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.
- 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
Following the presentation, our experts will answer your individual questions. In the afternoon session at 6 pm our expert for the American market, David Spencer, will explain the FDA wireless coexistence requirements. After the webinar, you receive the recording from the afternoon session with him, no matter which session you joined. 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.