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Chemical laboratory services, chemical characterization according to DIN EN ISO 10993-18

DIN EN ISO 10993-18 Chemical characterized is a prerequisite for biocompatibility evaluations of medical devices. It aims to identify potential hazards and assess compliance with limits for biocompatibility. This assessment is carried out to determine whether the chemical composition of a medical device is suitable for use. This test includes the identification and characterization of the chemical constituents of materials, auxiliary materials, operating and packaging materials. In addition, this process can help to screen new substances for potential biocompatibility.

The ISO 10993 series covers chemical substances released by medical devices. This standard describes the characterization of degradation products, the determination of safety limits, and other aspects of degradation assessment. It is intended for materials suppliers and manufacturers of medical devices. It is based on the latest information about biocompatibility. The ISO 14993-18 is also a reference tool for the industry.

Typical procedures used in chemical characterization include the following: batch-to-batch verification, cleaning fluid analysis, counterfeit medicine analysis, in-use simulation studies, and in-process assessment. The FDA's approval criteria require complete qualitative descriptions of a medical device, its additives, and processing residues. It also requires the identification of the supplier, lot, and batch of materials. These tests are necessary to ensure that the medical devices are safe for use.

DIN EN ISO 10993-18: Chemical characterization is the first step in assessing the biological safety of a material. It is also a crucial step in judging the equivalence of a raw material with a clinically proven material. It is essential to determine the risks and benefits of any material and its component parts before they are used in a medical device. It is also imperative to note that DIN EN ISO 10993-18 does not specify how to analyze or identify the chemical composition of a material.

To ensure the safety of the medical device, the chemical characterization should reflect the nature of the exposure and duration of use. It should be performed to determine whether a material is safe for the use. To ensure the safety of a medical device, the data obtained from the chemical characterization should be accurate and reliable. The results of this test should also be used for further development and manufacturing. In addition, it should also include any other relevant data.

To assess the risk of a medical device, the chemical characterization of the device is essential. The standards are required by law to prevent the presence of hazardous substances in a medical device. This standard is applicable to the manufacturing, distribution, and disposal of a material in the environment. The DIN EN ISO 10993-18 standard is also relevant to the testing of medical devices. The testing performed for these devices should be conducted in a laboratory.