Medical Silicone
Non-implantable silicone components with imported LSR and full material traceability
Product Overview
SIKING manufactures custom silicone components suitable for non-implantable medical device applications where material traceability and process control are primary requirements. Production uses exclusively imported Liquid Silicone Rubber (LSR) from Dow, Wacker ELASTOSIL, and Shin-Etsu — not domestic Chinese material.
Components are produced in a Class 100K cleanroom via LSR injection molding. Material traceability from raw material batch through finished part is maintained and documented.
- LSR suppliers: Dow, Wacker ELASTOSIL, Shin-Etsu
- Material suppliers provide biocompatibility documentation for their raw LSR materials
- Cleanroom: Class 100K production environment
- Tolerance: ±0.02mm (standard for LSR injection)
- ISO 13485 certification: SIKING is pursuing ISO 13485 certification — not currently held
What SIKING Can and Cannot Claim
Procurement engineers evaluating medical component suppliers should verify certifications directly. SIKING's current compliance position is as follows:
✓ What SIKING holds
- ISO 9001:2015 — Quality management system
- ISO 14001:2015 — Environmental management
- Imported LSR with supplier biocompatibility documentation
- Class 100K cleanroom production capability
⚠ Certifications in progress — not held
- ISO 13485 — SIKING is pursuing this certification
- FDA 21 CFR 820 — not applicable or claimed
- ISO 10993 biocompatibility testing — not held at part level
- USP Class VI — not claimed
Imported LSR Material Stack
All medical silicone components use imported LSR. SIKING does not substitute domestic Chinese material for medical applications.
Dow SILASTIC
Dow's SILASTIC LSR range is used for applications where the material supplier's biocompatibility documentation is required as part of the device file. Dow provides standard material data for SILASTIC grades.
Wacker ELASTOSIL
Wacker ELASTOSIL LSR grades are used for micro-molding applications requiring tight dimensional tolerances. ELASTOSIL grades are available in medical-purpose formulations from Wacker's standard catalogue.
Shin-Etsu
Shin-Etsu LSR is available as an alternative supply source for projects where dual-sourcing the raw material is part of the supply chain risk management plan.
Traceability: For each production batch, SIKING maintains records of the raw material lot number, material supplier CoA, cleanroom batch records, and dimensional inspection reports. These records are available on request as part of the shipment documentation package.
Process Specifications
| Parameter | Specification | Notes |
|---|---|---|
| Production environment | Class 100K cleanroom | Particle count controlled |
| Dimensional tolerance | ±0.02mm (standard) | Tighter tolerances: DFM review required |
| Hardness (Shore A) | 15–80 | Softer grades (15–30) for comfort applications |
| Defect rate | ≤1,000 DPPM | Reported from active production |
| MOQ | 1,000 units (tooled parts) | FAI and sampling available below MOQ |
Suitable Applications
Non-implantable device components where material traceability and process control are the primary qualification requirements.
Hearing Aid Components
Micro-molded LSR cushions and dome seals. Tolerances to ±0.02mm in sub-10mm geometry. Primary proof point in SIKING's medical production history — see Medical industry page →
Breathing Mask Parts
Soft facial seal components, valve seals, and interface cushions for respiratory masks. Softness and skin-contact comfort are primary material selection criteria.
Wearable Sensor Housings
Over-molded or standalone silicone housings for skin-worn sensors. Soft-touch, skin-compatible materials in custom colors and geometries.
Diagnostic Device Seals
Sealing components for handheld and benchtop diagnostic instruments. Material documentation and batch traceability available as standard for these applications.
Manufacturing Process
Medical silicone components are produced by LSR injection molding on SIKING's two dedicated LSR injection units, located within the Class 100K cleanroom. LSR injection provides tighter dimensional control than compression molding and is preferred for small, precise geometries.
The closed-mold injection process minimises contamination exposure during production. Post-molding handling occurs within the cleanroom environment through packaging.
- Two dedicated LSR injection units
- Class 100K cleanroom — particle-controlled environment
- Closed-mold process — minimal post-molding contamination exposure
- Batch records and material CoA documentation included
Evaluating SIKING for a Medical Application?
Share your component drawing and application description. We'll confirm suitability, material selection, and documentation available — before you commit to tooling.