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Thread: CEN Standards Collection 329/370: CEN TC 215-Respiratory & Anaesthetic Equipment

  1. #1

    CEN Standards Collection 329/370: CEN TC 215-Respiratory & Anaesthetic Equipment

    full list:

    ENV 737-6:2003 Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum
    EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
    EN 1282-2:2005+A1:2009 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
    EN 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified)
    EN ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)
    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    EN ISO 5356-2:2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012)
    EN ISO 5359:2014 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO 5359:2014)
    EN ISO 5360:2016 Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
    EN ISO 5361:2012 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)
    EN ISO 5361:2012/AC:2012 Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Technical Corrigendum 1 (ISO 5361:2012)
    EN ISO 5364:2011 Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008)
    EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
    EN ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
    EN ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
    EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
    EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
    EN ISO 8836:2014 Suction catheters for use in the respiratory tract (ISO 8836:2014)
    EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)
    EN ISO 9170-2:2008 Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)
    EN ISO 9360-1:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)
    EN ISO 9360-2:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)
    EN ISO 10079-1:2015 Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)
    EN ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
    EN ISO 10079-3:2014 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
    EN ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
    EN ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
    EN ISO 10524-3:2006 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)
    EN ISO 10524-3:2006/A1:2013 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves - Amendment 1: Filtration and information to be supplied by the manufacturer (ISO 10524-3:2005/Amd 1:2013)
    EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
    EN ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
    EN ISO 10651-6:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
    EN ISO 11197:2016 Medical supply units (ISO 11197:2016)
    EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
    EN 13544-3:2001+A1:2009 Respiratory therapy equipment - Part 3: Air entrainment devices
    CR 13903:2000 General guidance on the equipment used for inhaled nitric oxide therapy
    EN ISO 14408:2016 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)
    CEN/TS 14507-1:2003 Inhalational nitric oxide systems - Part 1: Delivery systems
    CEN/TS 14507-2:2003 Inhalational nitric oxide systems - Part 2: Supply systems
    EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
    EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
    EN ISO 17510-1:2009 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
    EN ISO 17510-2:2009 Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
    EN ISO 18082:2014 Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014)
    EN ISO 18777:2009 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
    EN ISO 18778:2009 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
    EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
    EN ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005)
    EN ISO 21969:2009 High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
    EN ISO 23328-1:2008 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)
    EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
    EN ISO 23747:2015 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)
    EN ISO 26782:2009 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
    EN ISO 26782:2009/AC:2009 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans - Technical Corrigendum 1 (ISO 26782:2009/Cor 1:2009)
    EN ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011)
    EN ISO 80601-2-12:2011/AC:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators - Technical Corrigendum 1 (ISO 80601-2-12:2011/Cor 1:2011)
    EN ISO 80601-2-13:2012 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
    EN ISO 80601-2-55:2011 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011)
    EN ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
    EN ISO 80601-2-69:2014 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
    EN ISO 80601-2-72:2015 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)



    missing list:

    EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    CR 13903:2000 General guidance on the equipment used for inhaled nitric oxide therapy
    EN ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011)
    EN ISO 80601-2-13:2012 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
    EN ISO 80601-2-55:2011 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011)
    EN ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
    EN ISO 80601-2-69:2014 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)



    links:

    [link Point to another website Only the registered members can access] or

    [link Point to another website Only the registered members can access]


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  3. #2

    Re: CEN Standards Collection 329/340: CEN TC 215-Respiratory & Anaesthetic Equipment

    update:

    EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016) - added missing standard
    EN ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011) - added missing standard
    EN ISO 80601-2-13:2012 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) - added missing standard
    EN ISO 80601-2-55:2011 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011) - added missing standard
    EN ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) - added missing standard
    EN ISO 80601-2-69:2014 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) - added missing standard

    missing standard is:

    CR 13903:2000 General guidance on the equipment used for inhaled nitric oxide therapy


    new links:

    [link Point to another website Only the registered members can access]
    or

    [link Point to another website Only the registered members can access]


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  5. #3

    Re: CEN Standards Collection 329/340: CEN TC 215-Respiratory & Anaesthetic Equipment

    thanks

  6. #4

    Re: CEN Standards Collection 329/340: CEN TC 215-Respiratory & Anaesthetic Equipment

    update:

    EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) - added missing standard
    EN ISO 5366:2016 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016) - added missing standard


    missing are now:

    EN ISO 5364:2016 Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
    CR 13903:2000 General guidance on the equipment used for inhaled nitric oxide therapy
    EN ISO 19054:2006+A1:2016 Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)


    links:

    [link Point to another website Only the registered members can access]
    or

    [link Point to another website Only the registered members can access]


  7. #5

    Re: CEN Standards Collection 329/370: CEN TC 215-Respiratory & Anaesthetic Equipment

    update:

    EN versions:
    ENV 737-6:2003 Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum


    better quality:
    EN ISO 5360:2016 Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
    EN ISO 11197:2016 Medical supply units (ISO 11197:2016)
    EN ISO 14408:2016 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)
    EN ISO 18082:2014 Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014)


    still missing:
    EN ISO 5364:2016 Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
    CR 13903:2000 General guidance on the equipment used for inhaled nitric oxide therapy
    EN ISO 19054:2006/A1:2016 Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)


    new link:

    [link Point to another website Only the registered members can access]


  8.    Spons.


  9. #6

    Re: CEN Standards Collection 329/370: CEN TC 215-Respiratory & Anaesthetic Equipment

    update:

    BQ* missing* EN:

    EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
    EN ISO 5364:2016 Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
    EN ISO 5366:2016 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
    EN ISO 10651-6:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
    CEN/TS 14507-2:2003 Inhalational nitric oxide systems - Part 2: Supply systems
    EN ISO 18778:2009 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
    EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
    EN ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005)
    EN ISO 19054:2006/A1:2016 Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)
    EN ISO 26782:2009 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)


    the missing 1 is:

    CR 13903:2000 General guidance on the equipment used for inhaled nitric oxide therapy

    [link Point to another website Only the registered members can access]


  10. #7

    Re: CEN Standards Collection 329/370: CEN TC 215-Respiratory & Anaesthetic Equipment

    thanks a lot for Mr. BornToSin. here you are the missing code*but it was PD CR 13903-2001* maybe a little help.
    Attached Files Attached Files

  11. #8

    Re: CEN Standards Collection 329/370: CEN TC 215-Respiratory & Anaesthetic Equipment

    thanx* that's the one missing....PD is only "Published Document" which means that BSI accepted it* and since is not standard as a standard* then tehcnical specification or similiar* that's why have the PD in title

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