Biocompatibility… a vast topic with numerous applications, but still a headache for medical device manufacturers!
What tests should be performed? In what order? The 2018 version of the ISO 10993-1 standard on the biological evaluation of medical devices as part of a risk management process provides answers to these questions…
- The first step is to conduct a biological risk analysis (taking into account the parts that come into contact with the patient or even the user) as part of the risk management process (ISO 14971:2019). A risk-based approach will enable you to properly define the strategy to be adopted to best mitigate the biological risks associated with the use of the device, using a consistent and justifiable approach.
- Next, you will need to prepare a biological risk assessment report. The purpose of this report is to document your biological risk management strategy and to present, with supporting evidence, all the data that enables you to control the identified risks.
The first part of this report is the chemical characterization, which must be performed on the finished product. It may be based on the literature and/or laboratory spectrometric tests. The strategy adopted for this chemical characterization is based on the risk associated with the device and, therefore, on the risk analysis conducted beforehand.
The purpose of the evaluation report is to collect and thoroughly analyze all existing data on the device, the materials it is made of, and the components that come into contact with it during manufacturing (additives, degreasers, residues, cleaning agents, etc.). This data may include bibliographic information, material data, supplier technical data sheets, etc. Simple material certificates are no longer sufficient!
Notified bodies have significantly raised their standards in recent years regarding biological risk control. The process has become lengthy and complex, and the associated budget has increased accordingly… A biological risk control strategy is an area that requires support from experts (consultants, laboratories).
We can help you with this process. Please don’t hesitate to contact us.