High demand for critical care medical equipment during the COVID-19 pandemic led to an increase in the manufacture and certification of equipment. This also triggered temporary regulatory changes in diverse territories.
This webinar will highlight critical aspects of safety and performance testing for intensive care mechanical ventilators.
- Introduction to speakers
- Summary of existing regulations
- Recommendations on regulation and testing for critical care mechanical ventilators
- Standards and their key points:
- IEC 60601-1:2005
- IEC 60601-1-2:2014
- ISO 80601-2-12:2011
- What must be tested in a critical care mechanical ventilator, and how to do it accordance with the standards
This webinar is intended for manufacturers of medical equipment, medical devices test engineers and regulatory compliance professionals for the EUT market.
Antonio Velasco Mota
Medical Devices Test Engineer
Antonio has a Master’s (MSc) degree in Biomedical Engineering from the Universidad Politecnica de Madrid and a Master’s degree in Mathematics from the Universidad de Castilla-La Mancha.
Prior to joining SGS, Antonio spent seven years working in the development of active medical equipment as a software engineer, product specialist and product manager for critical care mechanical ventilation equipment in a German manufacturing company. Antonio has five years experience testing medical devices at SGS.
For more information, please contact:
Global Marketing Manager
t: +49 40 30101 286