Lung ventilators Part 4: Particular requirements for user-powered resuscitators

Designation Number:
CAN/CSA-Z10651-4
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.040.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range.

 

Example user-powered resuscitators include:

— self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic

recoil; and

 

NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of

environmental and emergency situations.

 

— flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow

from a medical gas source.

 

This document is also applicable to those accessories that are intended for use with resuscitators where

the characteristics of those accessories can affect the safety of the user-powered resuscitator.

 

Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.

 

This document is also applicable to point-of-use packaging.

 

This document does not specify the requirements for:

— gas-powered emergency resuscitators, which are given in ISO 10651-5;

— electrically-powered resuscitators;

— gas powered resuscitators for professional healthcare facilities; and

— anaesthetic reservoir bags, which are given in ISO 5362.

 

NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.

 

NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E.

 

NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.

 

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.