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ISO/TC 121/SC 3  - Lung ventilators and related equipment

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Standards and projects under the direct responsibility of ISO/TC 121/SC 3 Secretariat

Standard and/or projectStageICS
ISO 8185:2007
Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems
90.93 11.040.10
ISO 8359:1996
Oxygen concentrators for medical use -- Safety requirements
90.93 11.040.10
ISO 8359:1996/Amd 1:2012
60.60 11.040.10
ISO 9360-1:2000
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
90.60 11.040.10
ISO 9360-2:2001
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
90.60 11.040.10
ISO 10651-2:2004
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 2: Home care ventilators for ventilator-dependent patients
90.93 11.040.10
ISO 10651-3:1997
Lung ventilators for medical use -- Part 3: Particular requirements for emergency and transport ventilators
90.60 11.040.10
ISO 10651-4:2002
Lung ventilators -- Part 4: Particular requirements for operator-powered resuscitators
90.93 11.040.10
ISO 10651-5:2006
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 5: Gas-powered emergency resuscitators
90.93 11.040.10
ISO 10651-6:2004
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 6: Home-care ventilatory support devices
90.93 11.040.10
ISO/TR 13154:2009
Medical electrical equipment -- Deployment, implementation and operational guidelines for indentifying febrile humans using a screening thermograph
60.60 11.040.55
ISO 17510-1:2007
Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy equipment
90.92 11.040.10
ISO 17510-2:2007
Sleep apnoea breathing therapy -- Part 2: Masks and application accessories
90.92 11.040.10
ISO/WD 18562-1
Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process
20.20 11.040.10
ISO/WD 18562-2
Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter
20.20 11.040.10
ISO/WD 18562-3
Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs)
20.20 11.040.10
ISO/WD 18562-4
Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 4: Tests for leachables in condensate
20.20 11.040.10
ISO 18777:2005
Transportable liquid oxygen systems for medical use -- Particular requirements
90.20 11.040.99
ISO 18778:2005
Respiratory equipment -- Infant monitors -- Particular requirements
90.20 11.040.10
ISO 18779:2005
Medical devices for conserving oxygen and oxygen mixtures -- Particular requirements
90.92 11.040.10
ISO 23328-1:2003
Breathing system filters for anaesthetic and respiratory use -- Part 1: Salt test method to assess filtration performance
90.93 11.040.10
ISO 23328-2:2002
Breathing system filters for anaesthetic and respiratory use -- Part 2: Non-filtration aspects
90.20 11.040.10
ISO 23747:2007
Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
90.60 11.040.10
ISO 26782:2009
Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans
60.60 11.040.10
ISO 26782:2009/Cor 1:2009
60.60 11.040.10
IEC/CD 60601-1-2
Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic disturbances -- Requirements and tests
30.20 11.040.10
IEC 60601-1-8:2006
Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
90.92 11.040.10
IEC/CD 60601-1-8
Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
30.99 11.040.10
IEC 60601-1-8:2006/Amd 1:2012
60.60 11.040.10
IEC 60601-1-10:2007
Medical electrical equipment -- Part 1-10: General requirements for basic safety and essential performance -- Collateral standard: Requirements for the development of physiologic closed-loop controllers
90.93 11.040.10
IEC 60601-1-10:2007/DAmd 1
40.99 11.040.10
IEC 60601-1-11:2010
Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
60.60 11.040.10
IEC 60601-1-11:2010/Cor 1:2011
60.60 11.040.10
IEC/DIS 60601-1-12.2
Medical Electrical Equipment -- Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment
40.20 11.040.10
IEC 60601-2-12:2001
Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators -- Critical care ventilators
90.99 11.040.10
ISO 80601-2-12:2011
Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
60.60 11.040.10
ISO 80601-2-12:2011/Cor 1:2011
60.60 11.040.10
IEC 80601-2-30:2009
Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
60.60 11.040.10
IEC 80601-2-30:2009/FDAmd 1
50.20 11.040.10
ISO 80601-2-56:2009
Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
60.60 11.040.55
IEC 80601-2-59:2008
Medical electrical equipment -- Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening
60.60 11.040.55
ISO 80601-2-61:2011
Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
60.60 11.040.10
ISO/FDIS 80601-2-67
Medical electrical equipment -- Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
50.00 11.040.10
ISO/DIS 80601-2-69
Medical Electrical Equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
40.60 11.040.10
ISO/DIS 80601-2-70
Medical Electrical Equipment -- Part 2-70: Particular requirements for basic safety and essential performance of sleep apneoa breathing therapy equipment
40.20 11.040.10
IEC/CD 80601-2-71
Medical electrical equipment -- Part 2-71: Particular requirements for the basic safety and essential performance of functional oximeter equipment
30.60 11.040.10
ISO/CD 80601-2-72
Medical electrical equipment -- Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
30.60 11.040.10
ISO 81060-1:2007
Non-invasive sphygmomanometers -- Part 1: Requirements and test methods for non-automated measurement type
90.93 11.040.10
ISO 81060-2:2013
Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type
60.60 11.040.10
ISO 81060-2:2009/Cor 1:2011
60.60 11.040.10