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The Role of IEC 60601 Around the World


Description

Once a manufacturer identifies the target market for their medical electrical equipment, it is necessary to identify applicable regulatory requirements in order to determine relevant standards to utilize in the design of the equipment.  Gain a high-level understanding of how the IEC 60601 series and the IECEE CB Scheme are used to demonstrate compliance with regulatory requirements worldwide.

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:

  • Compare and contrast the second edition of the IEC 60601 standard to the third edition of the standard
  • Trace the evolution of international and country-specific standards related to IEC 60601
  • Identify a sample of country-specific regulatory requirements and their relationship to IEC60601
  • List the worldwide benefits of compliance with IEC 60601
  • Explain the role of IEC and IECEE as global harmonization entities
  • Define the purpose of the CB Scheme

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.
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Media

Time Requirement

Cost

Web-Based 45 minutes $180.00
 









 
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