CSA International Medical Device Series
IEC 60601-1, 3rd Edition and its Impact on the Certification Process for Test Houses and Manufacturers
This timely webinar series will provide an in-depth look into the most important changes of the IEC 60601-3, 3rd Edition and its impact on the design and certification process. Our facilitator will provide steps and processes of how and what a Test House will require to certify Medical Electrical Equipment according to the new Standard.
Session Objectives:- Preparing an appropriate safety test plan and safety risk management plan according to the adopted IEC 60601-1, 3rd Edition
- ISO 14971 Safety Risk Management review and accepatibility criteria from a Test House perspective - desktop approach
- Completing the Test Report IEC TRF 60601-1and providing the required supporting documentation