Understanding the differences between medical grade silicone and food grade silicone can help you produce compliant silicone products and avoid liability claim risks. This article will introduce the differences between the two from multiple aspects, like compliance certification, properties, processing costs, to help you make the right choice.
What is Medical Grade Silicone?
Medical grade silicone is a specially refined grade of silicone specifically designed for medical applications.It offers excellent biocompatibility and can be used in applications involving direct or indirect contact with human tissue, depending on the specific certification level.
Applications
Surgical Implants and Medical Devices
You can use it for catheters, implants, pacemaker accessories. It remains stable within the human body and has no adverse reactions. It can maintain its performance for a long time.
Wound Care and Medical Bandages
If you make it into a wound dressing or medical bandage, it is suitable because medical grade silicone is gentle and non-irritating to the skin, comfortable to wear, and easy to remove.
Respiratory and Anesthesia Equipment
You can also apply medical grade silicone to respiratory masks, anesthesia components, ventilator masks and other devices, meeting aseptic requirements and meeting the compatibility requirements of human tissues.
What is Food Grade Silicone?
Food grade silicone is a silicone material specifically designed for food-contact applications and compliant with food safety regulations. Due to its non-toxic and odorless nature, it can directly come into contact with food and the mouth.
It also has the advantages of excellent heat resistance and stable structural strength. Therefore, it does not deteriorate easily in a wide temperature range and will not release harmful substances even under extreme conditions.
Applications
Baking and Cooking Utensils
You can make food grade silicone into baking molds, spatulas, pastry brushes and other kitchen utensils. It has excellent heat resistance and ensures a safe and stable cooking process throughout the entire baking procedure. It performs reliably.
Food Storage Supplies
If food grade silicone is used to make the storage box, the sealing lid and the sealing accessories, it can ensure that they are non-toxic and do not cause food odors to transfer. Moreover, they can be reused, which can not only keep the freshness of the ingredients but also prevent food from being contaminated, thus attracting more consumers.
Baby and Maternity Products
Silicone itself does not contain bisphenol A. Food grade silicone is commonly used for baby products because it meets food-contact safety standards. Therefore, it can be used to make baby bottles, complementary food utensils, and teething toys, making your customers feel more at ease when choosing and using these products.
Differences Between Medical Grade and Food Grade Silicone
Certification and Compliance Standards
The most significant difference between medical grade silicone and food grade silicone lies in the aspect of compliance certifications. Medical-grade silicone must pass two mandatory tests: biocompatibility and cytotoxicity. Food-grade silicone, on the other hand, only needs to meet the basic migration test.
After completing the product certification, you also need to pay attention to the issue of batch traceability. Medical products implement strict batch traceability control, while food grade products adopt conventional batch management.
Medical Grade
The table below lists the relevant certification standards that you can refer to when manufacturing medical grade silicone products:
| Certifications / Standards | Description |
| ISO 10993 | Biological evaluation of medical devices (cytotoxicity, sensitization, intracutaneous reaction, systemic toxicity, etc.) |
| USP Class VI | Highest level biocompatibility test of United States Pharmacopeia |
| ISO 13485 | Quality management system for medical devices (manufacturing specifications) |
| FDA 510(k) | Premarket notification for US medical devices (partial products) |
| CE MDR | EU Medical Device Regulation Certification |
| GMP | Good Manufacturing Practice (requirements for sterile / clean workshop) |
Food Grade
Although the food grade silicone certification is not as strict as the medical grade silicone, the entry requirements vary from region to region. You can refer to the following table:
| Certifications / Standards | Description |
| FDA 21 CFR 177.2600 | US standard for food contact materials |
| LFGB | Safety standard for food contact materials in Germany and EU |
| EU 10/2011 | EU regulation for food-contact plastics and silicone |
| GB 4806.11-2016 | National food safety standard of China for silicone materials |
Physical and Chemical Properties
There are significant differences in performance between medical grade and food grade silicone.
Mechanical Properties
From the perspective of mechanical properties, medical-grade silicone has a higher tensile strength and excellent tear resistance.
