Do you need medical grade silicone for products like medical tubing or the seals on diagnostic equipment? Then you’ll need to know what qualifies as a “medical grade silicone” and which regulations and standards apply. You may need more than an FDA approved silicone, but that depends on the application and the locations or jurisdictions where the silicone will be used.
Keep reading to learn more and ask Elasto Proxy for medical grade silicone.
Medical Grade Silicones and Biocompatibility
Medical grade silicone is formulated and tested for use in medical and healthcare environments. Unlike the general-purpose silicones that are used in many consumer and industrial products, medical grade silicones are biocompatible. That means they’re safe for use with the human body and don’t pose a serious risk of injury or toxicity.
There are three main types of medical grade silicones.
- Non-implantable silicone is safe for short-term contact with human skin or tissue.
- Implantable silicone is designed for prolonged or permanent implantation in the body.
- Restricted grade silicone is used in healthcare applications but is not implantable or designed for use in life-supporting devices.
Elasto Proxy offers non-implantable and restricted grade silicones. We source these materials from a global network of trusted suppliers and can provide you with either ready-to-fabricate materials or ready-to-install products. We do not provide implantable silicones for medical devices.
FDA Regulations and Medical Grade Silicone
In the United States, the Food and Drug Administration (FDA) maintains a section of the code of federal regulations (CFR) known as FDA CFR Part 177.2600. This section applies to food contact substances instead of medical materials, but it does provide a foundation for material selection in the medical and pharmaceutical industries.
Today, many silicone suppliers market their products as either FDA approved or FDA compliant. This means that the material is made of ingredients that are listed in CFR 21, Part 177.2600. As such, these silicones will not release harmful substances under normal conditions of use. Whether a material is FDA approved or FDA compliant depends on the level of testing and who performed it.
If you’re designing a medical device, remember that you’ll need the FDA to evaluate the entire product. This includes materials of construction for components like silicone seals. In other words, selecting constituent materials that are FDA approved won’t ensure that the full medical device receives FDA clearance. In addition, USP Class VI or ISO 10993 may apply to your design.
USP Class VI Silicones
USP Class VI silicones are biocompatible elastomers that have low levels of extractables, chemicals that can migrate from a material at elevated temperatures or with surface exposure (such as contact with human skin). The United States Pharmacopeia (USP), an independent, nonprofit organization, formulates these standards, which inform decision-making at the FDA.
USP Class VI requirements are stricter than those in the other numbered classes that the USP defines. However, items made from USP Class VI silicones cannot be implanted within the human body for longer than 29 days. Consequently, applications involve short-term or intermittent contact with skin or living tissue. Examples include medical tubing and pharmaceutical seals and gaskets.
If your application requires USP Class VI silicones, it’s important to understand the difference between certified and compliant materials. Certified USP Class VI silicones have have been independently tested for system toxicity, intracutaneous reactivity, and implantation. Compliant materials may pass these same tests, but they lack independent testing verification.
ISO 10993 Silicones
ISO 10993 silicones meet stricter biocompatibility requirements than USP Class VI silicones. ISO 10993 uses different testing protocols, and the time of exposure can be limited, prolonged, or permanent. Before choosing an ISO 10993 silicone, determine which protocol applies. For example, ISO 10993-17 measures the level of a leachable substance.
Fundamentally, ISO 10993 is more than a framework for identifying medical grade silicones. This international standard provides a way to identify and quantity a material’s chemical ingredients. ISO 10993 silicones typically cost more than other medical grade silicones, so it’s important to determine what you really need during material selection.
European and Canadian Standards
If your company plans to sell its products within the European Union (EU), then EU MDR 2017/745 and REACH may apply. Medical silicones that comply with the EU’s Medical Device Regulation (MDR) are eligible to receive a CE mark, a designation that’s earned after a thorough risk assessment and demonstrations of clinical and safety performance. REACH governs chemical safety.
Canada has standards for medical grade silicones, but they are not standalone Canadian-specific requirements. Instead, Health Canada recognizes and enforces international standards such as ISO 10993 for medical devices. USP Class VI is not a formal regulatory requirement in Canada, but companies that sell in both the U.S. and Canada may follow it.
Ask Elasto Proxy for Medical Grade Silicone
Elasto Proxy distributes and fabricates FDA approved silicones, including materials that meet USP Class VI, ISO 10993, or other requirements. If you’re ready to discuss your medical application, talk to our team. We are ISO 9001:2015 certified and have facilities in Canada, the United States, and Europe.
