Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

Designation Number:
CAN/CSA-C22.2 NO. 80601-2-74
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Standard
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

A new standard of IEC/ISO 80601-2-74 has been published, the scope of this project is to adopt the new IEC standard and bring the current CAN/CSA publication up to date. The scope of this international standard is specifies requirements for the safety and essential performance of respiratory humidifying equipment. Hereafter referred to as ME EQUIPMENT, in combination with its ACCESSORIES, the combination also hereafter referred to as ME SYSTEM. This document 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. This document 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 for tracheostomy PATIENTS

Project need:

This proposed New Standard is being developed at the request of the certification bodies, and medical equipment suppliers. It will provide the industry with a standard that will meet the Canadian industry needs and allows certification bodies to keep the certification program up to date

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.