Food-grade silicone and medical-grade silicone are both platinum-cured silicone, highly regarded for their excellent performance and wide range of applications. However, these two types of silicone have significant differences in their practical applications. This article will delve into the differences between food-grade silicone and medical-grade silicone in terms of definitions, industry standards, material purity, application fields, and price differences.
1. Basic Definitions
Food-Grade Silicone: Also known as FDA silicone, this type of silicone meets food safety standards. It must pass rigorous testing to ensure it does not release harmful substances under high or low temperatures. Food-grade silicone is typically certified by regulatory bodies, with globally recognized agencies including the U.S. Food and Drug Administration (FDA), the EU regulatory framework for silicones, and the European Commission's decisions on silicones.
food grade silicone mold
Medical-Grade Silicone: This is a non-toxic and inert synthetic elastomer that must undergo biocompatibility testing to ensure safety and stability when in contact with human tissues and fluids. Medical-grade silicone is usually categorized into three types: non-implantable, short-term implantable, and long-term implantable.
- Non-Implantable: Devices used for contact with skin, mucous membranes, or damaged and ruptured surfaces, with short-term use lasting 24 hours or less.
- Short-Term Implantable: This material, referred to as "medical-grade," is based on hemolysis, genotoxicity, toxicity, and histopathological tests for muscle implantation, among others. Contact with the surface or implant exceeds 24 hours, with a maximum duration of up to 30 days.
- Long-Term Implantable: This medical silicone must undergo extended exposure testing, including carcinogenicity, chronic toxicity, and developmental toxicity, to ensure safety after long-term implantation in the human body.
medical silicone catheter
2. Industry Standards
Food-Grade Silicone: Food-grade silicone must comply with international food safety standards, ensuring that the material is non-toxic, odorless, tasteless, heat-resistant, and free of harmful substances such as BPA or BPS. In the United States, the FDA regulates food contact materials under Title 21, Section 177.2600 of the Code of Federal Regulations (CFR). The European Union has regulations (EC) No 1935/2004 and (EU) No 10/2011, which impose strict requirements on food contact materials, including leaching, migration, and toxicity testing.
Medical-Grade Silicone: Adheres to stringent regulations and standards to ensure biocompatibility and safety. Key standards include ISO 10993 and USP Class VI, covering acute toxicity, skin irritation, sensitization, hemolysis, cytotoxicity, and more, to evaluate the compatibility of silicone with living tissues. Note: ISO 10993 is a series of standards providing guidelines for the biological evaluation of medical devices, including biocompatibility testing protocols. USP Class VI is a standard for assessing the biocompatibility of materials used in medical devices and implants.
3. Material Purity
Food-Grade Silicone: Uses non-toxic silica as the main component and remains stable within a temperature range of -50°C to 250°C. Although it has high purity, it may contain trace impurities that are within permissible limits and pose no health risk.
food grade silicone material
Medical-Grade Silicone: Has higher purity with almost no impurities. To ensure safety in medical applications, medical-grade silicone is often produced in clean rooms and undergoes special processing techniques to minimize impurities and contamination.
medical grade silicone material
4. Application Fields
Food-Grade Silicone: Due to its resistance to extreme temperatures and non-toxicity, it is widely used in the food industry. Common applications include ice cube trays, baking molds, kitchen utensils, food containers, gaskets for food processing equipment, and oven seals.
silicone kitchenware
Medical-Grade Silicone: Due to its high purity and biocompatibility, it is extensively used in the medical and healthcare fields. Typical applications include baby products (such as pacifiers and bottles), surgical implants (such as artificial joints and breast implants), medical catheters (such as urinary and infusion tubes), menstrual cups, seals and gaskets for medical devices, scar treatment silicone sheets, and respiratory masks.
silicone breast implants
5. Price Differences
The cost of food-grade silicone is relatively lower, whereas the production cost of medical-grade silicone is higher. This is primarily because medical-grade silicone must be produced under more stringent conditions to ensure safety and performance in the most demanding environments.
Conclusion
Both food-grade silicone and medical-grade silicone are safe and reliable materials, but they differ significantly in terms of applications and standards. Food-grade silicone primarily focuses on non-toxicity and resistance to high and low temperatures, while medical-grade silicone places greater emphasis on biocompatibility and stability. When choosing silicone products, users should select the appropriate grade of material based on their specific needs.
