Training Program on Safety & EMC Requirements of Medical Devices based on IEC 60601-1-1, IEC 60601-1-2

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. 

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

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

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

• Top of Form Understand how safe electrical medical devices can be manufactured
• Identify specific requirements and classification of medical electrical equipment
• Review the common Medical Electrical Safety Tests
• Understand the general requirements for Testing Medical Electrical equipment

Participants will be assessed through an online examination (open book) at the end of the course. The minimum passing criteria for the examination is 60%. 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.

1. When can I get the certificate?

IEC 60601 Safety and EMC Requirements for Medical Devices Training certification will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?

One day before the commencement of the training program.

3. How do I pay the fees for training and examination?

Online mode

4. What are the benefits of the IEC 60601 Safety and EMC Requirements for Medical Devices Training Program?

• Understand how safe electrical medical device can be manufactured

• Identify specific requirements and classification of medical electrical equipment
• Review the common Medical Electrical Safety Tests
• Understand the general requirements for Testing Medical Electrical equipment

5. Is there any refund policy for the paid fees?

Please refer to Cancellation and Refund policy page.