Workshop: Design and Control on IEC 60601-1 General Electrical Safety requirement for Medical Devices

This 1 day workshop provides coverage of the requirements for construction, documentation, markings, enclosures and components, as well as key certification requirements to assist you in designing products for compliance to IEC 60601.

• Understand Safety hazard contain in electrical medical device
• Interpret safety standards for electrical medical device:
• IEC 60601-1 standard structure
• Global harmonization
• Recognize the full scope of IEC 60601-1 and equipment classification
• Determine the applicable medical equipment requirements
• Generate diagrams that determine creepage, clearance, and dielectric strength requirements.
• Write accurate and concise design and purchase specifications for critical components to achieve safety compliance goals.
• Introduce the standard for homecare device (IEC60601-1-11)

Who Should Attend?

Managers, Engineers and anyone involved in the following:

• Product Innovation, Design & Development, Application & Research
• Product Quality, Validation, & Safety
• Regulatory Approval & Compliance
• Product Management

Course Fee:

• SGD 300 for non-member
• SGD 150 for SMF-MTIG member

Workshop Topics:

• Introduction to electrical safety for medical device
• IEC60601-1 standard structure & World requirement base on IEC60601-1
• Introduction to protection against the electric shock/excessive temperature, mechanical and related hazards
• Evaluation for Homecare device (IEC60601-1-11)

Speaker Profile:

Mr. Conga Chen is UL Senior Project Engineer. He has been working in product safety evaluation for electrical medical device for over 10 years. He has been focused on both product safety and performance evaluation for various IEC60601 part 2 standards (such as Infusion Pump, Surgical Light, NIBP, Patient Monitor and so on).
He holds the role as the reviewer for electrical safety for medical devices UL/AAMI/IEC 60601-1, technical auditor for UL DAP (Data acceptance program) and CTF for MED category.