Content
Since 2018, with the amendment to DIN EN ISO 10993-1, chemical characterization has been the beginning of the assessment of the biocompatibility of a medical product. The selection of analyzes should be based on a risk analysis of the materials and process aids used. Based on these analysis results, a qualitative and quantitative assessment of the detected substances is carried out. The seminar aims to impart chemical basics that are necessary for risk assessment of process aids, but can also be used to check the necessary analyzes for completeness. All aspects that need to be taken into account on the way to an evaluation are also discussed; 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
- Consideration of materials/process aids to select an analysis
- Chemical characterization process – meaning of DIN EN ISO 10993-12
- Qualitative and quantitative assessment according to DIN EN ISO 10993-17
- Outlook for further biological experiments – DIN EN ISO 10993-5f
target group
Employees from the areas of quality assurance/quality management, product management, regulatory affairs and management.
Prior knowledge
Knowledge of the basic requirements for medical devices is helpful.
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
