On-Demand Webinar
Changes to IEC 60601-1 standard series and collaterals
Language: English
Speakers: Szabolcs Tóth, Zsuzsanna Braun and David Spencer
Before medical devices receive market approval, they must undergo conformity assessment, safety and EMC testing in accordance with the requirements of the IEC 60601-1 series of standards. With its collateral and particular standards, the series ensures the safety of medical electrical equipment. Nevertheless, manufacturers and retailers of medical devices currently have to cope with the latest changes of IEC 60601-1 (Ed 3.2), IEC 60601-1-2 (Ed 4.1) and further changes in related collaterals.
The IEC 60601-1-2:2014 + A1:2020 collateral standard provides the requirements for essential performance and basic safety in the presence of electromagnetic disturbances. Any changes to a standards can create concern for medical device manufacturers that must show compliance to the new standard once the regulatory bodies set a date. Several updates to the basic standard consist of corrections or clarifications to existing requirements, but some require effort on the part of manufacturers to upgrade from the previous version.
In our webinar, you will receive an overview of the changes in IEC 60601-1 (Ed 3.2), IEC 60601-1-2 (Ed 4.1) standards and related collaterals with regards to testing the safety and EMC of active medical devices. At the beginning of the webinar, we will also inform you about the services we can offer in our modern testing laboratories, including EMC and wireless testing.
Our agenda:
- Services of our laboratories (incl. EMC and wireless tests)
- Introduction to changes in IEC 60601-1:2005+A1:2012+A2:2020 standard
- Other changed collateral standards for the new edition of IEC 60601-1 (Ed 3.2)
- Electromagnetic compatibility and additional FDA wireless coexistence requirements
As a globally active testing and certification service provider, we are working intensively with all the requirements of IEC 60601. In our webinar, we therefore want to inform you competently and practically about the application.
Our Experts
Szabolcs Tóth
Global Segment Manager for Medical Device Testing, TÜV Rheinland
In his position as a laboratory manager and global segment manager, Szabolcs is responsible for the management and development of our testing services for medical devices with regards to safety and EMC evaluation as well. In 15 years at TÜV Rhineland, he gained brought experience about the needs of medical device manufacturers and retailers and has extensive background in laboratory testing and certification and in conformity assessment procedures.
Zsuzsanna Braun
Expert for Active Medical Devices, TÜV Rheinland
Zsuzsanna Braun, expert for active medical products in our test laboratories at Hungary, is responsible for a fast and professional product testing. She supports to ensure the safety and performance of active medical devices in accordance with various standards and regulatory requirements. In the past five years, the engineer has gained deep insights into the industry in various roles at TÜV Rheinland. Whether as an expert for active medical devices in the test laboratory, in the certification of product tests according to national and international standards or as an expert/auditor on site.
David Spencer
Laboratory and Field Manager for EMC testing, TÜV Rheinland
For more than eight years, David Spencer is working for TÜV Rheinland North America. Starting as a Regional Laboratory Manager, he made his way to the Director for Wireless Testing and Certification. He is a competent contact when it comes to the electromagnetic compatibility of medical products. On this aspect, the US American FDA has issued coexistence requirements.
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