Material selection and risk analysis before the production of surgical saw blades is the most important part of the design process for medical devices. When proving biological safety requirements, it must be shown to be biocompatible in line with EN ISO 10993-1:2020, Biological evaluation of medical devices – Part 1: “Evaluation and testing in a risk management process” standard when sufficient data is not available.
Biocompatibility assessment is a mandatory practice in order to protect against potential biological risks arising from the use of surgical saw blades. These studies are carried out to reveal the potential of the product to physically damage the biological functioning of the body with chemicals that interact biologically with the body by superficial contact of the surgical saw blade.
Chemical characterization tests aim to determine the amount of chemicals extracted from surgical saw blades by measuring them with analytical devices and to assess exposure levels and toxicological risks.
Many methods are used in chemical characterization tests, including the following methods
The chemical characterization processes of surgical saw blades are; identification of materials, characterization of materials through qualitative and quantitative chemical composition, auxiliary substances used in production, process pollutants, sterilization residues, estimation of the possibility of release of chemical substances from medical devices or production materials under clinical use conditions, determination of chemical substances released by medical devices under clinical use conditions.
All these processes are documented with a biological assessment plan and the declared tests are performed in an accredited laboratory. Test results are evaluated by competent persons and a Biological Assessment report is created.
With the MDR transition, the accuracy and timeliness of product safety evidence for surgical saw blades, like all medical devices, has gained importance. The toxicology report is a mandatory report in the product safety section of the MDR technical dossier in the biological compliance area. We recommend that you make sure that you have this report in your files, and if so, that it is up to date, prior to the Technical File audit.
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