| Quantity: | |
|---|---|
YIXUN mold
8480419090
Compliance: Fully meets ISO 13485 (medical device quality management) and FDA 21 CFR Part 820; traceable from material to final product.
Biocompatibility: Uses USP Class VI/ISO 10993-compliant materials (PP, PE, PC, ABS, PEEK, medical-grade TPE); no leachables/extractables.
Precision & Durability: Dimensional tolerance ±0.005–0.02 mm; surface finish Ra≤0.1 μm; resistant to autoclave/EO/γ sterilization.
Customization: Tailored for surgical instruments, implants, and minimally invasive device components with strict process validation.
| Parameter | Details |
|---|---|
| Material | Medical-grade PP, PE, PC, ABS, PEEK, TPE (USP Class VI/ISO 10993) |
| Dimensional Tolerance | ±0.005 mm (critical features); ±0.01–0.02 mm (general features) |
| Surface Finish | Mirror polish (Ra≤0.1 μm); electrolytic polishing for implantable parts |
| Sterilization Compatibility | Autoclave (121°C/2 bar), EO gas, γ radiation (25–40 kGy) |
| Production Process | High-precision injection molding; cleanroom (Class 8/100,000) manufacturing |
| Quality Standard | ISO 13485, FDA 21 CFR Part 820; batch-to-batch traceability |
Risk Management: FMEA (Failure Mode and Effects Analysis) applied to design and production to mitigate clinical risks.
Traceability: Full material lot tracking, process parameter logging, and batch records for recall readiness.
Process Validation: Validated injection molding, cleaning, and sterilization processes to ensure consistent quality.
Regulatory Compliance: Aligns with EU MDR, US FDA, and other global medical device regulations.
Surgical Instruments: Lightweight, sterilizable handles for forceps, scissors, and retractors (e.g., PEEK/PC blends for strength and chemical resistance).
Minimally Invasive Devices: Catheter hubs, trocar components, and endoscope housings (biocompatible TPE/PP for flexibility and leak-proof seals).
Implantable Accessories: Guidewire components, suturing device parts (PEEK for biostability and radiolucency).
Disposable Surgical Kits: Syringe plungers, drug delivery components, and wound closure device parts (medical-grade PP/PE for single-use sterility).
Material Selection: Use certified medical-grade plastics with USP Class VI/ISO 10993 test reports (biocompatibility, cytotoxicity, hemocompatibility).
Cleanroom Production: Manufactured in ISO 8 (Class 100,000) cleanrooms to avoid particulate contamination.
Precision Molding: High-tolerance tooling (S136 steel) with CMM inspection for critical dimensions (±0.005 mm).
Sterilization Validation: Validated cycles for autoclave (121°C/15 min), EO gas, or γ radiation (25–40 kGy) to ensure sterility assurance level (SAL) of 10⁻⁶.
Traceability System: Unique batch codes link each part to raw materials, production parameters, and inspection records.
Audit & Certification: Annual ISO 13485 surveillance audits; documentation of design controls, risk management, and corrective/preventive actions (CAPA).
Material: Medical-grade PEEK (biocompatible, high strength, heat-resistant).
Tolerance: ±0.01 mm on grip dimensions for secure instrument attachment.
Surface Finish: Ra≤0.1 μm (electrolytic polish) to prevent bacterial adhesion.
Sterilization: Autoclave-compatible (134°C/3 min) for repeated use.
Compliance: ISO 13485, FDA 21 CFR Part 820, USP Class VI.
Request a valid ISO 13485 certificate from the manufacturer (check accreditation body and expiration date).
Review material test reports (USP Class VI/ISO 10993) and sterilization validation records.
Confirm the manufacturer has a traceability system and documented risk management processes (per ISO 14971).
Compliance: Fully meets ISO 13485 (medical device quality management) and FDA 21 CFR Part 820; traceable from material to final product.
Biocompatibility: Uses USP Class VI/ISO 10993-compliant materials (PP, PE, PC, ABS, PEEK, medical-grade TPE); no leachables/extractables.
Precision & Durability: Dimensional tolerance ±0.005–0.02 mm; surface finish Ra≤0.1 μm; resistant to autoclave/EO/γ sterilization.
Customization: Tailored for surgical instruments, implants, and minimally invasive device components with strict process validation.
| Parameter | Details |
|---|---|
| Material | Medical-grade PP, PE, PC, ABS, PEEK, TPE (USP Class VI/ISO 10993) |
| Dimensional Tolerance | ±0.005 mm (critical features); ±0.01–0.02 mm (general features) |
| Surface Finish | Mirror polish (Ra≤0.1 μm); electrolytic polishing for implantable parts |
| Sterilization Compatibility | Autoclave (121°C/2 bar), EO gas, γ radiation (25–40 kGy) |
| Production Process | High-precision injection molding; cleanroom (Class 8/100,000) manufacturing |
| Quality Standard | ISO 13485, FDA 21 CFR Part 820; batch-to-batch traceability |
Risk Management: FMEA (Failure Mode and Effects Analysis) applied to design and production to mitigate clinical risks.
Traceability: Full material lot tracking, process parameter logging, and batch records for recall readiness.
Process Validation: Validated injection molding, cleaning, and sterilization processes to ensure consistent quality.
Regulatory Compliance: Aligns with EU MDR, US FDA, and other global medical device regulations.
Surgical Instruments: Lightweight, sterilizable handles for forceps, scissors, and retractors (e.g., PEEK/PC blends for strength and chemical resistance).
Minimally Invasive Devices: Catheter hubs, trocar components, and endoscope housings (biocompatible TPE/PP for flexibility and leak-proof seals).
Implantable Accessories: Guidewire components, suturing device parts (PEEK for biostability and radiolucency).
Disposable Surgical Kits: Syringe plungers, drug delivery components, and wound closure device parts (medical-grade PP/PE for single-use sterility).
Material Selection: Use certified medical-grade plastics with USP Class VI/ISO 10993 test reports (biocompatibility, cytotoxicity, hemocompatibility).
Cleanroom Production: Manufactured in ISO 8 (Class 100,000) cleanrooms to avoid particulate contamination.
Precision Molding: High-tolerance tooling (S136 steel) with CMM inspection for critical dimensions (±0.005 mm).
Sterilization Validation: Validated cycles for autoclave (121°C/15 min), EO gas, or γ radiation (25–40 kGy) to ensure sterility assurance level (SAL) of 10⁻⁶.
Traceability System: Unique batch codes link each part to raw materials, production parameters, and inspection records.
Audit & Certification: Annual ISO 13485 surveillance audits; documentation of design controls, risk management, and corrective/preventive actions (CAPA).
Material: Medical-grade PEEK (biocompatible, high strength, heat-resistant).
Tolerance: ±0.01 mm on grip dimensions for secure instrument attachment.
Surface Finish: Ra≤0.1 μm (electrolytic polish) to prevent bacterial adhesion.
Sterilization: Autoclave-compatible (134°C/3 min) for repeated use.
Compliance: ISO 13485, FDA 21 CFR Part 820, USP Class VI.
Request a valid ISO 13485 certificate from the manufacturer (check accreditation body and expiration date).
Review material test reports (USP Class VI/ISO 10993) and sterilization validation records.
Confirm the manufacturer has a traceability system and documented risk management processes (per ISO 14971).
