Regulatory Aspects of Critical Care Mechanical Ventilators: Basic Safety and Essential Performance

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Join our live webinar to learn about critical safety aspects in the regulation and testing of critical care mechanical ventilators.

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.

Agenda

Introduction to speakers
Objective
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
Examples

Target Audience

This webinar is intended for manufacturers of medical equipment, medical devices test engineers and regulatory compliance professionals for the EUT market.

Presenter

Antonio Velasco Mota
Medical Devices Test Engineer
SGS

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.