Course Description

IEC 60601-1 Ed 3.1 - Protection Against Thermal and Other Hazards and Components

Course Description:

This course is divided into two parts, starting with a detailed outline of the requirements for protection against the following hazards:

  • Thermal
  • Normal temperatures
  • Fire prevention
  • Fire enclosures
  • Liquids
  • Biocompatibility
  • Interruption of power supply
  • Accuracy of controls
  • Hazardous output
  • Single fault conditions

The second and final part of this course evaluates IEC 60601-1 Edition 3.1 component requirements and provides relevant examples.


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Learning Objectives:

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

  • Understand the design and related testing requirements needed to ensure protection against hazardous components
  •  Apply critical component requirements

Who Should Enroll:

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

Prerequisite Knowledge/Requirements:

The following courses are required:

  • EC 60601-1 Ed 3.1 – Background and Introduction (ID N114)
  • 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)
  • 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)

Subject Matter Expert:
Brian Biersach

54 min

Related resources:

Case studies:

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Premium Account: € 162.00

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