Every industry has its own buzzwords – terms that are used so often that sometimes the actual meanings get confused or lost. In the medical device field, one such buzzword is “medical-grade” material. This doesn’t mean that it’s wrong or should be ignored. Rather, it’s important to know what the true definition of this term means while developing your product.
Defining medical grade.
The notion of medical-grade can have different interpretations depending on whether you're examining it from a compatibility, regulatory, or risk management perspective.
In the United States, the FDA does not currently have a simple, hard-and-fast definition of medical-grade for materials. Instead, materials can be certified for biocompatibility through a range of tests and standards. At the same time, materials approved for medical devices must be used in a suitable manner and manufactured to certain standards in order for the final product to be approved for medical use.
While the process of getting a medical device approved and ready for market is complex, there are two important certification standards that you should look out for.
ISO:10993 for materials.
Materials that go into medical device products can be tested to ISO:10993 standards. Within 10993, there are 10 classifications for various products and uses (both internal and externally used). The standards tests for possible complications such as toxicity, degradation, and skin sensitivity.
For example, tapes and stick-to-skin adhesives that we source from our material suppliers are certified according to the following:
10993-5: Tests for Cytotoxicity—In Vitro Methods
10993-10: Tests for Irritation and Sensitization
By incorporating ISO 10993 approved materials, you can reduce risk and improve overall regulatory compliance for your medical device.
ISO 13485 for manufacturing.
In addition to using ISO 10993 materials, it's important that the facility manufacturing your product (or component) is also "medical grade." From this standpoint, you will want to work with a partner that is ISO 13485 certified. This means that the facility has exceeded quality and safety requirements for designing, producing, installing, and serving of medical devices.
How Tapecon helps.
When developing a medical device, it’s important to consider both materials and manufacturing to ensure quality, safety, and eventual regulatory approval. With more than 30 years of experience producing medical devices, Tapecon can take much of the guesswork out of making sure your components or product are considered “medical grade.”
First, we source ISO 10933 materials from industry-leading suppliers. Based on your specifications, we will test multiple materials options to determine the best options for your product. From there, we use our wide range of converting process to prototype and manufacture your product in our ISO 13485:2016 and FDA-registered facility. So you can be confident that the entire process it up the high demands of producing an approved medical device.