Ваш авторизованный поставщик термопластичных эластомеров - ТПЭ для инжекции и экструзии

Нет - мы уполномочены дистрибьютор термопластичных эластомеровМы предлагаем прямые поставки и полную техническую поддержку. 

Мы помогаем клиентам подобрать нужный уровень твердости в соответствии с их назначением - от ультрамягких изделий для контакта с кожей до структурных захватов или гибких кабелей.

Thermoplastic Elastomers (TPEs) are widely used in medical applications due to their excellent flexibility, softness, biocompatibility potential, and ease of processing. Key factors for medical TPEs include:

• Biocompatibility: The material should not cause adverse reactions when in contact with the body. Many medical-grade TPEs are specifically formulated and tested for this.

• Sterilization Resistance: TPEs used in medical devices often need to withstand common sterilization methods like autoclaving (steam), ethylene oxide (EtO), or gamma radiation without significant degradation.

• Purity and Extractables/Leachables: Medical TPEs should have low levels of extractable or leachable substances that could contaminate drugs or harm patients.

• Specific Properties: Depending on the application (e.g., tubing, seals, grips, tourniquets), properties like kink resistance, clarity, tensile strength, and resealability are crucial.

Important Compliance Standards:
When sourcing TPEs for medical devices, it’s vital to consider compliance with recognized standards. Manufacturers often test their medical-grade TPEs against standards such as:

• ISO 10993: A series of standards for evaluating the biocompatibility of medical devices.

• USP Class VI (United States Pharmacopeia): A common standard for plastics used in medical applications, involving specific biological reactivity tests.

• FDA Regulations: For TPEs that may come into contact with food or drugs, relevant FDA (U.S. Food and Drug Administration) regulations (e.g., 21 CFR) may apply.

• European Pharmacopoeia (EP) or specific EU regulations may also be relevant depending on the target market.

Leading thermoplastic elastomer supplier often provide detailed information on the compliance of their medical-grade TPEs.

For example, you can find insights into how specialized TPEs (like Hydrogenated Styrenic Block Copolymers – HSBCs) meet these rigorous requirements on resources provided by manufacturers such as [Kuraray, detailing their medical-grade TPEs and relevant compliances].