If you need it for applications such as silicone tubes and implants, medical grade silicone not only allows for customization of its softness, but also has good resilience and low permanent compression deformation, meeting your requirements. Food grade silicone only needs to meet daily usage needs, with moderate softness and good mechanical properties.
Temperature Resistance
The temperature resistance of silicone and its sterilization application are related to each other. Both medical grade and food grade silicone offer excellent temperature resistance. The exact temperature range depends more on the silicone formulation than on the grade itself.
However, medical grade silicone can withstand steam, gamma rays, and ethylene oxide sterilization, easily meeting the medical aseptic standards you require. Food grade silicone does not need long-term high-pressure sterilization and is not typically subjected to be treated with irradiation or ethylene oxide sterilization.
Purity and Safety
When making your purchase, you should also pay attention to the differences in the purity of the silicone. Because medical grade silicone does not contain harmful ingredients and strictly controls the residual small molecules, the residual heavy metals are almost zero, and the content of precipitates and volatiles is extremely low.
While food grade silicone has set relevant substance content limits, the review standards are less stringent, and stabilizers and color masterbatches can be added appropriately during production. Compared between the two, medical grade silicone is safer.
Production Process and Cost
Distinguishing the differences between the two types of silicone production processes and cost can help you make better decisions when selecting materials for procurement.
In general, medical grade silicone has higher standards throughout the entire process, from raw materials, manufacturing, to packaging upon leaving the factory. If your factory meets the production requirements for daily civilian products, food grade silicone has a simpler and more compliant process, making it more suitable for you.
Raw Materials
At the raw material level, medical grade silicone is preferably made from imported high-purity silicone rubber. For food grade silicone, either domestic or imported high-purity raw materials can be used. This determines the cost of the raw materials. Imported high-purity silicone rubber is more expensive than domestic ones.
Production Conditions
The control of process parameters such as curing temperature and duration for medical grade silicone is more stringent. If you are going to produce products related to medical grade silicone, we recommend that you use liquid silicone or molding, and operate throughout in an ISO7 or higher sterile workshop.
The molding process for food grade silicone is the same as that for medical grade silicone, but the cleanliness standard of the production environment is lower. You can adopt conventional batch production.
Subsequent Processing
In terms of subsequent processing, medical products must undergo sterilization treatment with ethylene oxide, steam or radiation, and be packaged in aseptic sealed containers; for food grade products, sterilization is usually not necessary and conventional clean packaging is sufficient.
Therefore, the processes, time and packaging costs you incur for medical grade products are also higher than those for food grade products.
FAQ
Can Food Grade Silicone Replace Medical Grade Silicone?
Of course not. The certification standards for the two are different, and so are their applications. Moreover, the medical grade silicone certification is relatively strict, and food grade silicone cannot replace it.
Is Medical Grade Silicone Definitely Better in Quality Than Food Grade Silicone?
Not necessarily. Because medical grade and food grade refer to different application cases, not to distinguish the performance. The performance of silicone is determined by its formula.
How Much More Expensive Is Medical Grade Silicone Than Food Grade?
It is usually 30-100% more expensive, or even higher. This is because of factors such as raw materials, certification testing costs, production conditions, and packaging handling. Medical grade silicone is more expensive than food grade silicone.
Therefore, we recommend that you only use medical grade silicone when it is truly necessary. Using medical grade silicone unnecessarily increases costs without added benefit.
Can FDA Certified Silicone Meet Both Medical and Food Grade Standards?
No, because FDA certification for food-contact silicone and FDA clearance for medical devices belong to different regulatory frameworks and testing requirements. If your supplier only mentions FDA certification, you can ask the supplier to provide detailed test reports for the corresponding correct system.
Can Silicone Comply with Both Medical and Food Grade Standards?
It is possible, but the specific scope of medical grade compliance and food grade compliance needs to be verified. If the silicone you purchase has passed both ISO 10993 and FDA 21 CFR 177.2600, then it is acceptable.
Final Thoughts
Legensilico, as a silicone manufacturer with over 20 years of experience, can provide you with various types of medical grade and food grade silicone. If you are interested in our silicone and wish to further cooperate, please contact us.
