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Mold Maker Injection Mold for Medical Hard Plastic Clear PC Material Overmold

Our Medical-Grade Overmolded Components combine rigid substrates (metal/engineering plastics) with biocompatible elastomers (LSR/TPE) via precision overmolding—creating seamless, high-performance parts for medical devices. Designed to meet strict regulatory standards (ISO 13485, ISO 10993), these components balance durability, ergonomics, and patient safety for clinical and home-care applications.
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  • YIXUN mold

  • 8480419090

Medical-Grade Overmolded Components

(For Devices, Instruments & Patient-Care Products)

Product Introduction

Our Medical-Grade Overmolded Components combine rigid substrates (metal/engineering plastics) with biocompatible elastomers (LSR/TPE) via precision overmolding—creating seamless, high-performance parts for medical devices. Designed to meet strict regulatory standards (ISO 13485, ISO 10993), these components balance durability, ergonomics, and patient safety for clinical and home-care applications.

Key Applications

  1. Surgical Instruments
    • Overmolded handles (e.g., electric scalpel grips): Soft-touch TPE/LSR layers improve grip (even with gloves) and reduce hand fatigue during long procedures.

    • Features: Antimicrobial surfaces (≥99% bacteria inhibition) and X-ray visibility (for retained instrument detection).

  2. Fluid Management Devices
    • Dialysis machine connectors, IV set ports: LSR-overmolded metal/plastic joints ensure leak-proof sealing (up to 1.6MPa pressure) and compatibility with ETO/steam sterilization (134°C, 500+ cycles).

  3. Patient-Care Tools
    • Blood glucose monitor strips (overmolded sensors): Seamless encapsulation protects electronics from moisture while maintaining biocompatibility with skin/tissue.

    • Wheelchair grips & orthopedic device pads: Cushioned TPE layers enhance comfort and reduce pressure sores.

  4. Wearable Medical Devices
    • ECG patch electrodes, insulin pump casings: Water-resistant LSR overmolding ensures 7+ days of skin contact safety (hypoallergenic, ISO 10993-5 certified).

Core Advantages

Benefit Details
Biocompatibility Materials (LSR/TPE) meet ISO 10993-1/-5/-10 standards (no cytotoxicity/sensitization).
Sterilization Resistance Withstands autoclaving, gamma irradiation, and chemical disinfection (no material degradation).
Seamless Hygiene No assembly joints/crevices—reduces microbial buildup (critical for infection control).
Ergonomic Design Soft-touch surfaces improve clinician/patient comfort; non-slip grips enhance procedural safety.
Durability Bond strength ≥7MPa (between substrate & elastomer); resists abrasion/solvents (e.g., isopropyl alcohol).

Technical Specifications

  • Substrates: Stainless steel, PEEK, PC, PP (medical-grade, traceable raw materials).

  • Overmold Materials: Liquid Silicone Rubber (LSR 40-70 Shore A), Thermoplastic Elastomer (TPE 30-80 Shore A).

  • Tolerances: ±0.02mm (critical dimensions for device compatibility).

  • Regulatory Compliance: CE MDR, FDA 510(k), ISO 13485 (manufacturing process).

  • Customization: Color coding (for device identification), texture optimization (grip/comfort), and micro-overmolding (for miniaturized components).

Manufacturing Process

  1. Substrate Preparation: Plasma etching/chemical priming of metal/plastic substrates to enhance elastomer adhesion.

  2. 2-Shot/Insert Overmolding: Automated injection molding (class 8 cleanroom) to bond elastomer to substrate in a single cycle.

  3. Post-Processing: Deburring, visual inspection (100% AOI), and biocompatibility testing (batch-wise ISO 10993 validation).

medical components

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Yixun is the China first generation mold maker, specialize in mold and moulding, provide one-stop plastic manufacturing service, feature in building medical and healthcare device tooling.
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