Medical-Grade TPU Film for Blood Pressure Cuffs & Air Bladders
ISO 9001 certified TPU films for blood pressure cuffs & airbags. Latex-free material supports your ISO 10993 compliance. Durable & sterilizable.
Introduction
Medical devices impose extremely stringent requirements on material safety, reliability, and stability. Components such as blood pressure cuffs, physical therapy airbags, and compression sleeves come into direct contact with patients' skin, necessitating materials that are absolutely flawless.
As an ISO 9001:2015 (GB/T 19001-2016) certified manufacturer, GREEN TPU specializes in producing high-performance TPU films for medical applications. Unlike traditional PVC or Latex, our materials offer superior durability, hypoallergenic properties, and resistance to repeated sterilization cycles. We support medical device manufacturers (OEMs) with consistent, traceable, and safe materials.
Core Advantages of Our TPU Film for Medical Use
Why are leading medical brands switching to TPU? Here is how we solve the critical pain points in clinical applications:
1. Proven Biocompatibility & Safety Record
Pain Point: Medical OEMs worry that raw materials might fail cytotoxicity or irritation tests, delaying product launch.
Our Solution: We use high-purity, 100% Latex-Free and Phthalate-Free raw materials. Validated Success: Many of our downstream clients have successfully obtained ISO 10993 certification for their finished devices using our TPU films. This proven track record demonstrates that our material formulation is safe and supports your regulatory approval process.
2. High Tensile Strength & Cycle Durability
Pain Point: Blood pressure cuffs endure tens of thousands of inflation and deflation cycles. Material fatigue can lead to leaks, resulting in inaccurate readings or sudden device failure.
Our Solution: Our TPU film exhibits exceptional tensile strength and tear resistance. It withstands repeated compression, folding, and high-pressure inflation without deforming, ensuring the measurement accuracy and reliability of the device throughout its entire lifecycle.
3. Chemical Resistance & Sterilizability
Pain Point: Medical environments require frequent cleaning with disinfectants (alcohol, bleach) and rigorous sterilization procedures, which degrade standard plastics.
Our Solution: GREEN TPU films exhibit excellent resistance to common chemical disinfectants. The material is robust enough to withstand mainstream sterilization methods without cracking or yellowing, ensuring hygienic safety.
4. Low-Noise Operation for Patient Comfort
Pain Point: The friction noise ("crinkling" sound) from stiff materials during inflation can cause anxiety or discomfort for patients, particularly in quiet hospital wards.
Our Solution: Our TPU material is inherently soft with a specially engineered surface texture. It produces minimal friction noise during movement, delivering a more comfortable and quieter medical experience.
Application Scenarios: Precision Medical Components
Our films are engineered for High-Frequency (HF) welding manufacturing processes. Below are the key applications:
| Medical Application | Material Solution & Value |
|---|---|
| Blood Pressure Cuffs (NIBP) | Requirement: Airtightness & Durability. Solution: Our films ensure a consistent air seal for accurate pressure readings and withstand constant velcro abrasion and folding. |
| Physical Therapy & Rehab Airbags | Requirement: Burst Strength. Solution: High-strength TPU allows for high-pressure inflation in massage chairs or limb compression sleeves without rupturing. |
| Antithrombotic Pressure Pumps (DVT) | Requirement: Long-term Skin Contact. Solution: Soft-touch, breathable TPU texture prevents maceration and irritation during extended post-operative wear. |
| Medical Splints & Immobilization | Requirement: Rigidity after inflation. Solution: Vacuum-retention TPU films that mold perfectly to the patient's limb shape for effective stabilization. |
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| Blood Pressure Cuff | Airbags for Physical Therapy and Rehabilitation Equipment | |
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| Antithrombotic Pressure Pump | Medical Splints and Immobilization Devices | |
Technical Deep Dive: Manufacturing Quality
For medical device engineers, process stability is as important as material performance. Our ISO 9001:2015 system ensures:
1. Strict Quality Control & Traceability
Under our GB/T 19001-2016 / ISO 9001:2015 certified system, every roll of film is fully traceable.
- Lot Traceability: From raw resin pellets to the final slit roll, ensuring accountability.
- Consistency: Automated gauge controls ensure thickness uniformity (±0.005mm), critical for consistent inflation rates in air bladders.
2. Advanced Welding Compatibility (HF Welding)
TPU is the "Gold Standard" for High-Frequency (Radio Frequency) welding. Unlike other plastics that require adhesives, TPU molecules fuse instantly under HF energy.
- Seam Strength: The welded seam is as strong as the film itself.
- Leak-Proof: Creates a hermetic seal essential for air bladders.
Material Comparison: Why TPU is the Better Choice
The medical industry is upgrading from PVC and Latex to TPU. Here is the technical breakdown of why TPU is the superior choice:
| Performance Criteria | Comparison: TPU vs. PVC/Latex |
|---|---|
| Allergen Risk (Safety) | TPU Advantage: 100% Latex-Free and Phthalate-Free composition. Legacy Flaw: Latex carries high allergy risks; PVC often contains toxic plasticizers. |
| Durability & Aging | TPU Advantage: Excellent flex fatigue resistance; does not harden over time. Legacy Flaw: PVC hardens or cracks due to plasticizer migration; Latex degrades rapidly. |
| Environmental Impact | TPU Advantage: Recyclable and incineration-safe (no toxic fumes). Legacy Flaw: PVC releases dangerous chlorine gas when burned; difficult to dispose of sustainably. |
| Tactile Comfort | TPU Advantage: Dry, soft, matte finish prevents sticking to skin (tack-free). Legacy Flaw: Often feels clammy or sticky against the skin, causing patient discomfort. |
Factory Capabilities: Tailored for OEMs
We understand that medical device validation is rigorous. GREEN TPU supports your R&D and production with:
- Surface Textures:
- Matte Finish: Reduces surface friction and sticking for skin-contact parts.
- Glossy Finish: High clarity for internal bladders requiring visual inspection. - Precision Extrusion: Thickness range from 0.03mm to 3mm with strict tolerance control.
- Clean Manufacturing: Produced in controlled environments to minimize particulate contamination.
Conclusion
In the medical field, material failure is not an option. GREEN TPU provides the safe, durable, and consistent films required for critical healthcare applications. With a material formulation validated by downstream ISO 10993 certifications, we help device manufacturers reduce compliance risks and accelerate time-to-market.
