Biocompatibility is a key property that needs to be complied with by most medical devices to fulfil medical regulations (e.g. EU MDR or US FDA regulatory requirements). Final medical devices must be tested according to ISO 10993 and it is the responsibility of the Medical OEM manufacturer to make sure that such tests are conducted and passed. Biocompatibility tests are expensive and there is the risk that the required medical device may not pass one or more of them. The implementation of specific production procedures like GMPs (Good Manufacturing Practices), clean rooms etc. is critical, but positive test results cannot be assured without the correct pre-selection of all materials needed to produce each component of the device.

ABS plastics are widely used materials in external enclosures applications of medical devices. In this article we will discuss the different ABS material options available in the market to cover the biocompatibility needs of medical devices, and the risks associated with each one of them.

A first distinction is between what ABS manufacturers call “medical ABS grade”, “food contact grade”, “healthcare grade” or “biocompatible grade”. These definitions are very different and refer to different concepts. A medical grade includes a set of services and material properties that have been developed for medical device applications, but the term itself does not specify exactly what is really included or not. It is important to go through the complete regulatory compliance list and the set of services included, like for example the duration of the no-change agreement, notification periods, or the extended sample storage availability. Such services are specific to guarantee the long-term supply and quality support to the medical device industry and are normally not available for a general ABS portfolio.