What is the difference between medical silicone and food grade silicone technology?

liquid silicone rubber injection molding process
Medical silicone and food grade silicone differ in material properties, production processes, and application fields. The following are some key differences:
Material standards:
Medical silicone: produced according to strict standards in the medical industry, it needs to meet requirements such as biocompatibility and non toxicity, and often passes biocompatibility tests such as ISO 10993.
Food grade silicone: Products used in contact with food must comply with food safety regulations and standards, such as CFR Title 21 of the US FDA or EU Regulation No. 10/2011 of the European Union.
Raw material purity:
Medical silicone typically requires higher raw material purity to ensure its safety and reliability.
Although food grade silicone also requires high purity, it may not be as strict as medical grade in certain performance indicators.
Production process:
In the production process, both may use liquid injection molding (LSR), compression molding, or other processes. However, due to different uses, there may be differences in specific process parameters such as vulcanization temperature, time, etc.
Product type:
Medical silicone is commonly used in the manufacturing of medical device components, implants, and other products that require high cleanliness and stability.
Food grade silicone is commonly used in kitchenware, cooking tools, or products that come into direct contact with food.
Quality Control:
For medical grade silicone rubber products, quality control during the production process is stricter, including strict control of microbial contamination and requirements for sterile packaging.
For food grade silicone rubber products, strict hygiene conditions are also required during the production process to avoid contamination
Certification and Compliance:
Different countries and regions have different regulatory requirements for these two types of silicone rubber. Manufacturers need to obtain corresponding certifications and approvals based on the target market.
Difference in use environment: Due to different application scenarios, there may be specific demand differences in durability and anti-aging capability.
Due to the improvement of quality and safety standards, the use of higher grade materials may lead to increased costs
Understanding these differences helps in selecting suitable materials and developing appropriate processing techniques. If you are engaged in related research or development work, please choose the correct materials and technology path according to your specific needs, and always follow relevant industry standards for operation.
Different application fields: Medical silicone is mainly used in the medical field, such as artificial heart valves, meninges, breasts, joints and other medical implants, as well as medical catheters. Food grade silicone is mainly used in food related fields, such as food molds, pacifiers, kitchenware, household appliance sealing strips, etc.
Quality requirements: Due to the higher direct contact rate between medical silicone and the human body, the quality requirements are stricter. Medical silicone not only needs to comply with FDA certification standards, but also needs to be tested for biocompatibility and other aspects. Food grade silicone mainly requires food related certification.
There are significant differences in production process and performance requirements between medical silicone and food grade silicone. Understanding these differences helps us better understand the applications of these two materials in their respective fields and provides useful references for the development of related fields.