Course Description

IEC 60601-1 Ed 3.1 - Medical Electrical Systems and Protection Against Mechanical Hazards

Course Description:

This three-part course starts with a comprehensive review of the definitions related to medical electrical systems and the basic requirements for these systems. The second part examines the mechanical hazards of medical electrical systems, focusing on the changes implemented in Edition 3.1. The final part of this course explores the testing involved in determining the adequacy of mechanical strength with resistance to heat.

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Identify the particular requirements and classifications of medical electrical equipment
  • Apply the requirements with regards to applicable mechanical testing methods
  • Understand the changes in mechanical testing with regard to Edition 3.1 and update existing devices

Who Should Enroll:

Validation, R&D, and quality assurance engineers and notified body auditors are all encouraged to participate in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • EC 60601-1 Ed 3.1 – Background and Introduction (ID N114)
  • EC 60601-1 Ed 3.1 – Risk Management and General Requirements (ID N196)
  • EC 60601-1 Ed 3.1 – Protection Against Electrical Shock and Verifying Electrical Insulation (ID N197)
  • ISO 14971: 2007 Review (ID 78)
  • Preparing Risk Management Files & Which Techniques Apply (ID 83)
  • Integrating Risk Management into Your Quality Management System (ID 94)
  • Implications of EN ISO 14971: 2012 (ID N189)

Subject Matter Expert:

69 min

Related resources:

Case studies:

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