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Designing for Compliance to IEC 60601-1: Transition to the 3rd Edition


Description

This one-day workshop, presented by experienced UL engineers who evaluate products for certification to U.S. and international standards for medical equipment, covers the changes that will be brought about by the issuance of 60601-1, 3rd Edition. This workshop will help you gain a thorough understanding of how to prepare for those changes.

3rd edition differences include:

  • Impact of collateral standards on requirements for compliance/certification
  • Explanation of the normative reference, ISO 14971 into the general standard
  • Changes in the definitions of and approach towards the evaluation of applied parts
  • Changes in the definitions of leakage currents and introduction of new leakage current measurements
  • Separate isolation requirements for patients and users (e.g. operators) of the equipment
  • Use of insulation coordination in determining creepage/clearance values
  • Introduction of systems information into the general standard including essential performance concepts
  • Side by side comparison of select 2nd and 3rd edition mechanical hazard issues
  • Identification of new mechanical hazard areas including noise, vibration and acoustic energy
  • Transformer testing changes
  • Alternative fire control methods
  • Marking changes including electronic versions
  • Component requirements (new)
  • Use with oxygen requirements (new)

Current 2nd edition workshop topics include:

 

  • The full scope of IEC 60601-1, including the current U.S., Canadian and European deviations (UL 60601-1, CAN/CSA C22.2 No. 601.1 and EN 60601-1)
  • Determining the applicable medical equipment requirements to design products for compliance
  • Writing accurate and concise design and purchase specifications for critical components to achieve safety compliance goals
  • Generating diagrams which determine creepage, clearance, insulation thickness and dielectric strength requirements
  • Grounding/earthing
  • Performance testing
  • Insulation parameters and requirements
  • Insights into world certification schemes and agreements affecting medical equipment

Objectives

Upon completion of this workshop, you will be able to discuss the changes from IEC 60601-1-2nd edition to IEC 60601-1 3rd Edition in the following areas:

  • Risk analysis- ISO 14971
  • Electrical hazards
  • Medical electrical systems
  • Mechanical hazards
  • Temperatures
  • Fire enclosure concept
  • Markings and documentation
  • Component requirements
  • Oxygen requirements

Target Audience

  • Product safety engineers
  • Compliance engineers
  • Product designers
  • Technical marketing professionals
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Media

Time Requirement

Cost

Instructor-Led 1 day $840.00

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