• CSA ISO 10079-3:14 (R2019)

    Current The latest, up-to-date edition.

    Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01)

    Available format(s):  Hardcopy, PDF

    Language(s):  English, French

    Published date:  01-01-2014

    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 field and transport use suction
       equipment
    9 Performance requirements for vacuum level and flowrate
    10 (*)Resistance to environment of suction equipment for field
       and/or transport use
    11 Marking
    12 Information to be supplied by the manufacturer
    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)

    CSA Preface This is the second edition of CAN/CSA-ISO 10079-3, Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 10079-3 (third edition, 2014-05-01). It supersedes the previous edition published in 2003 as CAN/CSA-Z10079-3, Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (adopted ISO 10079-3:1999, with Canadian deviations). This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope This part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venture suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems. The equipment can be stand-alone or part of an integrated system. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079. 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-piece such as suction catheters, Yankauer sucker and suction tips; c) syringes; d) dental suction equipment; e) anaesthetic gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) closed systems for wound drainage; i) mucus extractors, including neonatal mucus extractors; j) ventouse (obstetric) equipment; k) breast pumps; l) liposuction; m) uterine aspiration; n) plume evacuation systems.

    Scope - (Show below) - (Hide below)

    CSA Preface This is the second edition of CAN/CSA-ISO 10079-3, Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 10079-3 (third edition, 2014-05-01). It supersedes the previous edition published in 2003 as CAN/CSA-Z10079-3, Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (adopted ISO 10079-3:1999, with Canadian deviations). This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope This part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venture suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems. The equipment can be stand-alone or part of an integrated system. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079. 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-piece such as suction catheters, Yankauer sucker and suction tips; c) syringes; d) dental suction equipment; e) anaesthetic gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) closed systems for wound drainage; i) mucus extractors, including neonatal mucus extractors; j) ventouse (obstetric) equipment; k) breast pumps; l) liposuction; m) uterine aspiration; n) plume evacuation systems.

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

    Development Note Supersedes CSA Z10079.3. (09/2014)
    Document Type Standard
    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
    ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10079-2:2014 Medical suction equipment Part 2: Manually powered suction equipment
    CGA V 5 : 2008(R2013) DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS)
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 18082:2014 Anaesthetic and respiratory equipment Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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