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ISO 13485 Certified Biocompatible LSR Injection Molding Service for Sterilization-Compatible Medical Components
| Herkunftsort | Xiamen, Fujian, China |
|---|---|
| Markenname | Creator |
| Zertifizierung | ISO 9001:2015 |
| Modellnummer | KD-MED-SIL-001 |
| Min Bestellmenge | 100 Stück |
| Preis | negotiable |
| Verpackung Informationen | Exportkarton mit PE-Beutel, palettiert für den Containerversand |
| Lieferzeit | 25–35 Arbeitstage für neue Formen, 7–15 Tage für die Produktion |
| Zahlungsbedingungen | T/T, L/C, PayPal, Western Union |
| Versorgungsmaterial-Fähigkeit | 100.000 Stück pro Monat |
Produktdetails
| Material | LSR in medizinischer Qualität | Zertifizierung | ISO 13485:2016 |
|---|---|---|---|
| Sterilisation | EtO, Gamma, Autoklav | ||
| Hervorheben | ISO 13485 Certified Injection Molding Service,Biocompatible LSR Molding,Sterilization-Compatible Medical Silicone Molding |
||
Produkt-Beschreibung
Medical Grade Silicone Injection Molding Service for Surgical Instrument Handles ISO 13485 Cleanroom
Xiamen Creator Technology Co., Ltd. provides ISO 13485 certified medical-grade silicone injection molding for surgical instrument handles, grips, and medical device components. Our liquid silicone rubber (LSR) molding process in an ISO Class 8 cleanroom ensures biocompatible, sterilizable components meeting the most stringent medical industry requirements.
Key Features & Advantages
- ISO 13485:2016 certified medical device component manufacturing
- Liquid Silicone Rubber (LSR) injection molding in ISO Class 8 cleanroom
- Biocompatible materials per ISO 10993 standards
- Sterilization-compatible: EtO, Gamma irradiation, Steam autoclave
- Overmolding capability for soft-touch surgical instrument grips
- Full traceability with device history records and material certifications
Technical Specifications
| Certification | ISO 13485:2016, ISO 9001:2015 |
| Material | Medical-grade LSR, Solid Silicone, TPE |
| Cleanroom Class | ISO Class 8 (100,000) |
| Mold Material | S136 Stainless Steel, NAK80 |
| Mold Precision | ±0.01mm |
| Sterilization | EtO, Gamma, Autoclave Compatible |
| Durometer Range | 20 - 80 Shore A |
| Lead Time | 30-40 working days |
Manufacturing Excellence
Our dedicated medical molding facility features an ISO Class 8 cleanroom with HEPA filtration and positive pressure control. We utilize advanced LSR injection molding machines with precise temperature and pressure control for consistent silicone part quality. Every production lot undergoes rigorous inspection and is accompanied by complete device history records including material certifications, process parameters, and final QC reports.
Frequently Asked Questions
Q: Are your silicone materials medical grade?
A: Yes. We use medical-grade LSR and solid silicone materials that are biocompatible per ISO 10993 and suitable for surgical instrument applications.
Q: Can you produce overmolded surgical grips?
A: Yes. We offer LSR overmolding onto plastic or metal substrates for soft-touch surgical instrument handles with excellent chemical resistance.
Q: What sterilization methods are compatible?
A: Our silicone components are compatible with EtO gas, Gamma irradiation, and steam autoclave sterilization methods.
Q: Do you provide biocompatibility test reports?
A: We can provide material biocompatibility documentation from our raw material suppliers and coordinate additional testing through certified labs when needed.
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