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YIXUN mold
8480419090
Reduces per-unit cost by 30-40% (vs. single-cavity molds).
Maintains ±0.02mm tolerance across all cavities (via high-precision CNC machining of mold cores/cavities).
Optimized for small-to-medium surgical parts (e.g., 50-200mm size range):
First shot: Injects medical PP (rigid substrate) into cavities.
Second shot: Overmolds biocompatible TPE (Shore 30-80A) onto PP—ensures ≥7MPa bond strength (meets surgical device durability requirements).
Mold features dual-shot/insert overmold systems (cleanroom-class):
Material compliance: PP/TPE meet ISO 10993-1/-5/-10 (non-toxic, hypoallergenic).
Mold cores/cavities: Stainless steel (S136H) or H13 tool steel (corrosion-resistant, autoclave-compatible for mold cleaning).
Surface finish: Ra 0.025μm (mirror polish) to prevent microbial buildup and ensure smooth part release.
Mold production in ISO 8 cleanrooms (critical for avoiding contamination of surgical parts).
Mold components (e.g., hot runners, cooling systems) are sealed to meet medical device hygiene standards.
Cavity layout (balanced flow for uniform overmolding).
Gate location (minimizes TPE flash on surgical part surfaces).
Cooling system (prevents PP/TPE warpage in multi-cavity runs).
Our engineering team reviews your part 3D model (STEP/IGS) to optimize:
High-precision machining (5-axis CNC, EDM) for mold cores/cavities.
Assembly & testing: Dry-run with PP/TPE to verify cavity fill, bond strength, and tolerance consistency.
Biocompatibility testing (ISO 10993).
Functional validation (grip strength, sterilization resistance).
Provide 50-100 prototype parts for:
Assist with injection machine parameter tuning (for 2-shot overmolding).
Offer mold maintenance (cleaning, component replacement) to ensure 1M+ part lifespans.
| Parameter | Details |
|---|---|
| Cavity Count | 2, 4, 8, 16 (customizable based on part size) |
| Mold Tolerance | ±0.01mm (core/cavity); ±0.02mm (part critical dimensions) |
| Overmold Bond Strength | ≥7MPa (tested per ASTM D4541) |
| Material Compatibility | Medical PP (ISO 10993) + Medical TPE (ISO 10993, Shore 30-80A) |
| Regulatory Compliance | Mold manufacturing per ISO 13485; parts compatible with FDA 510(k)/CE MDR |
| Lead Time | 4-6 weeks (mold fabrication); 1 week (sample validation) |
Medical Expertise: 10+ years of experience in surgical device mold design (no rework for regulatory non-compliance).
Cost Efficiency: Multi-cavity molds reduce production time by 50% for high-volume orders (100k+ parts/year).
Traceability: Full documentation (mold material certificates, machining logs) for medical device QMS.

Reduces per-unit cost by 30-40% (vs. single-cavity molds).
Maintains ±0.02mm tolerance across all cavities (via high-precision CNC machining of mold cores/cavities).
Optimized for small-to-medium surgical parts (e.g., 50-200mm size range):
First shot: Injects medical PP (rigid substrate) into cavities.
Second shot: Overmolds biocompatible TPE (Shore 30-80A) onto PP—ensures ≥7MPa bond strength (meets surgical device durability requirements).
Mold features dual-shot/insert overmold systems (cleanroom-class):
Material compliance: PP/TPE meet ISO 10993-1/-5/-10 (non-toxic, hypoallergenic).
Mold cores/cavities: Stainless steel (S136H) or H13 tool steel (corrosion-resistant, autoclave-compatible for mold cleaning).
Surface finish: Ra 0.025μm (mirror polish) to prevent microbial buildup and ensure smooth part release.
Mold production in ISO 8 cleanrooms (critical for avoiding contamination of surgical parts).
Mold components (e.g., hot runners, cooling systems) are sealed to meet medical device hygiene standards.
Cavity layout (balanced flow for uniform overmolding).
Gate location (minimizes TPE flash on surgical part surfaces).
Cooling system (prevents PP/TPE warpage in multi-cavity runs).
Our engineering team reviews your part 3D model (STEP/IGS) to optimize:
High-precision machining (5-axis CNC, EDM) for mold cores/cavities.
Assembly & testing: Dry-run with PP/TPE to verify cavity fill, bond strength, and tolerance consistency.
Biocompatibility testing (ISO 10993).
Functional validation (grip strength, sterilization resistance).
Provide 50-100 prototype parts for:
Assist with injection machine parameter tuning (for 2-shot overmolding).
Offer mold maintenance (cleaning, component replacement) to ensure 1M+ part lifespans.
| Parameter | Details |
|---|---|
| Cavity Count | 2, 4, 8, 16 (customizable based on part size) |
| Mold Tolerance | ±0.01mm (core/cavity); ±0.02mm (part critical dimensions) |
| Overmold Bond Strength | ≥7MPa (tested per ASTM D4541) |
| Material Compatibility | Medical PP (ISO 10993) + Medical TPE (ISO 10993, Shore 30-80A) |
| Regulatory Compliance | Mold manufacturing per ISO 13485; parts compatible with FDA 510(k)/CE MDR |
| Lead Time | 4-6 weeks (mold fabrication); 1 week (sample validation) |
Medical Expertise: 10+ years of experience in surgical device mold design (no rework for regulatory non-compliance).
Cost Efficiency: Multi-cavity molds reduce production time by 50% for high-volume orders (100k+ parts/year).
Traceability: Full documentation (mold material certificates, machining logs) for medical device QMS.
