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North America’s Training Center

Medical Device Electrical Safety – IEC 60601-1 3rd Edition (Ed3.1) and Introduction to Electromagnetic Compatibility (EMC) Requirements

2-day training session

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About the training

IEC 60601-1 3rd Edition represents the benchmark for medical electrical equipment and compliance to the standard is a requirement in many countries including Europe (EN 60601-1:2006). Therefore, 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 (IEC 6060-1 3rd Edition).

sara jafari lne gmed

Dr. Sara Jafari, Ph.D. AIMD Design Dossier Evaluator and Medical Device Certification Project Manager

Dr. Sara Jafari is an Active Implantable Medical Device (AIMD) Design Dossier Evaluator and Medical Device Certification Project Manager at GMED North America. She is a biomedical engineer and received her Ph.D. in medical imaging from the University Pierre and Marie Curie  (Paris, France). Sara has extensive experiences in development of electro-medical device testing programs, including safety testing (IEC 60601-1 family of standards), evaluation of software (IEC 62304) and review of usability studies (IEC 62366-1) in addition to developing, testing and optimizing medical imaging sequences. Dr. Jafari is working as an active implantable medical device design dossier evaluator (EU directive and regulations) and certification project manager specialized in active medical devices at GMED North America.

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
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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
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Electrical safety requirements
  • Introduction to the electrical safety
  • Architecture of the IEC 60601-1 standards
  • Risk analysis
  • Definitions and vocabulary
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Technical requirements of IEC 60601-1 (illustrated by case studies)
  • Protection against electric shock
  • Protection against mechanical hazards and excessive radiation hazards
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Technical requirements of IEC 60601-1 (follow up)
  • Protection against excessive temperatures
  • Abnormal operation and single fault conditions
  • Construction rules
  • Marking and documentation
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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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