SR EN ISO 80601-2-74:2020
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2017)
ISO 80601-2-74:2017 applies to the basic safety and essential performance of a humidifier, also hereafter referred to as me equipment, in combination with its accessories, the combination also hereafter referred to as me system. ISO 80601-2-74:2017 is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier. EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or me equipment intended to control these heated breathing tubes (heated breathing tube controllers). NOTE 1 Heated breathing tubes and their controllers are me equipment and are subject to the requirements of IEC 60601-1. NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes. ISO 80601-2-74:2017 includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy fo
Status :
Withdrawn
Approval date : 4/30/2020
Withdrawal date : 9/30/2021
Number of pages : 102
ICS : 11.040.10 Anaesthetic, respiratory and reanimation equipment
Technical Committee : 377 - Medical devices
- Replaces SR EN ISO 8185:2009
- Replaced by SR EN ISO 80601-2-74:2021
RO