Course Description

IEC 60601-1 Ed 3.1 - Background and Introduction

Course Description:

This first course in the IEC 60601-1 Edition 3.1 compliance program provides an overview of Edition 3.1 and how its standards are implemented internationally.

It offers a detailed review of how the Edition 3.1 standards, amendment, collaterals, and related standards are structured and executed, and concludes with a comparison between the second and third editions.

Learning Objectives:

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

  • Apply the standards to different geographic regions
  • Find information from different sections of the standards and collaterals
  • Execute methods from the third edition to new and existing devices

Who Should Enroll:

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

Prerequisite Knowledge/Requirements:

The following courses are required:

  • 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:
Brian Biersach

45 min

Related resources:

Case studies:

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