submitted, along with relevant clinical evaluations and tests to demonstrate compliance with FDA requirements for safety and efficacy.

4. USP Class VI: The U.S. Pharmacopeia (USP) Class VI specifies requirements for plastic materials in contact with pharmaceuticals, including assessments on extractables, cytotoxicity, biocompatibility, and more. TPU, as a material in medical devices, needs to meet the requirements of USP Class VI classification to ensure its safety and stability when in contact with pharmaceuticals.

 

If you are interested in the challenges of TPU certification in the medical industry and wish to further explore how to realize your ideas, feel free to contact us. Our team has extensive experience in market research and consulting, alongside innovative solutions. We look forward to assisting you in achieving your goals.

Contactor: Audrey Liu

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