Safety of Medical Electrical Equipment - IEC 60601-1 (Edition 3.2) Basic Course

Instructor-led Training1 DayBeginnerVirtual Classroom

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 practice-oriented knowledge of the IEC 60601-1:2005+A1:2012+A2:2020 standard (Edition 3.2).
  • Active Medical Device Manufacturers
  • Employee Development Departments
  • Employee 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 security, and essential features
    • Supplementary Standards, Part 2 Standards, Overview of Standards
    • Structure of IEC 60601-1
    • Writings, abbreviations, definitions
    • Medical Electrical Device, Accessories, Medical Electrical System
    • Scope of application, foreseeable misuse, service life, components
    • Purpose of the standard
    • Risk management
  • First Defects, Multiple Faults, Safety Concepts
  • Fundamentals of tests according to IEC 60601-1
  • Classification, Application Parts, Protection Classes
  • Accompanying documents

The safety of medical electrical equipment is regulated by 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 produce safe medical electrical devices, the normative requirements for the development process of the medical device must be met. 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.

Price (excl. TAX)
from$ 950.00

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Book Now: Safety of Medical Electrical Equipment - IEC 60601-1 (Edition 3.2) Basic Course
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From 16.Oct.2024
$ 950.00 excl. TAX

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Price (excl. TAX):
$ 950.00

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