Molded Rubber Products Used in the Medical Industry

Posted by Jack Scarlett on June 1st, 2021

Given the essential role provided by the medical industry, the various devices and products commonly used by doctors and health professionals need to be able to function properly at all times. From surgical devices to laboratory testing to the storage of pharmaceutical products and everything in between, the medical grade materials created by molded rubber products manufacturers are a necessity in the accomplishment of many day-to-day tasks.

Custom Molded Rubber Parts for the Medical Industry

The medical industry, of course, involves much more than what you see during a typical trip to a hospital or doctor’s office. Countless other processes are involved in keeping people safe and healthy, many of which require the use of a durable, flexible material that can withstand repeated chemical and physical interactions. It’s for this reason that synthetic materials like silicone and rubber are often selected to assist with medical processes.

Medical Uses

All material scientists and rubber molded parts manufacturers know that the physical and chemical properties of these products make them ideal for a variety of uses. When it comes to medical procedures, it's common to see engineered rubber parts on surgical devices, mechanisms of drug delivery, and diagnostic machinery.

However, medical-grade rubber isn’t just used for patient-facing procedures. Outside of direct patient interaction, there are countless laboratory devices, pharmaceutical packaging products, and highly-sterilized surface coverings that benefit from the use of custom molded rubber parts.

Ensuring Medical-Grade Quality

As is the case with all materials, tools, and devices with wide-spread use in the medical industry, there is a meticulous testing and quality assurance process to ensure that rubber products are functioning properly. Manufacturers of rubber products for use in hospitals and labs are required to test their products for biocompatibility, ensuring that the product will not lead to health complications or adverse reactions in human patients. This process involves toxicological testing and assessment of the human immune response and is tested under two guidelines.

ISO 10993

An internationally-used standard, ISO 10993 divides medical devices into different categories and sub-categories depending on where the product will be interacting with human patients and for how long. Different classifications housed within this standard determine things like the biological safety of devices and whether they may infiltrate the body.

USP Class VI

A testing requirement that informs the FDA’s decision-making process within the United States, the USP Class VI is another resource that helps identify the effects of patient exposure to plastic and rubber medical products.

By ensuring that rubber products are medical-grade and safe for human use, the ISO 10993 and USP Class VI validation and verification processes provide an invaluable resource for businesses.

If you’re searching for molded rubber products manufacturers to ensure optimal performance from your medical devices, contact custom rubber parts manufacturer today to learn more about how our solutions are right for you!