Scope of Standard & Equipment Classification

Description

IEC 60601 is intended only for those products that comply with the definition of Medical Electrical Equipment and Medical Electrical Systems and their accessories. Learn how to differentiate between equipment that is and is not covered under IEC 60601 and how to evaluate equipment based on the classifications found in Clause 6.

This module is included in the Designing for Compliance to IEC 60601-1 3rd Ed. eLearning bundle. Click here to access the full bundle.

Objectives

Upon completion of this course, you should be able to:

• Identify the types of products that fall within the scope of IEC 60601-1
• Define basic terminology relating to equipment classification
• List and explain the equipment classifications that appear in Clause 6
• Identify various symbols used to represent classifications of applied parts

Measurement:

Learning objectives will be measured by knowledge check questions throughout and a final case study.

Target Audience

• Product safety engineers
• Compliance engineers
• Product designers
• Regulatory approval staff
• Production support engineers
• Quality assurance staff
• Technical marketing professions

Continuing Education Units (CEUs)

• 0.1 IACET CEUs; contact your local jurisdiction for CEU recognition.