• CAN/CSA-ISO 10079-1:16

    Current The latest, up-to-date edition.

    Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01)

    Available format(s):  Hardcopy, PDF

    Language(s):  English - French, French

    Published date:  01-01-2016

    Publisher:  Canadian Standards Association

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Cleaning, disinfection and sterilization
    6 Design requirements
    7 Operational requirements
    8 Physical requirements for suction equipment for
       field use
    9 Performance requirements for vacuum level and
       flowrate
    10 Resistance to environment of suction equipment
       for field and/or transport use
    11 Information to be supplied by the manufacturer
       (labelling and instructions for use)
    Annex A (normative) - Test methods
    Annex B (informative) - Rationale statement
    Annex C (informative) - Lumen size and its effect
            on flowrate
    Annex D (informative) - Schematic of suction
            equipment
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines safety and performance requirements for electrically powered medical and surgical suction equipment.

    Scope - (Show below) - (Hide below)

    CSA Preface This is the second edition of CAN/CSA-ISO 10079-1, Medical suction equipment Part 1: Electrically powered suction equipment, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 10079-1 (third edition, 2015-11-01). It supersedes the previous edition published in 2003 as CAN/CSA-Z10079-1 (adopted ISO 10079-1:1999). For brevity, this Standard will be referred to as "CAN/CSA-ISO 10079-1" throughout. Scope This part of ISO 10079 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field and transport use. This part of ISO 10079 does not apply to the following: a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors; b) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; c) syringes; d) dental suction equipment; e) anaesthetic gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) mucus extractors including neonatal mucus extractors; i) suction equipment where the collection container is downstream of the vacuum pump; j) ventouse (obstetric) equipment; k) suction equipment marked for endoscopic use only; l) plume evacuation systems.

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

    Development Note Supersedes CSA Z10079.1. (07/2016)
    Document Type Standard
    Product Note NEW CHILD AMD 1 2019 IS NOW ADDED
    Publisher Canadian Standards Association
    Status Current
    Supersedes

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

    ISO 8836:2014 Suction catheters for use in the respiratory tract
    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    ISO 10079-2:2014 Medical suction equipment Part 2: Manually powered suction equipment
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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