Manufacturing of medical-grade silicone components with formulations tested under ISO 10993 and USP Class VI. Traceable production in a certified ISO 8 Cleanroom environment compliant with ISO 13485.
The medical sector demands materials with verified biocompatibility, repeated sterilization compatibility, and full process traceability. At ProSilicones64, we develop platinum-grade silicone compounds manufactured under an ISO 13485 system and tested according to ISO 10993-1/-5/-10, USP Class VI, and European Pharmacopoeia. All components are produced in an ISO 8 cleanroom with strict dimensional control, guaranteeing purity, stability, and REACH / RoHS compliance.
Components are manufactured under certified systems and tested formulations compliant with the main international frameworks that ensure quality, biocompatibility, and traceability.
| Normativa | Ámbito de aplicación |
|---|---|
| ISO 13485 | Quality management for medical devices (process certification) |
| ISO 10993 - 1 / - 5 / - 10 / - 11 | Biocompatibility and cytotoxicity testing (formulation verification) |
| USP Clase VI | Biological compatibility testing for medical elastomers (formulation testing) |
| Farmacopea Europea | Compliance for medical raw materials and additives (European Pharmacopoeia) |
| ISO 14971 | Risk management for medical devices |
| ISO 8 Cleanroom | Certified environment compliant with ISO 14644 for critical production |
| REACH / RoHS | European chemical compatibility and absence of restricted substances |
Medical-grade silicones are used in diagnostic, respiratory, treatment, and life support devices where safety and stability are essential:
