| Quantity: | |
|---|---|
YIXUN mold
8480419090
Optimized for biocompatible materials: Rigid substrates (PC, ABS, PEEK) paired with soft overmold materials (medical TPE, silicone).
Mold surfaces are treated to prevent material contamination, ensuring compliance with sterile medical device requirements.
±0.005mm dimensional tolerance to meet tight fit requirements for medical device assemblies.
Advanced overmold design (multi-shot or insert molding capability) ensures seamless bonding between rigid and soft components.
Constructed from S136 stainless steel (corrosion-resistant, easy to sterilize) for 500,000+ production cycles.
Smooth, burr-free cavity surfaces eliminate debris risks — critical for sterile medical environments.
Ergonomic Design: Soft overmold layers enhance grip for surgical tools or patient-handled devices.
Biocompatibility: Materials meet USP Class VI standards (safe for direct/indirect patient contact).
Functional Integration: Bonds rigid structural components (e.g., instrument handles) with soft seals or cushioning layers.
Overmold types: Single-shot, multi-shot, or insert overmolding (for complex device assemblies).
Cavity count: 1–4 cavities (optimized for low-to-medium volume medical production).
Surface finish: Smooth, micro-textured, or matte (per device sterilization/handling requirements).
Regulatory Alignment: Mold design and production adhere to ISO 13485 (medical device quality management) and FDA guidelines.
Traceability: Full documentation of mold materials, machining processes, and quality checks (required for medical device regulatory submissions).
Optimized for biocompatible materials: Rigid substrates (PC, ABS, PEEK) paired with soft overmold materials (medical TPE, silicone).
Mold surfaces are treated to prevent material contamination, ensuring compliance with sterile medical device requirements.
±0.005mm dimensional tolerance to meet tight fit requirements for medical device assemblies.
Advanced overmold design (multi-shot or insert molding capability) ensures seamless bonding between rigid and soft components.
Constructed from S136 stainless steel (corrosion-resistant, easy to sterilize) for 500,000+ production cycles.
Smooth, burr-free cavity surfaces eliminate debris risks — critical for sterile medical environments.
Ergonomic Design: Soft overmold layers enhance grip for surgical tools or patient-handled devices.
Biocompatibility: Materials meet USP Class VI standards (safe for direct/indirect patient contact).
Functional Integration: Bonds rigid structural components (e.g., instrument handles) with soft seals or cushioning layers.
Overmold types: Single-shot, multi-shot, or insert overmolding (for complex device assemblies).
Cavity count: 1–4 cavities (optimized for low-to-medium volume medical production).
Surface finish: Smooth, micro-textured, or matte (per device sterilization/handling requirements).
Regulatory Alignment: Mold design and production adhere to ISO 13485 (medical device quality management) and FDA guidelines.
Traceability: Full documentation of mold materials, machining processes, and quality checks (required for medical device regulatory submissions).
