Everything About Medical Grade Silicone Is Here
Medical grade silicone states the class of silicone that has gone through rigorous clinical testing meeting the USP standards and is termed as a product that is safe to interact with the living tissues in a medical setting without causing any toxicity to the patient. Approved by Food and Drug Regulatory Authority (FDA), medical grade silicone is used to engineer a range of medical items like implants, gel sheets, tubes, etc. [1]
In terms of its medical applications, medical grade silicone can be classified as non-implantable (cannot be implanted in the human body), short-term implantable (applications limited to skin contact), and long-term implantable (can be used for 29 days or even life-long inside human body) [2].
Why is Silicone Used in Medical Applications?
We have already discussed about the merits of silicone. But when it comes to medical application, medical grade silicone has even more edges than other materials. Medical grade silicone is a synthetic polymer offering a wide range of benefits, which make it a perfect material for various medical silicone products. Let us explore those properties in detail:
Biocompatibility
A property expected from any medical grade material is its compatibility with the human tissue. Medical silicone is the epitome of biocompatibility as it is non-reactive in its interaction with the patient’s body, causing no allergic reaction, irritation, or infection resisting any kind of bacterial growth, a critical feature for medical applications [1].
Non-adhere to body tissue
Medical grade silicone shows resistance towards adherence to human body tissue, a critical and indispensable feature for both short-term and long-term implantable silicone. Imagine what would have happened if the material implanted into your body “grows” to be part of yours!
Easy to sterilize
Medical grade silicone is very easy to sterilize as it can tolerate common sterilization procedures without being degraded such as autoclaving, dry heat, rubbing with alcohol, radiations, etc. [4]
Proves to be a safe/sterile alternative to latex
Due to its chemical inertness and non-allergic features, medical silicone proves to be a safe/sterile alternative to latex that may cause allergic reactions in many people. For example, some people are found with latex allergies when, tragically, they are in contact with latex pacifiers as babies! A silicone baby pacifier would see no such issue.
Excellent transparency
Medical grade silicone possesses excellent transparency, allows illumination and transmission of light, a feature suitable for various medical applications involving endoscopes, optical sensors, etc.
Able to function in extreme temperatures
Another remarkable property of medical grade silicone is its endurance to a high temperature ranging from -75˚F to 500˚F [3]. For medical products that need to be constantly sterilized through high temperatures, silicone is just perfect for the case.
Good gas permeability, high elongation, and great dielectricity
Medical grade silicone offers high elongation (high tensile strength), and great dielectricity, making it a good insulator, and having good gas permeability makes it an impeccable material for medical applications.
Considering all these fascinating, FDA-approved features, medical grade silicone is truly the best material for your medical tubings, implants, and other medical silicone products, which you can get from XHF in the best quality.
Conclusion
XHF has been a trustworthy manufacturer providing a wide range of medical grade silicone products. For over two decades, we have been offering professional products and satisfactory services to its clients using 100% medical-grade silicone material free of BPA or lead. If you want specific types of medical grade silicone products uncommon on the market, customization is also a viable option here.
If you have any question regarding our product, manufacturing process or customization requirement, just send us an inquiry, we are always delighted to help you out in every possible way!
References
- The Health Board. What is medical grade silicone?. Markley. J. 2022.
- The growth of biocompatible silicone in implantable medical devices. Impact Networking. 2016.
- Apple Rubber. Medical grade silicone: What makes it safe for the medical field? Apple Rubber. 2020.
- How to clean medical grade silicone.