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

2- Day Training for RA/QA Professionals of the MD Industry

California | April 22-23, 2020 | Register Now! 

About the training

The Medical Device Electrical Safety (IEC 60601-1 3rd Edition) and Electromagnetic Compatibility (IEC 60601-1-2) standards offer the benchmark for medical electrical safety and device testing.

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 (IEC 60601-1 3rd Edition) and Electromagnetic Compatibility. This 2-day training covers the general details of the standards and features numerous built in knowledge checks that allow learners to apply and reinforce the new concepts throughout the training.

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 to conformity assessment requirements.

During this 2- day course, you will learn:

• To determine the applicable medical equipment requirements to design products for compliance
• To define insulation parameters and requirements
• To generate diagrams that determine creepage, clearance, insulation thickness and dielectric strength requirements
• To determine appropriate grounding / earthing, fire protection and mechanical requirements
• To create accurate and concise design and purchase specifications for critical components to achieve safety compliance goals
• To identify performance testing

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Keywords:  European Medical Devices Regulation 2017/745, Quality Management System (QMS), Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Electrical Safety (IEC 60601-1), Medical Device Electrical Safety, ISO 14971:2007, IEC 62366-1:2015)

WHO SHOULD ATTEND

• Medical Device Manufacturers: Senior Management, Regulatory Affairs Managers and Quality Managers, R& D specialists, Development, Manufacturing and Marketing Managers,
• Internal and external Auditors
• Importers
• Distributors

REQUIRED LEVEL

• Good knowledge and effective practice of the standard IEC 60601-1

The number of participants is maximized to fifteen to provide a stimulating and practical working environment.

EDUCATIONAL RESOURCES

• Presentations
• Practical working sessions
• Course evaluation
• Lunch meeting with the trainer (Lead Auditor and Technical File Assessor for high risk devices)

LEARNING OBJECTIVES

• Define insulation parameters and requirements
• Generate diagrams that determine creepage, clearance, insulation thickness and dielectric strength requirements
• Determine 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

DAY 1 

8:30 am to 9:00 am - Breakfast

9:00 am – 12:15 pm:

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

12:15 pm – 1:00 pm - Lunch

1:00 pm – 5:00 pm:

• Practical working sessions
• Group workshop
• Course Evaluation
• Summary and Discussion with the trainer

DAY 2

8:30 am to 9:00 am - Breakfast

9:00 am – 12:15 pm:

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

12:15 pm – 1:00 pm - Lunch

1:00 pm – 5:00 pm:

• Practical working sessions
• Group workshop
• Course Evaluation
• Summary and Discussion with the trainer

 Register Today ! 

About the trainer

Sara Jafari, PhD AIMD Design Dossier Evaluator and Medical Device Certification Project Manager Dr. Sara Jafari is an AIMD Design Dossier Evaluator and Medical Device Certification Project Manager at GMED North America. She is a biomedical engineer and received her PhD in medical imaging from Pierre and Marie Curie University (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.

About the trainer

Sébastien Rosset Certification Project Manager/ Lead Auditor Sebastien Rosset is a Certification Project Manager, and Lead Auditor at GMED North America. He received an Engineering degree specializing in measurement and automation from INSA CVL (France) and a master’s degree in electronics from the University of Montpellier II in France. Prior to joining GMED NA, Sebastien worked as a test engineer and technical manager in the Medical Device industry in the French National Laboratory (LNE, parent company of GMED). Sebastien has been working since 2011 on performing tests on active medical devices, following the standards IEC 60601, 62366, 62304.