Precision TPU Tubing
for Life-Saving Medical Applications
ISO 13485 certified, biocompatible thermoplastic polyurethane tubing manufactured in a 100,000-level cleanroom — engineered to meet the most demanding healthcare standards.
Medical Grade
Biocompatible
Cleanroom Mfg
Full Traceability
What Is Medical-Grade TPU Tubing?
Medical-grade TPU (Thermoplastic Polyurethane) tubing is a high-performance, flexible polymer tubing specifically formulated and manufactured for healthcare and life science applications. Unlike standard PVC or silicone tubing, our TPU tubing combines exceptional clarity, superior mechanical strength, kink resistance, and biocompatibility — all without the use of plasticizers or phthalates.
At Shanghai Functech Tech, we extrude TPU tubing in an ISO Class 8 (100,000-level) cleanroom environment under strict ISO 13485 quality management protocols. Every batch is traceable from raw resin to finished product, with full documentation packages available for your regulatory submissions.
Our medical TPU tubing is trusted by medical device manufacturers worldwide for applications ranging from intravenous (IV) infusion and catheter systems to respiratory devices, surgical instruments, and diagnostic equipment.
Key Differentiators
- ISO 13485:2016 Certified Production
- 100,000-Level (ISO 8) Cleanroom
- USP Class VI Biocompatibility
- DEHP-Free & Phthalate-Free
- Full Lot Traceability
- Sterilization Compatible (EtO, Gamma, E-beam)
- Custom Formulations Available
Why Medical Device Manufacturers Choose Our TPU Tubing
Every meter of tubing we produce is backed by rigorous quality control and designed to perform in critical healthcare environments.
ISO 13485 Certified
Our entire production process — from incoming resin inspection to final packaging — adheres to ISO 13485:2016 medical device quality management standards. Full DMR and DHR documentation available.
USP Class VI Biocompatible
Our medical-grade TPU formulations pass USP Class VI and ISO 10993 biocompatibility testing, including cytotoxicity, sensitization, and intracutaneous irritation — safe for prolonged patient contact.
Superior Kink Resistance
Engineered with optimized Shore hardness (70A–95A) and wall thickness ratios to prevent lumen occlusion during bending — critical for catheter, infusion, and peristaltic pump applications.
Crystal-Clear Transparency
Excellent optical clarity enables visual fluid monitoring — essential for IV lines, drainage tubes, and diagnostic equipment. Haze levels consistently below 3% across all wall thicknesses.
Sterilization Compatible
Fully compatible with all major sterilization methods: EtO (Ethylene Oxide), Gamma irradiation, and E-beam. No significant change in mechanical properties or clarity post-sterilization.
DEHP-Free & Safe
Unlike PVC tubing, our TPU contains NO plasticizers, phthalates (DEHP, DINP), BPA, or latex. 100% safe for sensitive medical applications including neonatal and pediatric care.
TPU Tubing in Healthcare: Where Precision Matters Most
From the operating room to home-care devices, our TPU tubing is engineered for the medical applications where failure is not an option.
IV Infusion & Transfusion Lines
Crystal-clear, flexible tubing for intravenous drug delivery, blood transfusion, and parenteral nutrition. Excellent flow consistency and minimal leaching.
Catheters & Cannulae
Multi-lumen and single-lumen catheter tubing with excellent torque response, pushability, and kink resistance for cardiovascular, urological, and neurovascular procedures.
Respiratory & Anesthesia Circuits
Lightweight, flexible tubing for ventilators, CPAP/BiPAP machines, anesthesia delivery, and oxygen therapy with excellent gas barrier properties.
Surgical Drainage Systems
Transparent, non-adherent wound drainage tubing with smooth inner lumen to prevent clot formation and ensure consistent negative pressure.
Laboratory & Diagnostic Equipment
Peristaltic pump tubing, sample transfer lines, and fluidic pathways for blood analyzers, chromatography, and immunoassay instruments. Excellent chemical resistance.
Enteral Feeding & Nutrition
Soft, flexible feeding tubes and extension sets with smooth tips for patient comfort. Biocompatible formulation safe for prolonged mucosal contact.
Dental & Ophthalmic Devices
Micro-bore precision tubing for dental irrigation, suction, and ophthalmic surgical systems requiring ultra-smooth inner surfaces and precise dimensional control.
Dialysis & Blood Processing
High-purity tubing for hemodialysis blood lines and apheresis systems. Exceptional hemocompatibility with minimal platelet adhesion and hemolysis.
Medical Certifications & Compliance
Our medical-grade TPU tubing meets the most stringent international standards for healthcare applications.
ISO 13485:2016
Medical Device QMS
USP Class VI
Highest Biocompatibility Rating
ISO 10993
Biological Evaluation of Medical Devices
FDA 21 CFR
Drug & Device Master File Available
ISO 9001:2015
Quality Management System
REACH Compliant
EU Chemical Safety Regulation
RoHS Compliant
Hazardous Substances Free
EU MDR Ready
European Medical Device Regulation
Why a 100,000-Level Cleanroom Matters for Medical Tubing
Medical device manufacturing demands an environment free from particulate contamination. Our ISO Class 8 (Class 100,000) cleanroom — compliant with ISO 14644-1 standards — ensures that every meter of TPU tubing is extruded, cut, and packaged under controlled conditions.
Within our cleanroom, we maintain strict control over airborne particle counts (≤ 3,520,000 particles ≥ 0.5 µm per cubic meter), temperature (22°C ± 2°C), humidity (45% ± 10% RH), and positive air pressure to prevent external contamination ingress.
