WICSilicone Certificates
WICSilicone upholds international quality standards through verified certifications. Our ISO and industry-compliant certificates demonstrate our commitment to delivering reliable, high-performance silicone products for automotive, medical, and industrial applications.
ISO/TS 16949
ISO 9002
ISO 3808
ISO 9001
ISIRI 4267-2
ISO 17025
10993-5
10993-10
10993-4
Pharma
ASTM F756
Certifications & Compliance
Reinforcing our commitment to global standards, WICSilicone materials and processes meet European (EN), American (ASTM/ISO), and internationally recognized benchmarks. Manufactured from biocompatible, medical-grade silicone compounds, our products—from automotive parts and medical LSR molded solutions to electrical insulation, construction, and food-contact applications—ensure safety, regulatory compliance, and consistent performance.
Certification Table - 1
| Certification | Description |
|---|---|
| ISO 9001 (CSQ) | Quality management standard for ignition cables and wiring. |
| ISO/TS 16949 (CSQ Auto) | Automotive-specific quality system for ignition systems. |
| ISO 9001 (IQNET) | Internationally recognized quality system certification. |
| DIN EN ISO 9002 (TÜV) | TÜV-certified quality system for ignition cable production. |
Our manufacturing follows ISO 3808-defined performance standards to guarantee durable and high-temperature-resistant automotive and electronic components.
Certification Table -2
| Certification | Description |
|---|---|
| ISIRI 4267-2 | Certified for manufacturing automotive ignition cables in Iran with global standard compatibility. |
| ISIRI-ISO/IEC 17025 | Accredited lab for test and calibration services. |
| ISO 10993-4 | Tests for blood-material interactions, confirming biocompatibility. |
| ISO 10993-5 | In vitro cytotoxicity testing for medical devices. |
| ISO 10993-10 | Evaluation for skin irritation and sensitization. |
WICSilicone’s materials meet both European Pharmacopoeia and ISO 10993 biocompatibility requirements.
Our medical-grade silicones are tested for cytotoxicity, sensitization, and hemolysis — ensuring safety for healthcare and life science applications.
Certification Table -3
| Certification | Description |
|---|---|
| European Pharmacopoeia | Certified silicone elastomers for closures, tubing, and medical devices. |
| ISO 3808 | Performance standard for automotive ignition cable systems. |
| ASTM F756 | Assessment of hemolytic properties of materials. |
Official Certifications & Accreditations
Access downloadable certificates – PDF file below – to verify our dedication to quality, reliability, and environmental responsibility.
- ISO 9001 – Internationally recognized quality control and management system
- DIN EN ISO 9002 – TÜV-certified quality system for ignition cable production
- IATF 16949– Automotive quality certification for automotive-grade silicone components.
- ISIRI 4267-2 – Certified for manufacturing automotive ignition cables (Iran)
- ISIRI–ISO/IEC 17025 – Accredited laboratory for testing and calibration
- ISO 10993-4 – Blood–material interaction testing
- ISO 10993-10 – Skin irritation and sensitization testing
- ISO 10993-5 – In vitro cytotoxicity
- European Pharmacopoeia – Certified silicone elastomers for closures and pharmaceutical tubing
Industry Standards We Follow (Compliance)
Automotive & Industrial Standards
- ISO 3808 – Performance standard for automotive ignition cable systems .(Quality Management)
- LV112 / LV214 (Automotive cables) – Electrical, thermal, and fire qualification for automotive wiring.
- SAE J2031 — Silicone ignition cable construction
- ISO 6722 — Automotive wire requirements
- ISO 7622 — Thermal/mechanical cable insulation testing
- UL 94 — Flammability rating for silicone components
- RoHS — Hazardous substance restriction (Chemical & Material Safety)
- REACH — EU chemical safety compliance (Chemical & Material Safety)
- Halogen-Free — Chlorine/bromine-free formulations– essential for fire-safe cables. (Chemical & Material Safety)
- PAH / VOC / Heavy metals — Material safety for medical and automotive use (Chemical & Material Safety)
Medical & Biocompatibility Standards
- ISO 10993-1 — Biological evaluation framework
- ISO 10993-11 — Systemic toxicity
- ISO 10993-18 — Chemical characterization
- USP Class VI — Biocompatibility for medical polymers
- FDA 21 CFR 177.2600 — Silicone for food and skin contact
- ISO 13485 (Process Alignment) — Medical device quality principles
- ISO 14644 — Cleanroom-compatible production through partner facilities
Material & Compound Testing Standards
- ASTM D412 — Tensile properties
- ASTM D2240 — Shore A hardness
- ASTM D573 — Heat aging
- ASTM D2000 — Rubber material classification
- ASTM D624 – Tear resistance
Certification Roadmap
- ISO 13485 — Medical device manufacturing
- ISO 14001 — Environmental management– Environmental compliance for international manufacturing.
- ISO 45001 — Occupational health & safety– Safety management for chemical/industrial environments.