• CAN/CSA-Z10651-4-08 (R2018)

    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

    Publisher:  Canadian Standards Association

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Development Note Together with CSA Z10651-5, it supersedes CSA Z8382. (04/2008)
    Document Type Standard
    Product Note Reconfirmed EN
    Publisher Canadian Standards Association
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective