Medical Device Electrical Safety – IEC 60601-1 A1/A2
2-day training session (4 consecutive half-days)
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.
Ali Homaida Senior Compliance Engineer – Active Medical Devices at 601 Consultancy Ltd
Ali Homaida is an accomplished IEC 60601-1 Compliance Engineer, Consultant, Product Reviewer, and Trainer in the medical device industry.
With a background in biomedical engineering, he has worked with test houses in compliance assessment of electrical medical devices including safety testing, risk management files evaluation, usability engineering, and medical devices software.
Who Should Attend
- Medical Device Manufacturers: Quality Assurance Specialists, Regulatory Specialists, R&D Engineers, Risk Management Team Members, and Product Specialists
- Auditor and Product Reviewers for Active Medical Devices
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
- Learn the additions/differences brought by Amendment A2 (2020)
Educational Resources
- Presentations
- Practical working sessions
- Course evaluation
Check out the Program
- Introduction
- Definitions and vocabulary
- Basic Safety and Essential Performance Aspects
- Classification of ME EQUIPMENT and ME SYSTEMS
- Markings and Documentation Requirements
- Protection against electric shocks
- Critical Components
- Power Supply and Batteries
- Mechanical Hazards
- Protection against unwanted and excessive radiation hazards
- Protection against excessive temperatures
- Accuracy of controls and instruments and protection against hazardous outputs
- Hazardous situations and fault conditions
- Programmable Electrical Medical Systems (PEMS)
- Construction of ME Equipment
- Construction rules
- Medical Electrical System (clause 16)
- Amendment 2: IEC 60601-1:2005/AMD2:2020
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