What is the Difference Between Food Grade and Medical Grade Silicone?

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The main difference between food grade and medical grade silicone lies in their intended applications and the strictness of their standards. Here are the key differences:

Food Grade Silicone:

  • Safe for use with food, such as food storage or cooking utensils.
  • Typically found in products like silicone molds, baking mats, and baby products.

Medical Grade Silicone:

  • Safe for use in applications that touch human skin or are in contact with other human tissue.
  • Tested for biocompatibility, meaning it is designed for safe use inside the body.
  • Meets USP standards and approval from ISO and FDA.
  • Has a good history of successful testing of implantation on animals and humans.
  • Stricter standards in terms of manufacturing process and quality control.
  • Used in applications like implants, catheters, syringe pistons, menstrual cups, and more.

While both food grade and medical grade silicone are non-toxic, temperature-resistant, and inert, medical grade silicone is held to a higher standard due to its more sensitive applications. It is essential to choose the appropriate type of silicone for each specific application to avoid harm and ensure safety.

Comparative Table: Food Grade vs Medical Grade Silicone

The main differences between food-grade and medical-grade silicone are their intended uses, durability, and the standards they must meet. Here is a table comparing the two:

Property Food-Grade Silicone Medical-Grade Silicone
Intended Use Safe for contact with food, such as storage and cooking Safe for applications that touch human skin or are in contact with human tissue
Durability Generally less durable, may shrink or become brittle over time More durable, with greater temperature and chemical resistance
Standards Meets food safety regulations, such as FDA, BfR, and EU regulations Meets medical safety regulations, including USP standards, ISO, and FDA approval
Applications Examples include baking molds, ice cube trays, kitchen utensils, food containers, and gaskets for food processing machines Examples include long-term implantable devices, medical-healthcare grade silicone, and class VI silicone tested for biocompatibility
Curing Systems Platinum-catalyzed curing systems are recommended for both food-grade and medical-grade silicones Platinum-catalyzed curing systems are recommended for both food-grade and medical-grade silicones

Both food-grade and medical-grade silicones are non-toxic, odorless, and inert, making them safe for their respective applications. However, medical-grade silicones must meet stricter standards due to their more sensitive applications, such as contact with human tissue.