| Quantity: | |
|---|---|
YIXUN mold
8480419090
Diagnostic device parts: Microfluidic chips (for in vitro diagnostics), reagent cartridge components, test tube connectors.
Surgical & treatment accessories: Infusion set connectors, dental implant abutment sleeves, catheter guide components.
Medical equipment components: Ventilator valve parts, monitor housing structural components, insulin pump precision fittings.
Disposable medical supplies: Sterile syringe plungers, blood collection tube seals, wound dressing fixators.
Mold material: Use medical-grade stainless steel (e.g., S136H) with corrosion resistance, processed via 5-axis CNC (machining accuracy ≤±0.005mm) to ensure fitting precision of tiny structures (e.g., microfluidic channels).
Mold features: Integrate hot runner systems (to reduce material waste) and temperature-controlled cooling channels (to avoid component warpage).
Exclusive use of FDA/ISO-approved materials: Medical-grade PP, ABS, PEEK, TPE, etc., which meet ISO 10993 (biocompatibility: no cytotoxicity, sensitization, or irritation) and USP Class VI standards.
Material preparation: Dry in a Class 8 cleanroom (to avoid contamination) and avoid any additives that may leach harmful substances.
Precision control: Melt temperature (190–240°C, material-dependent), injection pressure (60–100MPa), and holding pressure (20–40MPa) are fine-tuned to ensure dimensional accuracy (tolerance ≤±0.01mm for critical parts).
Cycle stability: Automated injection lines with real-time monitoring (temperature, pressure) to maintain consistency across 100k+ production cycles.
Manufactured in ISO 14644-1 Class 7 (or higher) cleanrooms to prevent microbial/particulate contamination (critical for sterile components like syringe parts).
ISO 13485: Medical device quality management system (covers the entire process from mold design to production).
ISO 10993: Biocompatibility evaluation (tests for cytotoxicity, skin sensitization, and mucosal irritation).
FDA 21CFR §177: Food-contact & medical-contact plastic material safety.
CE MDR 2017/745: EU regulatory requirements for medical device components.
Sub-micron precision: Ensures seamless fitting of medical devices (e.g., microfluidic chips for accurate diagnostic results).
Sterility assurance: Compatible with gamma irradiation/EO sterilization (SAL ≥10⁻⁶) for disposable medical supplies.
Batch consistency: Reduces device failure risks caused by component dimensional variations.
Diagnostic device parts: Microfluidic chips (for in vitro diagnostics), reagent cartridge components, test tube connectors.
Surgical & treatment accessories: Infusion set connectors, dental implant abutment sleeves, catheter guide components.
Medical equipment components: Ventilator valve parts, monitor housing structural components, insulin pump precision fittings.
Disposable medical supplies: Sterile syringe plungers, blood collection tube seals, wound dressing fixators.
Mold material: Use medical-grade stainless steel (e.g., S136H) with corrosion resistance, processed via 5-axis CNC (machining accuracy ≤±0.005mm) to ensure fitting precision of tiny structures (e.g., microfluidic channels).
Mold features: Integrate hot runner systems (to reduce material waste) and temperature-controlled cooling channels (to avoid component warpage).
Exclusive use of FDA/ISO-approved materials: Medical-grade PP, ABS, PEEK, TPE, etc., which meet ISO 10993 (biocompatibility: no cytotoxicity, sensitization, or irritation) and USP Class VI standards.
Material preparation: Dry in a Class 8 cleanroom (to avoid contamination) and avoid any additives that may leach harmful substances.
Precision control: Melt temperature (190–240°C, material-dependent), injection pressure (60–100MPa), and holding pressure (20–40MPa) are fine-tuned to ensure dimensional accuracy (tolerance ≤±0.01mm for critical parts).
Cycle stability: Automated injection lines with real-time monitoring (temperature, pressure) to maintain consistency across 100k+ production cycles.
Manufactured in ISO 14644-1 Class 7 (or higher) cleanrooms to prevent microbial/particulate contamination (critical for sterile components like syringe parts).
ISO 13485: Medical device quality management system (covers the entire process from mold design to production).
ISO 10993: Biocompatibility evaluation (tests for cytotoxicity, skin sensitization, and mucosal irritation).
FDA 21CFR §177: Food-contact & medical-contact plastic material safety.
CE MDR 2017/745: EU regulatory requirements for medical device components.
Sub-micron precision: Ensures seamless fitting of medical devices (e.g., microfluidic chips for accurate diagnostic results).
Sterility assurance: Compatible with gamma irradiation/EO sterilization (SAL ≥10⁻⁶) for disposable medical supplies.
Batch consistency: Reduces device failure risks caused by component dimensional variations.
