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Medical Device Electrical Safety – A Review of IEC 60601-1/A2

2-day training session

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About the training

GMED North America has created a 2-day training session, to equip medical device manufacturers with the right strategy to ensure their Medical Device Electrical Safety processes can withstand heightened scrutiny from NBs.

This comprehensive 2-day course covers the general details of the standard and features numerous built-in knowledge checks that allow learners to apply and reinforce the new concepts throughout the training. Designed to build a solid foundation, the course explores key aspects of the standard including its general philosophy, scope, structure, evolution, adaptation for use as national standards, the use of risk management and the requirements for markings and accompanying documents.

GMED North America has created a 2-day training session, to equip medical device manufacturers with the right understanding and implementation of the Medical Device Electrical Safety Standard – A Review of IEC 60601-1/A2.

Who Should Attend

  • R&D professionals
  • Auditors
  • QA/RA Managers

Learning Objectives

  • Determine the applicable medical equipment requirements to design products for compliance
  • Define insulation parameters and requirements
  • Determine creepage, clearance, insulation thickness and dielectric strength requirements
  • Identify appropriate grounding / earthing, fire protection and mechanical requirements
  • Create accurate and concise design and purchase specifications for critical components to achieve safety compliance goals
  • Identify performance testing, marking, documentation requirements
  • Identify the main electromagnetic compatibility (EMC) requirements according to IEC 60601-1-2 standard

Educational Resources

  • Presentations
  • Practical working sessions
  • Course evaluation

Check out the Program

Day 1 & 2
The normative architecture applicable to electromedical devices
  • General standard, product standards, collateral standards, national deviations
  • Harmonized standards in Europe
  • Building a strategy for conformity assessment
Electrical safety requirements
  • Introduction to the electrical safety
  • Architecture of the IEC 60601-1 standards
  • Risk analysis
  • Definitions and vocabulary
Technical requirements of IEC 60601-1 (illustrated by case studies)
  • Protection against electric shock
  • Protection against mechanical hazards and excessive radiation hazards
Technical requirements of IEC 60601-1 (follow up)
  • Protection against excessive temperatures
  • Abnormal operation and single fault conditions
  • Construction rules
  • Marking and documentation
Electromagnetic compatibility (EMC) requirements
  • Introduction to EMC
  • Conformity verification according to IEC 60601-1-2 (case studies)
  • Integrate CEM requirements into the design process and radiocommunication requirements
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We serve your passion for progress in the Medical Device Industry


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European Medical Devices Regulation (EU) 2017/745

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Risk management applied to Medical Devices (ISO 14971:2019)

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