Medical silicone is a high-purity material that was specially developed for use in medical technology and in direct contact with the human body. Thanks to its high purity and biocompatibility, medical silicone meets the strict requirements of modern medical products and implants.
What is medical silicone rubber?
Medical silicone rubber is a biocompatible silicone material that, due to its special properties, is frequently used for implants, catheters and other demanding applications.
How is medical silicone structured?
The basis of medical silicone is high-purity PDMS, which is processed under cleanroom conditions and thoroughly tested for quality and biocompatibility.
What is the difference between food-grade and medical silicone?
Food-grade silicone is suitable for contact with food, while medical silicone is intended for use in the human body and is subject to stricter requirements for purity and safety.
What properties characterize medical silicone rubber?
Due to its temperature resistance, biocompatibility, chemical stability and sterilizability, medical silicone rubber is frequently used in medical products.
What applications and examples are there for medical silicone rubber?
Typical applications of medical silicone rubber include respirators, infusion tubes, catheters, prostheses and breast implants.
Medical silicone rubber is a silicone material developed specifically for use in the medical field.
The following explains the composition, properties as well as manufacturing and quality processes of medical silicone in more detail.
Note: Alongside classic medical silicone, intelligent material developments such as Smart Silicone are becoming increasingly important. Silicone is being developed into a platform for technical functions – far beyond classic applications such as sealing, damping or insulating.
Note: Silnova specialises in the “Near Medical” segment – that is, products and components that are applied on the body but not implanted in it. The actual cleanroom manufacturing is handled by our partner RAUMEDIC, which specialises in cleanroom solutions for medicine and pharmaceuticals.
Food-grade and medical silicone are both safe, non-toxic materials with high compatibility. The choice of the respective material depends heavily on the area of application and the requirements for safety and performance.
The most important difference lies in the respective quality and safety requirements as well as in the intended use and the associated limits of application.
The most important aspects of both types in detail:
Food-grade silicone is developed for contact with food and must above all meet the applicable food safety standards, while medical silicone is used directly on or in the human body. As a result, the testing procedures and purity requirements also differ significantly. Food-grade silicone is also cheaper than medical silicone.
Food-grade silicone is used primarily for kitchen and everyday products that come into contact with food. It is heat-resistant and remains stable in a temperature range of approximately -50 °C to 250 °C, which makes it particularly versatile in the household.
Medical silicone, on the other hand, is used for sensitive medical applications such as catheters, implants or wound products. Here, the highest purity, long-term biocompatibility and strict safety testing are the main priorities.
Food-Grade Silicone
Contact with food in everyday life
On or in direct contact with the body
e.g. FDA, LFGB
e.g. ISO 10993, USP Class VI
Focus on short-term safety
Strict biocompatibility and long-term tests
High, but less strictly controlled
Very high, almost free of impurities
Industrial production
Cleanroom and special processes
Baking molds, baby bottles, kitchen utensils
Catheters, implants, medical masks
Rather cheaper
Significantly more expensive due to higher requirements
Food-Grade Silicone
Medical Silicone
Area of application
Contact with food in everyday life
On or in direct contact with the body
e.g. FDA, LFGB
e.g. ISO 10993, USP Class VI
Testing requirements
Focus on short-term safety
Strict biocompatibility and long-term tests
High, but less strictly controlled
Very high, almost free of impurities
Manufacturing
Industrial production
Cleanroom and special processes
Baking molds, baby bottles, kitchen utensils
Catheters, implants, medical masks
Rather cheaper
Significantly more expensive due to higher requirements
The special material properties make medical silicone rubber the preferred choice for demanding applications in medical technology, prosthetics and high-quality medical products.
It remains elastic and stable in the range of approximately -60 °C to +270 °C, without losing its fundamental properties. The material also barely changes under humidity or strong temperature fluctuations. This stability is particularly important for medical components such as seals or instrument parts.
Medical silicone is resistant to body fluids and many chemicals. Neither blood, saliva nor other biological fluids significantly affect the material properties. This makes the material particularly suitable for applications with direct or long-term body contact.
Another advantage is the good compatibility with cleaning and sterilization processes. The material can be disinfected multiple times without losing quality. Due to its high purity and chemical stability, it offers germs only limited adhesion possibilities and thus reduces the risk of contamination.
Medical silicone also withstands intensive sterilization processes, such as UV light, ozone or other common methods. It remains dimensionally stable and functional even when treated frequently. This property makes it particularly suitable for medical products that must be cleaned regularly and safely reused.
Mixing the Components:
Liquid silicone consists of two components that are mixed together in a precise, fixed ratio before processing.
2.
Injection into the Mold (Injection Molding):
The mixed material is injected under low pressure into a specially prepared mold.
3.
Shaping and Vulcanization:
The silicone cures inside the mold. This chemical process is referred to as vulcanization and gives the component its final shape and stability.
4.
Demolding the Component:
After curing, the finished silicone part is removed from the mold.
5.
Thermal Post-Treatment (Tempering, optional):
If required, the parts are post-treated. This removes volatile residues and improves the material properties.
6.
Further Customization and Processing: Depending on the area of application, the component can subsequently be further processed or specifically adapted.
Medical silicone rubber is used in medicine in a variety of areas of application where safety, skin compatibility and reliability in direct contact with people are crucial.
Many medical technology companies rely on this material to manufacture high-quality and safe medical products. Depending on the application, the material is processed in different quantities, for example for small medical components or large-area implants.
Note: In addition to medical technology, medical silicone rubber is also used in general industrial sectors, for example in technical seals, tubes and molded parts.
Medical silicone is a specially manufactured material that was developed for use in the medical field. It usually consists of high-purity polydimethylsiloxane (PDMS). The material is particularly flexible, stable and well tolerated by the human body. That is why it is frequently used in products such as implants, catheters or medical masks.
Yes, medical silicone is considered very safe for use in the body and is preferred for aesthetic implants. It is biocompatible, meaning it generally does not trigger any allergic reactions or irritation. Before use, it is rigorously tested and must meet international safety standards. This ensures that it is suitable for medical applications.
The cost of medical silicone depends on the quality, purity and form of the material. It is generally more expensive than normal industrial silicone, as it has to be elaborately cleaned and tested. Processing and certification also increase the price. The price therefore varies significantly depending on the application and manufacturer. Depending on the area of use, for example with implants or special medical products, the requirements and thus also the costs can increase further.
“100% medical silicone” means that the material consists entirely of medically approved silicone. It contains no additional fillers or unsuitable additives. It also meets all requirements for purity and biocompatibility. Nevertheless, in everyday use the term is often promotional and should be confirmed by certifications such as ISO standards.
Medical silicone is characterized by high durability and resistance. The exact service life depends on the respective application, the environmental conditions and the stress on the material. With proper use, medical silicone can reliably retain its properties over many years. It is resistant to moisture, temperature fluctuations and many chemicals.
Silicon dioxide is an important raw material for the manufacture of medical silicone, as silicon is first obtained from it. This is then further processed into silicone polymers such as PDMS. The quality of the silicon dioxide influences the purity and performance of the final material. It thus contributes indirectly to the biocompatibility and safety of medical silicone products.
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