- HEPA-filtered air circulation systems
- Continuous particle count monitoring
- Full gowning protocols (ISO Class 8)
- Antistatic flooring and work surfaces
- Scheduled environmental bioburden testing
- Segregated raw material and finished goods zones
- Validated cleaning and disinfection SOPs
- Personnel training and hygiene compliance logs
Technical Specifications
All parameters can be customized. Contact our medical division for your specific requirements.
| Parameter | Standard Grade (XG-M75) | High-Flex Grade (XG-M85) | Rigid Grade (XG-M95) |
|---|---|---|---|
| Physical & Mechanical Properties | |||
| Shore Hardness | 75A | 85A | 95A |
| Inner Diameter (ID) | 0.5 – 25.0 mm | 0.5 – 25.0 mm | 0.5 – 20.0 mm |
| Outer Diameter (OD) | 1.0 – 30.0 mm | 1.0 – 30.0 mm | 1.0 – 25.0 mm |
| Wall Thickness | 0.25 – 3.0 mm | 0.25 – 3.0 mm | 0.25 – 2.5 mm |
| Tolerance (OD/ID) | ±0.05 mm | ±0.05 mm | ±0.05 mm |
| Tensile Strength | ≥ 30 MPa | ≥ 35 MPa | ≥ 40 MPa |
| Elongation at Break | 500% – 700% | 450% – 600% | 350% – 500% |
| Kink Radius | ≤ 3 × OD | ≤ 2.5 × OD | ≤ 2 × OD |
| Biocompatibility & Safety | |||
| USP Class | Class VI | Class VI | Class VI |
| ISO 10993 | Part 5, 10, 11 | Part 5, 10, 11 | Part 5, 10, 11 |
| Hemolysis Index | < 2% | < 2% | < 2% |
| DEHP / Phthalates | None | None | None |
| Latex-Free | Yes | Yes | Yes |
| Sterilization & Processing | |||
| EtO Sterilization | Compatible | Compatible | Compatible |
| Gamma Irradiation | Up to 50 kGy | Up to 50 kGy | Up to 50 kGy |
| E-beam | Compatible | Compatible | Compatible |
| Autoclave (121°C) | Not Recommended | Not Recommended | Limited Cycles |
| Bonding Method | Solvent / UV / RF | Solvent / UV / RF | Solvent / UV / RF |
| Packaging & Delivery | |||
| Cut Length | Custom (50 mm – coils) | Custom (50 mm – coils) | Custom (50 mm – coils) |
| Packaging | Cleanroom PE bag, spool | Cleanroom PE bag, spool | Cleanroom PE bag, spool |
| MOQ | 1,000 m per spec | 1,000 m per spec | 1,000 m per spec |
| Lead Time | 10–20 business days | 10–20 business days | 10–20 business days |
Our Medical Tubing Quality Process
From resin to delivery — every step is documented, validated, and traceable.
Resin Qualification
Incoming resin inspection, biocompatibility verification, lot traceability
Cleanroom Extrusion
ISO Class 8 environment, laser OD/ID gauging, real-time SPC monitoring
In-Process QC
Visual inspection, dimensional checks every 30 min, burst pressure testing
Lab Testing
Tensile, elongation, kink radius, clarity, USP & ISO 10993 biotesting
Cleanroom Packaging
Double-bagged in ISO 8 cleanroom, labeled with full traceability data
Final Release
Batch record review, COA issuance, sterilization validation certificate
What Our Medical Device Partners Say
Trusted by medical device manufacturers across 60+ countries.
“We switched to Functech’s medical-grade TPU tubing for our IV infusion sets two years ago. The consistency in wall thickness and clarity is outstanding. Their ISO 13485 documentation package made our FDA 510(k) submission seamless.”
“After evaluating five suppliers across Asia, Functech was the only one that could provide both the cleanroom manufacturing environment AND the biocompatibility data we required. Their technical support team helped us refine our catheter design with custom hardness profiles.”
“The kink resistance of their 85A tubing solved our biggest perfusion pump challenge. Batch-to-batch consistency is excellent — we’ve seen less than 0.5% dimensional variation across 200+ production batches.”
Frequently Asked Questions
Common questions about our medical-grade TPU tubing.
Do you provide regulatory documentation for medical device registration?
Yes. We provide a comprehensive documentation package including ISO 13485 certificate, USP Class VI test reports, ISO 10993 biocompatibility data, raw material certifications, Device Master Record (DMR), and a Certificate of Analysis (COA) with every batch. We can also support Drug Master File (DMF) or Device Master File (MAF) submissions to the FDA upon request.
Can you customize the tubing formulation for specific medical applications?
Absolutely. Our in-house R&D team can tailor TPU formulations to meet your specific requirements — including radiopacity (barium sulfate or tungsten filled), antimicrobial additives, color coding, co-extruded stripe tubing, and specific hardness ranges. We also offer multi-lumen and braid-reinforced tubing options.
What is the minimum order quantity for medical tubing?
Our standard MOQ is 1,000 meters per specification. However, we understand that medical device development often requires smaller quantities for prototyping and clinical trials. We offer low-volume R&D runs (from 100 meters) with expedited lead times for qualified medical device partners.
How do you ensure lot-to-lot consistency for medical applications?
We maintain strict change control procedures and validate every new resin lot before production use. Our extrusion lines are equipped with laser OD/ID gauges that monitor dimensions in real-time, and SPC (Statistical Process Control) data is recorded continuously. Each production batch undergoes mechanical property verification before release.
Ready to Elevate Your Medical Device with Premium TPU Tubing?
Whether you are developing a new medical device or seeking a reliable tubing partner for existing production, our team is ready to support you with free samples, technical consultation, and full regulatory documentation.
Free Samples · Technical Consultation · Full Regulatory Support · Fast Quotation