Su proveedor autorizado de elastómeros termoplásticos - TPE para inyección y extrusión

No - somos los autorizados distribuidor de elastómeros termoplásticos, que ofrece suministro directo con asistencia técnica completa. 

Ayudamos a los clientes a encontrar el nivel de dureza adecuado para cada caso de uso, desde productos ultrasuaves para el contacto con la piel hasta empuñaduras estructurales o cables flexibles.

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].