Safety and EMC Requirements for Medical Devices based on IEC 60601

Qualifying People - Developing Future

Qualifying People - Developing Future

ABOUT THE COURSE

IEC 60601-1 & 2 is a standard that applies to the basic safety and the essential features of Medical Electrical Equipment and Medical Electrical Systems. As IEC 60601-1 & 2 becomes widely accepted across the globe, undergoing the training will help you minimise risk with redesign development right from the beginning. This topic will enable participants to understand how safe electrical medical device can be manufactured, along with common methods for risk assessment and integration of ISO 14961 principles. This is also helpful in identifying specific requirements and classification of medical electrical equipment. The course also helps participants with the following:

  • Become confident in how to develop a safe electrical medical device that meets type approval requirements
  • Demonstrate compliance to standard requirement
  • Have a structured approach while implementation
  • Ensure product development with desired quality and safety standards

COURSE CONTENT / OUTLINE

The Safety of Medical Electrical Equipment – IEC 60601-1 & 2 Training program shall cover the following modules:

  1. Scope, purpose, and related standards
  2. Scope of Changes
  3. Normative references
  4. Standards and Classifications
  5. Common Medical Electrical Safety Tests
  6. General requirements for Testing Medical Electrical equipment
  7. Classification of Medical Electrical devices of ME systems
  8. Marking, entries and documents of ME equipment
  9. EMC Requirements

WHO SHOULD ATTEND?

Quality Assurance and Regulatory Affairs professionals, R&D engineers, auditors within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in Medical Electrical equipment and Medical Safety Testing.

TRAINING DURATION

02 Days

PREREQUISITES

Delegates will benefit from reviewing the IEC 60601-1 and IEC 60601-2 standard before attending this course.

EXAM DETAILS (DURATION, PATTERN)

Participants will be assessed through an online examination (open book) at the end of the course. Minimum passing% criteria: 60%.

CERTIFICATION

Participants who score 60% and above in the online examination will be issued a TÜV SÜD South Asia’s Course Completion certificate. Unsuccessful candidates will be issued a certificate of attendance.

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