Are Your Finishing Systems Upholding Biocompatibility Standards?
Biocompatibility might sound like something you’d hear about in an Environment 101 course, but when it comes to biocompatibility standards for manufactured, finished products, it’s very much a relevant topic. In layman’s terms, a product that is biocompatible is one that doesn’t cause a response in living organisms. When that product comes in contact with humans, things like allergic reactions and complications (both short-term and long-term) don’t occur. The product is made with materials that aren’t toxic, and are friendly to the human body.
The extent to which a product is biocompatible is often determined by looking at three core components: its chemical and physical nature, what it will be exposed to (often, what type of human tissue) and the duration of human exposure. Biocompatibility requirements are listed within the ISO Standard 10993, Biological Evaluation of Medical Devices.
Biocompatibility standards matter because as a company, you want to make sure that your products are safe for all who interact with them, including manufacturers and consumers. Toxic materials and coatings that cause any type of unexpected, adverse reaction can leave your company vulnerable to a host of liabilities. Biocompatibility is especially critical when finishing systems interact with parts that will be used for biomedical components – either in contact with or placed inside of the human body.
When working with a finishing system, you’ll want to ensure that the final surface or coating they provide your product is truly biocompatible. This means that the media used to finish your product (the media that came in direct contact with the product’s surface) should be biocompatible. There are many different types of media that can be used with different types of finishing systems, from the most natural of elements like Corn Cob Grit and Walnut Shell Grit, to more synthetic substances like melamine plastic grit. Note that just because a substance is synthetic, it doesn’t mean it can’t pass a biocompatibility standard. Many synthetic materials are safe for interaction with humans; it’s all about ensuring they fall into an approved substance category.
In addition to the type of media used to finish a product, the environment surrounding the finishing system should also be considered. Are there potentially hazardous materials or substances in the general vicinity, or those that have previously been encountered by an operator? Biocompatibility requirements should a part of workplace training for all employees, so that everyone in the surrounding working area is familiar with what can and cannot pass for acceptable exposure.
In addition to the safety of the materials and substances a product interacts with, biocompatibility standards also address the physical make of the product as well. For example, for many products to be biocompatible, especially those used for medical purposes, surfaces need a very specific type of finish, sometimes known as micro-finishing. These medical products need to have surfaces that won’t allow bacteria to live or grow; they need corrosion-resistant surfaces and particularly smooth surfaces. For this reason, it’s highly important that you work with a finishing system that can provide precise, measurable results.
Ultimately, there’s an intense level of precision and consistency that’s required for finishing systems to meet biocompatibility standards. That’s why choosing a finishing provider that has years of experience in the industry is key. Turn to Kramer Industries for your next project to have an expert on your side.