CSA Z10651-4:08 (R2023)

CSA Preface

This is the first edition of CAN/CSA-Z10651-4, Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 10651-4 (first edition, 2002-03-01). This CSA Standard, and CAN/CSA-Z10651-5-08, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators, replace CAN/CSA-Z8382-94, Resuscitators Intended for Use with Humans.

This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Anaesthetic Equipment, under the jurisdiction of the CSA Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.

Scope

This European Standard specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent.

Electrically- and gas-powered resuscitators are not covered by this European Standard.

NOTE Annex B contains rationale statements for this Part of this European Standard. The clauses and subclauses which have corresponding rationale statements are marked with R) after their number.