The list of new standards, current draft standards and projects is a selection that might be relevant for our clients. It therefore does not claim to be complete. The compilation has been made very carefully and serves as an overview for you. However, errors cannot be excluded, and we cannot assume any liability.
The selection draws information from the following standards committees:
Biocompatibility evaluation of breathing gas pathways in healthcare applications
Part 4: Tests for leachables in condensate
Lung ventilators for medical use
Particular requirements for basic safety and essential performance
Part 5: Gas-powered emergency resuscitator
Anaesthetic and respiratory equipment
Tracheal tubes and connectors (ISO/DIS 5361:2021)
General requirements and test methods (ISO/DIS 20126:2021)
Information to be supplied by the manufacturer
Medical electrical equipment
Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
Continue reading Standards and Standard Projects from March 2021.