Training duration: 2 Days
Course Overview
This training program is designed to build your confidence in developing safe electrical medical devices that meet global type approval and regulatory requirements. Gain a structured approach for implementation, enabling development of products that adhere to high-quality and safety standards. Learn how to minimize risk early in the design and development phases by understanding and applying IEC 60601-1 and IEC 60601-1-2 standards along with integration of ISO 14971 principles for risk management.
What Will You Learn?
IEC 60601-1 and IEC 60601-1-2 standards govern the basic safety and essential performance of Medical Electrical Equipment and Systems.
This course will help you:
- Understand the scope and purpose of the IEC 60601-1 series and related standards
- Identify classification criteria and specific requirements for medical electrical devices
- Comprehend general safety and EMC (Electromagnetic Compatibility) test requirements
- Learn common medical electrical safety tests and their application
- Apply risk management principles in the design and testing of medical electrical equipment
- Understand documentation, marking, and labeling requirements for compliance
Course Outline
- Scope, Purpose, and Related Standards
- Key Changes in the Latest Editions (Scope of Changes)
- Normative References
- Standards and Classification of Medical Electrical Equipment
- Common Medical Electrical Safety Tests
- General Testing Requirements for Medical Electrical Equipment
- Classification of Medical Electrical Devices and Medical Electrical Systems
- Marking, Entry Points, and Documentation Requirements
- Electromagnetic Compatibility (EMC) Requirements
Who Should Attend?
- Quality Assurance and Regulatory Affairs Professionals
- Research & Development Engineers
- Auditors and Compliance Officers
- Professionals involved in medical device organizations operating in jurisdictions requiring compliance with IEC 60601 series standards
- Organizations expanding market reach to territories enforcing Medical Electrical Equipment safety testing
Pre-requisites: It is recommended that participants review the IEC 60601-1 and IEC 60601-1-2 standards prior to attending this course to maximize understanding.
Learning & Career Benefits
- Gain a comprehensive understanding of how to manufacture safe electrical medical devices
- Identify and apply specific requirements for classification of medical electrical equipment
- Review and understand common electrical safety testing methods
- Understand the general requirements and best practices for testing medical electrical equipment, including EMC
Examination & Certification
Participants will complete an online, open-book examination at the end of the course. A minimum score of 60% is required to pass. Successful candidates will be awarded a Course Completion Certificate by TÜV SÜD South Asia. Candidates who do not meet the passing criteria will receive a Certificate of Attendance.
Get in touch with us to know more.
Business address
TÜV SÜD Bangladesh (Pvt.) Ltd.
Update Tower, Level- 12, 8 & 14, 01 Shahjalal Avenue, Sector-06, Uttara Model Town, Dhaka-1230, Bangladesh
Tel: +88 02 58954115, 58954120, Ext-119
Email: [email protected]
