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CAN/CSA-Z10651-4-08 (R2018)

Current
Current

The latest, up-to-date edition.

Lung Ventilators - Part 4: Particular Requirements for Operator-Powered Resuscitators (Adopted ISO 10651-4:2002, first edition, 2002-03-01, with Canadian deviations)
Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2008

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Connectors
5 Operational requirements
6 Ventilatory requirement
7 Storage and operating conditions
8 Requirements for resuscitator, or parts, supplied sterile
9 Marking
10 Information to be provided by the manufacturer in operating
   and maintenance instructions
Annex A (normative) - Test methods
Annex B (informative) - Rationale
Bibliography

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. 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.

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. 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.

DevelopmentNote
Together with CSA Z10651-5, it supersedes CSA Z8382. (04/2008)
DocumentType
Standard
ISBN
978-1-54436-666-8
Pages
0
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Current
Supersedes

Standards Relationship
ISO 10651-4:2002 Identical

EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN 980:2008 Symbols for use in the labelling of medical devices
EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors

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