ISO 10993-18 CHEMICAL CHARACTERIZATION

In ISO 10993, medical device extracts/dissolvable evaluation and research occupy an important step in product development.
The composition of medical device materials requires a step-by-step chemical test step to analyze the possible biological hazardous substances. ISO 10993-18 is a method for the analysis of medical device material composition and a part of the risk analysis of medical materials. The analyzed substances are identified and analyzed for content as the basis for medical device suppliers to evaluate the biological compatibility.

ISO 10993-18 test purpose:

Identify the structural composition of the medical device material.
By identifying the chemical composition of the material and the quantification of the characteristics of the material.
Whether any chemical substances migrate into the medical device during the manufacturing process (release agent, sterilization residue, process impurities).
The chemical substances of the extracts are studied under the extraction conditions of the laboratory under simulated clinical use.

The chemical substance of the dissolution is studied under simulated clinical use. Which medical device product needs to be tested for dissolution and extraction?

According to the US FDA's public recommendation in 2020 for the chemical evaluation of medical device against ISO 10993-01, the following conditions require chemical testing of medical materials:
Innovative materials, medical device materials that have never been marketed in the United States.
Some surfactants, plasticizers, and antioxidants are used to improve the manufacturing process's material properties and medical materials.
It is known that the use of a certain toxic chemical substance combination drug or a biological preparation medical material combination product requires a chemical evaluation of the material and an evaluation of the toxicity of the gene and tumor.
Some medical materials can be expected to change properties over time, such as composite materials or degradable materials.
In the biocompatibility test, there are some unexpected results, and it may be necessary to do more chemical tests of materials together for evaluation.
Although some medical device materials have been used for a long time (such as infusion cannula), there is not enough information to understand the toxicity of the additives in the manufacturing process and the medical materials, and the chemical evaluation of the medical device is required.