How to choose medical-grade silicone tubing?
Views: 0 Author: Kevin Publish Time: 2025-07-29 Origin: Jinan Chensheng Medical Technology Co., Ltd.
Selecting the right medical-grade silicone tubing is a critical decision that directly impacts patient safety, device performance, and regulatory compliance. With applications ranging from drug delivery and surgical procedures to diagnostic equipment, medical-grade silicone tubing must meet stringent standards for biocompatibility, durability, and precision. As a leading China-based medical-grade silicone tubing manufacturer, Jinan Chensheng Medical Technology Co., Ltd. (www.jngxj.cn) combines decades of expertise with ISO 13485/FDA certifications to help buyers navigate this complex selection process. In this guide, we break down the key factors to consider when choosing medical-grade silicone tubing—and explain why partnering with a trusted manufacturer ensures optimal results.
1. Compliance: Prioritize Certifications and Regulatory Standards
Medical-grade silicone tubing is not just a component—it’s a critical medical device material. To ensure safety and legality, verify that the tubing meets global regulatory standards:
ISO 13485: Mandatory for manufacturers of medical devices, ensuring consistent quality management systems.
FDA 21 CFR 177.2600: Confirms suitability for food and medical contact, with strict limits on extractables and leachables.
USP Class VI: Validates biocompatibility for long-term implantation and critical applications.
EU MDR (2017/746): Essential for access to European markets, requiring rigorous clinical evaluation.
Why Chensheng Medical? Our tubing undergoes third-party testing to meet all these standards, with full documentation packages available for regulatory submissions. We are certified as a "High-Tech Enterprise" by China’s Ministry of Science and Technology, ensuring adherence to global best practices.
2. Durometer: Match Hardness to Application Requirements
Durometer (Shore A hardness) determines tubing flexibility, kink resistance, and grip—critical for device functionality:
Soft tubing (30–50 Shore A): Ideal for peristaltic pumps and neonatal care, where flexibility prevents tissue irritation.
Medium tubing (50–70 Shore A): Versatile for general-purpose applications like IV lines and respiratory circuits.
Hard tubing (70–80 Shore A): Suitable for high-pressure systems (e.g., surgical suction) and rigid catheter shafts.
Pro Tip: Softer tubing offers better kink resistance but may collapse under high vacuum. For complex devices, consult with manufacturers to balance hardness and performance.
Our Capability: We produce tubing with durometer ranging from 30–80 Shore A, with custom formulations available for specialized needs (e.g., ultra-soft 20 Shore A for neonatal catheters).
3. Reinforcement: Enhance Strength for High-Pressure Environments
Unreinforced tubing may fail in high-pressure or repetitive-flex applications. Reinforcement options include:
Braided polyester/nylon: Boosts burst pressure resistance (up to 300 psi) for surgical suction and hemodialysis.
Spiral steel: Prevents kinking in respiratory circuits and robotic surgical tools.
Fiber mesh: Improves dimensional stability in peristaltic pump tubing, ensuring consistent flow rates.
Application Example: Cardiac surgery requires braided tubing to withstand 250+ psi during bypass procedures—our reinforced tubing meets this demand with 10,000+ flex cycles without degradation.
4. Dimensions: Precision in Inner/Outer Diameter and Wall Thickness
Inner Diameter (ID): Directly impacts flow rate. For drug infusion, even 0.1mm deviations can alter dosage accuracy.
Outer Diameter (OD): Ensures compatibility with connectors, pumps, and catheter hubs.
Wall Thickness: Determines pressure resistance. Thicker walls (≥0.5mm) are critical for high-pressure applications like angiography.
Our Precision: Using automated extrusion lines with laser diameter control (±0.02mm tolerance), we produce tubing with ID 0.3mm–50mm and OD 0.5mm–60mm, with custom wall profiles (tapered, stepped) for specialized devices.
5. Color Coding: Improve Safety and Workflow Efficiency
Color coding minimizes errors in fast-paced clinical settings:
Patient-specific lines: Red for arterial, blue for venous, yellow for epidural.
Drug compatibility: Purple for chemotherapy, green for antibiotics.
Size differentiation: Color-coded stripes for quick identification of ID/OD in multi-line procedures.
Customization: We offer Pantone-matched pigments with MOQ 500 meters per color, plus laser marking (for part numbers/lot codes) to support your color-coding protocols.
6. Chemical Resistance: Protect Against Fluids and Sterilants
Medical tubing contacts aggressive substances, including:
Drugs: Chemotherapy agents (e.g., cisplatin), anticoagulants (heparin).
Disinfectants: Hydrogen peroxide, peracetic acid.
Bodily fluids: Blood, saliva, gastric juices.
Testing Data: Our platinum-cured silicone shows <0.1% weight loss after 30-day immersion in:
70% ethanol
10% sodium hypochlorite
pH 1–14 solutions
This ensures no leaching or degradation in critical applications.
7. Sterilization Compatibility: Ensure Long-Term Performance
Medical tubing must withstand repeated sterilization without losing integrity:
Autoclaving: Validated for 50+ cycles at 134°C (ISO 17665 compliant)
ETO Sterilization: Meets ISO 11135 requirements with <10 ppm residual ethylene oxide
Gamma Radiation: Stable up to 50 kGy (AAMI TIR17 standards)
Our Guarantee: Full sterilization validation reports available for regulatory submissions.
Why Partner with Chensheng Medical for Medical-Grade Silicone Tubing?
As a professional manufacturer with 5,000㎡ Class 8 cleanroom facilities and 20+ extrusion lines, we offer:
Comprehensive Product Range
From reinforced surgical tubing to radiopaque catheter shafts, we cover all medical applications—backed by batch-specific test reports (sterility, biocompatibility, dimensional accuracy).
OEM/ODM Expertise
Rapid Prototyping: 7–10 day turnaround for custom designs, with in-house mold fabrication.
Tooling Support: 50% mold cost reimbursement for orders ≥10,000 meters.
End-to-End Service: Material selection, design optimization, and regulatory documentation (e.g., DMF for FDA 510(k) submissions).
Production Capacity
With monthly output of 100,000+ meters, we ensure on-time delivery even for large-scale orders, supported by a 98% on-time shipment rate over 5 years.
Ready to Source the Perfect Medical-Grade Silicone Tubing?
Choosing the right medical-grade silicone tubing requires expertise—let our team of 15+ medical device engineers guide you. Whether you need standard products or custom OEM/ODM solutions, we deliver quality, compliance, and cost-efficiency.
Take Action Today:
Visit www.jngxj.cn to download our tubing specification catalog and certification package.
Send your requirements (application, dimensions, quantity) to info@jngxj.cn for a personalized quote within 24 hours.
Connect via WhatsApp: +8613256790045 for immediate technical support.
Your trusted partner for medical-grade silicone tubing—where precision meets patient safety.
