On your first question, the major difference in this new edition of ISO 10993-1 is the incorporation of a risk management process as part of the overall biological evaluation and development of each device. This approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, thus enabling a full evaluation to be made of the biological responses to each medical device that are relevant to its safety in use.

On your second question, the justification for not performing biocompatibility testing would involve a rationale that compares the device or materials with similar products that are already on the market and have undergone favorable biocompatibility testing or involve favorable historical use data. However, the processing of the materials into the final device and the interactions of the materials with other materials in the device would have to be addressed as well.

Material characterization is addressed in the ISO standards and can be performed at different levels. As indicated in ISO 10993-1, “The extent of chemical characterization required depends on what pre-clinical and clinical safety and toxicological data exist, and on the nature of the body contact with the medical devices.” It also states, “If the combination of all materials, chemicals and processes has an established history of safe use in the intended application, then further characterization and biological evaluation might not be necessary.”

Figure 1 in the ISO 10993-1 guidelines gives a summary of the systematic approach to a biological evaluation of medical devices as part of a risk management process. It includes steps such as obtaining device material identification and chemical characterization (ISO 10993-18), comparing the material with a known commercially available device, comparing the chemical composition with the known commercially approved device, etc.

For devices that have the same or very similar materials compared with known materials with favorable biocompatibility results, the material characterization testing can be performed using chemistry tests that look for nonvolatiles, volatiles, or semivolatiles using mass spectrophotometry (ICP-MS). This testing can be done for the new materials for approximately $2000 to $3,000, and the turnaround time is approximately 14 to 17 days. ICP-MS testing can also be conducted for test articles with metals.