The “ability of a medical device or material to perform with an appropriate host response in a specific application” (ISO 10993-1:2018).
Throughout the design and development of medical devices and products it is important for engineers, microbiologists, and chemists to ensure that products elicit little to no biological responses. Biocompatibility is also a term referred to in the field of medicine to define the suitability of a medical device for patient and physician use.
Using ISO 10993-1:2018 through 10993-23:2021, which range from quantification of degradation product (part 9) to tests for irritation (part 23), medical devices undergo biological evaluation to ensure they are safe to use in patients. The beginning of this standard collection (ISO10993-1:2018) includes Table A.1, which classifies required testing for medical devices based on patient contact time and level of patient contact. Furthermore, the use of ISO 18562, ISO 18562-1:2017 through ISO 18562-4:2017, classifies the leachable products of these medical devices.
In medicine, pacemakers are one example of a medical device that is implanted for extended periods of time (>30 days). Their biocompatibility is particularly relevant to ensure this device does not cause any post-operative infections, while also avoiding degradation in response to the macrophages naturally occurring form the human immune system. Otherwise, degradation could cause inflammation, and resultantly complications for the user. Avoiding both infection and inflammatory responses are the primary goals of thorough biocompatibility testing.
Using a variety of different tests (including leachable testing), which are elaborated upon in ISO 18562 (ISO 18562-1:2017 through ISO 18562-4:2017) and ISO 10993 (ISO 10993-1:2018 through ISO 10993-23:2021), one can determine the required testing and resulting safety of a medical device. Inherently, devices that are not in contact with a patient for an extended period or medical devices that do not enter the body at any point do not require the same testing as those that are permanently implanted (as outlined by Table A.1). MicroBio Consulting identifies exactly what testing your medical devices require before going to market.
Using ISO 18562 and ISO 10993 MicroBio tests the leachable products and safety of your medical devices, respectively. In ISO 18562 leachable studies, which are oftentimes in vitro, mimic the temperature, time, and solvent nature of being exposed to human tissues and blood. Meanwhile, ISO 10993 is used to ensure the safe sensitization, irritation, toxicity, and chemical characterization of a medical device as is reflected using biocompatibility evaluations completed by MicroBio Consulting. These evaluations are a tool used by MicroBio consultants to help you and your medical device or product.
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1. ISO 18562
2. ISO 10993