Safe elastomers for the healthcare industry
Increasingly portable and connected, medical devices represent a particularly demanding sector in terms of approvals for elastomers. ITC elastomer formulas are free of heavy metals, latex, halogens and phthalates and have been tested according to USP Class VI (chapter 88), ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous irritation), ISO 10993- 11 (acute systemic toxicity) and ISO 10993-4 (hemolysis). The quality control of the raw materials used also covers the full traceability of batches with our suppliers and also meets REACH and RoHS requirements.
Today, mainly electronic medical devices and equipment require not only chemically inert biocompatible elastomer solutions to guarantee the tightness of the systems but also controlled production processes. Our medical LSR press under ISO7 laminar flow allows us to transform a wide range of USP class VI silicones.
| ORGANISM | APPROVAL | DESCRIPTION |
|---|---|---|
| USP | USP class VI | In vivo biological reactivity test in animals |
| ISO | ISO 10993-5 ISO 10993-10 ISO 10993-11 ISO 10993-4 |
Cytotoxicity Intracutaneous irritation Acute systemic toxicity Hemolysis |
Applications
ITC elastomers are suitable for the production of components for medical use used in the manufacture of equipment for operating theaters, medical imaging, childcare or personal services.
