660-2025/01 – Output control testing (TVK)
| Gurantor department | Centre for Advanced Innovation Technologies | Credits | 4 |
| Subject guarantor | Ing. Vratislav Mareš | Subject version guarantor | Ing. Vratislav Mareš |
| Study level | undergraduate or graduate | Requirement | Compulsory |
| Year | 3 | Semester | summer |
| | Study language | Czech |
| Year of introduction | 2024/2025 | Year of cancellation | |
| Intended for the faculties | FMT | Intended for study types | Bachelor |
Subject aims expressed by acquired skills and competences
The subject of output control of medical devices is designed so that students gain an overview of how to effectively control and manage the output control of medical devices so that they meet certain standards and specifications. Medical device output inspection refers to the process of monitoring the output parameters of medical devices, which is necessary to ensure that medical devices are safe, effective and reliable for use in medical facilities. Furthermore, the aim of the course is to provide students with the knowledge and skills needed to perform type tests on medical devices, as well as to understand the regulatory framework related to type testing.
Teaching methods
Lectures
Seminars
Tutorials
Experimental work in labs
Summary
Students will become familiar with the principles of output control, regulatory requirements, measurement and testing techniques, quality control and problem solving. The course equips students with the necessary skills and knowledge for effective control of output control or performing a type test of medical devices. Students will learn about the regulatory requirements for type examination, the principles of type examination, the types of medical devices subject to type examination, the test and evaluation methods used in type examination, and the documentation and reporting requirements.
Compulsory literature:
Recommended literature:
[1] OGRODNIK, Peter J. Medical device design: innovation from concept to market. Academic Press, 2019.
[2] CHAN, Anthony YK. Biomedical device technology: principles and design. Charles C Thomas Publisher, 2023.
Way of continuous check of knowledge in the course of semester
Elaboration of measurement protocols
E-learning
Other requirements
No further student requirements are required
Prerequisities
Subject has no prerequisities.
Co-requisities
Subject has no co-requisities.
Subject syllabus:
1. Introduction to the output control of medical devices - definition and meaning, regulatory requirements, international standards and regulations
2. Requirements for technical documentation of final inspection and type tests – reports, protocols, requirements for documentation and reporting.
3. Measuring and testing techniques - calibration and verification, testing methods
4. Aspects of tests for output control. Practical examples
5. Methodologies for testing the output control of used materials
6. Type test - definition and meaning, regulatory requirements, safety testing
7. Test and evaluation methods used in type examination
8. Relationship of type examination and conformity assessment procedure - Module B: EC type examination, Module C: Conformity to type
9. Methods of testing and evaluating mechanical safety during final inspection
10. Verification of traceability – identification and marking of medical devices
11. Requirements for testing as part of regular safety inspections
12. New technologies and trends for retesting of output control/PBTK
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction
Předmět neobsahuje žádné hodnocení.