Safety of Medical Electrical Equipment - IEC 60601-1 (Edition 3.2) Advanced Course
Reliably Controlling Electricity in Medical Devices – Design and Testing Requirements
At the end of this training, participants will:
- Be familiar with the requirements of the medical device development process.
- Ensure the safety of your electrical medical devices.
- Acquire the know-how for the practice-oriented implementation of the IEC 60601-1:2005+A1:2012+ A2:2020 standard (Edition 3.2).
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
Who Should Attend?
- Active Medical Device Manufacturers
- Employees of testing laboratories, notified bodies, standardization organizations and authorities
- Employees of development departments
- Employees in the Regulatory Affairs department
Course Agenda
- Limitation of voltage, current or energy
- Voltage Limiting/Energy Limitation
- Protective
- Leakage currents and their measurement (testing)
- Structure of medical devices
- Power Supplies, Intermediate Circuits, Application Parts
- Interfaces, Housings
- Normal State and First Failure
- Insulation barriers
- Isolation diagram
- Types of insulation, protective measures
- Specifying Operating Voltages
- Dielectric strength and its values
- Determination of creepage and clearance distances for patients and operators
- Development of an isolation diagram
Course Description
The safety of electrical medical equipment is regulated by the international standard IEC 60601-1 (Edition 3.2). Your requirements must be taken into account in the development of medical devices. The seminar builds on the basic course and deepens your knowledge of the testing requirements. The focus is on the general requirements for electrical safety, the specifications for leakage current tests and insulation coordination.
Benefits
- The seminar deals with internationally valid standards and is also suitable for implementation abroad.
- The contents of the seminar correspond to the current status of revision/harmonization.
Methodology
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Learning Assessments
Participants will receive a Certificate of attendance from the TÜV SÜD Academy.
Prerequisites
Safety of Medical Electrical Equipment - IEC 60601-1 (Edition 3.2) Basic Course