NovabelvarispxPhysical Requirements for Contact Materials
Components for ear hygiene and ear canal coupling often remain for several hours in the warm, humid environment of the outer ear. This environment requires materials that do not release cytotoxic plasticizers and remain chemically inert against acidic sebum. Novabelvarispx specifies medical silicone for earpieces and 304 stainless steel for mechanically stressed irrigation instruments.
Specifications for Medical Silicone
The silicone used is processed by injection molding. Material hardness ranges from forty to sixty Shore A. This range ensures that the earpiece conforms to irregularities in the ear canal without causing pressure necrosis on the thin skin covering the cartilage. The material is resistant to isopropanol and does not tear under tensile stress from tube connectors.
- Quality inspection: Inspection for flash-free mold parting lines using optical measuring microscopes.
- Traceability: Batch-specific documentation of raw silicone compounds according to ISO testing standards.
- Aging test: Storage in artificial skin sebum for fourteen days to assess swelling.
Corrosion Resistance of 304 Stainless Steel
Irrigation cannulas made of 304 stainless steel have a passive chromium oxide layer. This layer prevents rust formation upon contact with disinfectant solutions and permits thermal processing at up to one hundred forty degrees Celsius. ABS plastic on housing components also ensures the necessary impact resistance in the event of accidental drops onto solid surfaces.