Course Description

IEC 60601-1 Ed 3.1 - Protection Against Electrical Shock, and verifying Electrical Insulation

Course Description:

This course provides an extensive review of IEC 60601-1 Edition 3.1 requirements regarding protection against electric shock and verification of electrical insulation.

The course is divided into three parts. The first part focuses on requirements for electrical shock protection, leakage currents, applied classifications, and defibrillation proofs. The second part covers the means of protection, including operator and patient protection, signal input and output, and insulation diagrams. The final part of the course concentrates on electrical insulation verification for the following items:

  • Insulation components
  • Spacing
  • Insulation coordination
  • Dielectric withstand
  • Transformers
  • Spaces filled by insulating components

Learning Objectives:

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

  • Apply the requirements of the standard to prevent electrical shock caused by medical electrical equipment
  • Determine where to find the requirements for different types of devices with regard to means of patient or operator protection
  • Differentiate which verification test are required for which devices
  • Implement a compliant design verification plan

Who Should Enroll:

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

Prerequisite Knowledge/Requirements:

The following material is required:

  • Basic knowledge of the background of IEC 60601-1 Edition 3.1 and its principles on risk management and collateral standards
  • EC 60601-1 Ed 3.1 – Background and Introduction (ID N114)
  • EC 60601-1 Ed 3.1 – Risk Management and General Requirements (ID N196)
  • 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:

94 min

Related resources:

Case studies:

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