MedicalMountains GmbH Chemical characterization as a basis for biocompatibility assessment

target group

Employees from the areas of quality assurance/quality management, product management, regulatory affairs and management.

content

Since autumn 2018, with the amendment to DIN EN ISO 10993-1, chemical characterization has been at the beginning of the assessment of the biocompatibility of a medical device. The selection of the analyzes should be based on a risk analysis of the materials and processing aids used. Based on these analysis results, a qualitative and quantitative evaluation of the detected substances is carried out. The seminar is intended to convey basic chemical principles that are necessary for the risk assessment of the processing aids, but can also be used to check the necessary analyzes for completeness. All aspects to be considered on the way to an evaluation are also addressed; the extraction according to ISO 10993-12, an overview of ISO 10993-18 and the evaluation according to ISO 10993-17.

topic overview

• Introduction to organic and inorganic chemistry
• Introduction to chemical analysis methods - overview DIN EN ISO 10993-18
• View materials/processing aids to select an analysis
• Process of chemical characterization - meaning of DIN EN ISO 10993-12
• Qualitative and quantitative assessment according to DIN EN ISO 10993-17
• Outlook for further biological tests - DIN EN ISO 10993-5f

previous knowledge

Knowledge of the basic requirements for medical devices is helpful.

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