Safety & EMC Requirements for Medical Devices based on IEC 60601
 | Top-selling course |
IEC 60601-1 & 2 is a standard that applies to the basic safety and the essential features of Medical Electrical Equipment and Medical Electrical Systems. As IEC 60601-1 & 2 becomes widely accepted across the globe, undergoing the training will help you minimize risk with redesign development right from the beginning.
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?
Quality Assurance and Regulatory Affairs professionals, R&D engineers, auditors within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in Medical Electrical equipment and Medical Safety Testing.
Course Agenda
The Safety of Medical Electrical Equipment – IEC 60601-1 & 2 Training program shall cover the following modules:
- Scope, purpose, and related standards
- Scope of Changes
- Normative references
- Standards and Classifications
- Common Medical Electrical Safety Tests
- General requirements for Testing Medical Electrical equipment
- Classification of Medical Electrical devices of ME systems
- Marking, entries and documents of ME equipment
- EMC Requirements
Course Description
This topic will enable participants to understand how safe electrical medical device can be manufactured, along with common methods for risk assessment and integration of ISO 14961 principles. This is also helpful in identifying specific requirements and classification of medical electrical equipment. The course also helps participants with the following:
- Become confident in how to develop a safe electrical medical device that meets type approval requirements
- Demonstrate compliance to standard requirement
- Have a structured approach while implementation
- Ensure product development with desired quality and safety standards
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 be assessed through an online examination (open book) at the end of the course. Minimum passing% criteria: 60%.
Participants who score 60% and above in the online examination will be issued a TÜV SÜD America's Course Completion certificate. Unsuccessful candidates will be issued a certificate of attendance.
Prerequisites
Delegates will benefit from reviewing the IEC 60601-1 and IEC 60601-2 standard before attending this course.