Industrial Silicone Manufacturing in ISO 13485 and ISO 9001 Environments
Discover how silicone components are manufactured under ISO 13485 and ISO 9001 quality management systems.
Development and manufacturing of FVMQ, PVMQ, and VMQ silicone components with high thermal and radiological resistance. Production under ISO 9001 / EN 9100 system and ISO 8 cleanroom. Formulations tested according to ISO 10993-11, ISO 37, and ISO 3302 for critical safety environments.
The nuclear sector demands materials with thermal, chemical, and radiological stability capable of maintaining their performance in environments subjected to ionizing radiation, partial vacuum, differential pressure, and prolonged exposure to oxidizing agents. At ProSilicones64, we manufacture FVMQ, PVMQ, and VMQ silicone components under a certified ISO 8 environment and ISO 9001 / EN 9100 quality management, ensuring complete batch traceability and dimensional control according to ISO 3302 E1/L2. Formulations are tested compliant with ISO 10993-11 (systemic toxicity), NF ISO 37 (tensile strength), and ISO 34-1 (tear resistance), ensuring chemical compatibility, stability, and low outgassing even after prolonged gamma exposure.
Technical silicone components for nuclear applications are manufactured in certified environments with formulations tested according to the main international standards that ensure radiological, chemical, and thermal stability.
| Normativa | Ámbito de aplicación |
|---|---|
| ISO 9001 / EN 9100 | Quality management and process traceability (system certification) |
| ISO 10993-11 | Systemic toxicity testing and biological compatibility (formulation verification) |
| NF ISO 37 / ISO 34-1 | Tensile strength and tear resistance testing (mechanical performance validation) |
| ISO 3302 E1/L2 | Dimensional control and tolerances in elastomers (precision manufacturing) |
| ISO 8 Cleanroom | Production in certified environment ISO 14644-1 (particles ≤100,000/m³) |
| REACH / RoHS | European chemical compatibility and absence of restricted substances |
Technical knowledge and application cases in this sector.
Discover how silicone components are manufactured under ISO 13485 and ISO 9001 quality management systems.