Biological assessment for medical devices (ISO 10993)
In company Opleiding
A total of 20 different parts of standards are encompassed in the ISO 10993 that addresses the determination of the effects of a medical devise on tissue for a complete biological safety evaluation. The range of biological hazards is wide and complex. In designing medical devices the choice of the best material(s) with respect to its tissue interaction needs to be considered and its biocompatibility assessed prior use in humans. Biological testing is based upon in vitro and in and ex vivo testing so that the anticipated behavior when a device is used in humans can be adjudged, but with precautions.
A solid risk assessment is part of the product design (ISO 14971) and outlines the possible hazards of tissue/device interaction that requires a biological evaluation. Application of the ISO 10993 is essential as part of the pre-clinical assessment of the product’s safety and performance evaluation, and the test results are to be used in the technical dossier to apply for CE mark.
The correct categorization of medical devices is essential to determine the level and type of required biological testing. The general categorization of devices is based on the nature and duration of their contact with the body. The evaluation of existing relevant data limits the need for additional safety testing, but if needed, additional tests are to be planned, developed and implemented to address the irritation, toxicity, sterilization, degradation and/or physico-chemical characterization of materials that come into contact with the human body.
In company opleiding (datum in onderling overleg).
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Erkenningsnummer Allanta: DV.O105117
In-company training or consulting (in case of a specific problem) with in-depth insights in the following possible topics:
- The product development cycle
- The Medical Device Directive, essential requirements and conformity assessment
- Fundamentals of risk management (ISO 14971)
- Classification of devices to determine required tests
- Literature review procedure
- Evaluation, testing and sample preparation (Part 1, 12)
- Animal welfare requirements (Part 2)
- Toxicity testing: genotoxicity, carcinogenicity, cytotoxicity, immunotoxicity and systemic toxicity (Parts 3, 5, 10, 11 and 20)
- Product implantation: tests for local effects (Part 6)
- Tests for interactions with blood (Part 4)
- Ethylene oxide sterilization : watch out! (Part 7)
- Degradation of and leachables from your product (Parts 9, 13, 14, 15, 16, 17)
- Product characterization (Parts 18, 19)
- Compilation of test results to compose the Technical Dossier
All students who attend 75% of classes, will receive a certificate of participation.