RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
CAN/CSA-Z18778-08 (R2023)
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.040.55
11.040.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:

— intended for use in the home healthcare environment;

— intended for use by a lay operator;

— intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and

— intended for transit-operable use.

 

NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities.

 

This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.

 

EXAMPLE probes, cables distributed alarm system

Project need:

To maintain alignment with international requirements (new edition of adoption). This proposed New Edition is being developed at the request of Technical Committee on Perioperative Safety (Z251 TC). It will provide the industry with the latest requirements for the safety of perioperative practice covered by the standards listed in Annex A.

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.