Views: 0 Author: Kevin Publish Time: 2025-12-24 Origin: Jinan Chensheng Medical Technology Co., Ltd.
In the medical industry, there is no room for error. Whether it is a catheter inserted into a patient or a hose transferring sterile vaccines, the materials used must meet the highest standards of purity and reliability.
Medical grade silicone tubing has become the gold standard in healthcare due to its unique combination of biocompatibility, flexibility, and chemical inertness. However, for device manufacturers and procurement officers, navigating the complex landscape of regulatory standards (like ISO and USP) can be challenging.
This article explores the critical requirements for medical silicone, its life-saving applications, and the certifications you must look for when sourcing Silicone Tubing.
Unlike industrial hoses, medical tubing interacts directly with the human body or sensitive fluids. Therefore, the material must possess specific characteristics:
Biocompatibility: The tubing must not trigger an immune response. High-quality medical silicone is hypoallergenic and non-toxic.
Purity (Platinum Cured): Medical tubing is almost exclusively platinum-cured. Unlike peroxide-cured options, platinum curing leaves no by-products, ensuring low extractables and leachables. This is crucial to prevent fluid contamination.
Sterilization Compatibility: Medical devices are sterilized repeatedly. Silicone can withstand Autoclave (steam), Gamma Radiation, and EtO (Ethylene Oxide) sterilization without losing its physical properties.
Transparency: Medical professionals often need to see the fluid flow. High-transparency silicone allows for easy visual monitoring.
From hospitals to pharmaceutical labs, custom silicone tubing is ubiquitous. Here are key areas where it is indispensable:
Silicone is the material of choice for peristaltic pumps used in dialysis machines and IV drips. Its superior elasticity allows it to recover its shape after thousands of hours of compression, ensuring precise dosing accuracy.
Because silicone is soft and flexible, it reduces trauma to sensitive tissues. It is widely used in urinary catheters, feeding tubes, and wound drainage systems where long-term patient comfort is essential.
In the production of vaccines and drugs, "single-use systems" are trending. Silicone tubing is used to transfer sterile media between bioreactors and storage bags, ensuring a closed, sterile environment.
Sourcing for a specific device?View our range of Medical Grade Silicone Tubing available in various shore hardnesses and sizes.
When selecting a supplier, "medical grade" is not just a marketing term—it must be backed by certifications.
Standard |
Description |
Why it Matters |
USP Class VI |
The strictest designation by the United States Pharmacopeia. |
Tests for toxicity in systemic and intracutaneous use. Essential for implants and invasive devices. |
ISO 10993 |
The global standard for biological evaluation of medical devices. |
Evaluates cytotoxicity, sensitization, and irritation. Required for CE marking in Europe. |
FDA 21 CFR 177.2600 |
Regulation for rubber articles intended for repeated use. |
While often associated with food grade silicone tubing, it is a baseline requirement for purity in medical contexts too. |
Note: Always request a Certificate of Compliance (CoC) and material test reports from your manufacturer.
The medical device industry is evolving, and silicone technology is advancing with it:
Antimicrobial Silicone: New formulations are embedding silver ions into the silicone matrix to prevent bacterial colonization on tube surfaces, reducing hospital-acquired infections.
Micro-Extrusion: As surgeries become less invasive, the demand for micro-bore silicone tubing (with diameters smaller than a needle) is skyrocketing for neurovascular applications.
Sustainable Manufacturing: There is a growing push for eco-friendly production processes that reduce waste during the extrusion of silicone products.
Choosing the right silicone tubing is a critical step in medical device design. It requires balancing mechanical performance (like pump life) with strict regulatory compliance (USP/ISO).
At JNGXJ, we understand these complexities. Whether you need standard sizes or custom silicone tubing designed for a specific medical device, our manufacturing processes ensure purity and precision.
Q: What is the difference between Medical Grade and Food Grade Silicone Tubing?A: While both are safe, medical grade silicone tubing undergoes more rigorous testing (like USP Class VI) for biocompatibility and implant safety. Food grade silicone tubing focuses on FDA 21 CFR 177.2600 compliance to ensure it doesn't alter the taste or smell of food.
Q: Can medical silicone tubing be reused?A: Yes, silicone is highly durable and can be sterilized via autoclave multiple times. However, for many medical applications, single-use tubing is preferred to eliminate the risk of cross-contamination.
Q: What is "Platinum Cured" silicone?A: Platinum curing is a chemical process used to solidify the silicone. It is preferred for medical applications because it does not produce by-products (unlike peroxide curing), resulting in a clearer, purer, and stronger tube.
Q: Do you offer custom sizes for medical devices?A: Yes, we specialize in custom silicone tubing. We can extrude tubing to tight tolerances with specific Inner Diameters (ID), Outer Diameters (OD), and wall thicknesses to fit your medical equipment perfectly.
