BASIC SAFETY REQUIREMENTS FOR ACTIVE MEDICAL DEVICES

Key takeaways:

• Understand the overview of IEC 60601 series standards and relative standards
• Introduction to basic safety requirements of IEC 60601-1 
• Important technical requirements of IEC 60601-1

The IEC 60601 series and IEC 60601-1 standards become widely accepted in various countries such as the U.S., Canada, the EU, Japan, Brazil, and Australia. If you plan to export your equipment to these markets, consider the state-of-the-art (SOTA) requirements. In addition, the Thai FDA also recognised this standard for active medical devices. Remember that the latest IEC/ISO standards cannot be ignored after the typical transition period of 3-4 years has expired. To ensure entry into these and other markets, it is crucial that your equipment meets the necessary standards. Do not take risks when entering these key markets – stay current and compliant with the latest IEC standards.

To view the webinar, fill up the form now.

OUR WEBINAR WILL TACKLE THESE POINTS, FOCUSING ON:

• Overview of IEC 60601 series standards for active medical device
• Relationship between IEC 60601 and other relative standards e.g. ISO 14971 (Risk Assessment), IEC 62366 (Usability Engineering), IEC 62304 (Software Life Cycle)
• Introduction to basic safety requirements and important technical requirements of IEC 60601-1
• Q & A Session

ABOUT THE SPEAKER

Mr. Bancherd Kajchamaporn
Manager, PS MHS-Testing, TÜV SÜD Thailand

Bancherd granted Electrical Safety Expert for active medical device in TÜV SÜD from 2023 until now. He is responsible for the activities of testing for medical devices. In addition, he is also a factory inspector for product certification including the scope of active medical devices.

Previously, he had experience in product safety and EMC testing laboratories for household appliances in Thailand. The laboratory is accredited by Thai National Accreditation Body and also recognized as CBTL under IECEE CB scheme. He has more than 20 years of experience in product safety and EMC testing. He is currently also the IECEE CB technical assessor for HOUS category.