Safety of Medical Electrical Equipment - IEC 60601-1 (Edition 3.2) Basic Course
At the end of this training, you will:
- Know the requirements for the development process of medical devices.
- Ensure the safety of your electrical medical devices.
- Acquire practical knowledge 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].
- Manufacturers of active medical devices
- Employees of development departments
- Employees of regulatory affairs
- Employees of testing laboratories, notified bodies, standardization organizations, and authorities
- Introduction to the requirements of the standard and international approvals
- Introduction to IEC 60601-1:2020, Edition 3.2
- Security, basic safety, and essential performance
- Supplementary Standards, Part 2 Standards, Overview of Standards
- Structure of IEC 60601-1
- Documents, abbreviations, and definitions
- Medical Electrical equipment, accessories, medical electrical system
- Scope of application, foreseeable misuse, service life, components
- Purpose of the standard
- Risk management
- Initial faults, Multiple faults, Safety concepts
- Basic principles of testing in accordance to IEC 60601-1
- Classification, Applied parts, Protection classes
- Accompanying documents
The safety of medical electrical devices is regulated in the international standard IEC 60601-1 (Edition 3.2). The requirements of the standard must be taken into account in the development process of medical devices. In order to manufacture safe medical electrical devices, the normative requirements for the development process of the medical device must be complied with. Our one-day basic course explains the structure of the standard. It explains the safety philosophy and introduces you to the basics of the tests prescribed in the standard.
- Reliably design and test medical devices.
- 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.
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.
Participants will receive a Certificate of attendance from the TÜV SÜD Academy.