Standards catalogue

ISO/TC 121/SC 3

Respiratory devices and related equipment used for patient care

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Standard and/or project under the direct responsibility of ISO/TC 121/SC 3 Secretariat Stage ICS
ISO 5369:1987 [Withdrawn]
Breathing machines for medical use -- Lung ventilators
95.99
ISO 7767:1988 [Withdrawn]
Oxygen analyzers for monitoring patient breathing mixtures -- Safety requirements
95.99
ISO 8185:1988 [Withdrawn]
Humidifiers for medical use -- Safety requirements
95.99
ISO 8185:1997 [Withdrawn]
Humidifiers for medical use -- General requirements for humidification systems
95.99
95.99
ISO 8185:2007 [Withdrawn]
Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems
95.99
ISO 8359:1988 [Withdrawn]
Oxygen concentrators for medical use -- Safety requirements
95.99
ISO 8359:1996 [Withdrawn]
Oxygen concentrators for medical use -- Safety requirements
95.99
95.99
ISO 8382:1988 [Withdrawn]
Resuscitators intended for use with humans
95.99
ISO 9360:1992 [Withdrawn]
Anaesthetic and respiratory equipment -- Heat and moisture exchangers for use in humidifying respired gases in humans
95.99
ISO 9703-1:1992 [Withdrawn]
Anaesthesia and respiratory care alarm signals -- Part 1: Visual alarm signals
95.99
ISO 9703-2:1994 [Withdrawn]
Anaesthesia and respiratory care alarm signals -- Part 2: Auditory alarm signals
95.99
ISO 9703-3:1998 [Withdrawn]
Anaesthesia and respiratory care alarm signals -- Part 3: Guidance on application of alarms
95.99
ISO 9919:1992 [Withdrawn]
Pulse oximeters for medical use -- Requirements
95.99
ISO 9919:2005 [Withdrawn]
Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
95.99
ISO 10651-1:1993 [Withdrawn]
Lung ventilators for medical use -- Part 1: Requirements
95.99
ISO 10651-2:1996 [Withdrawn]
Lung ventilators for medical use -- Part 2: Particular requirements for home care ventilators
95.99
ISO 10651-2:2004 [Withdrawn]
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 2: Home care ventilators for ventilator-dependent patients
95.99
ISO 10651-3:1997
Lung ventilators for medical use -- Part 3: Particular requirements for emergency and transport ventilators
90.92
ISO 10651-4:2002
Lung ventilators -- Part 4: Particular requirements for operator-powered resuscitators
90.93
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
ISO 10651-6:2004 [Withdrawn]
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 6: Home-care ventilatory support devices
95.99
ISO/TR 13154:2009 [Withdrawn]
Medical electrical equipment -- Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
95.99
ISO/TR 13154:2017
Medical electrical equipment -- Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
60.60
ISO 17510:2015
Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
60.60
ISO 17510-1:2002 [Withdrawn]
Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy devices
95.99
95.99
ISO 17510-1:2007 [Withdrawn]
Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy equipment
95.99
ISO 17510-2:2003 [Withdrawn]
Sleep apnoea breathing therapy -- Part 2: Masks and application accessories
95.99
ISO 17510-2:2007 [Withdrawn]
Sleep apnoea breathing therapy -- Part 2: Masks and application accessories
95.99
ISO 18562-1:2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process
60.60
ISO 18562-1:2017/NP Amd 1 [Under development]
10.99
ISO 18562-2:2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter
60.60
ISO 18562-3:2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs)
60.60
ISO 18562-4:2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 4: Tests for leachables in condensate
60.60
ISO 18562-4:2017/NP Amd 1 [Under development]
10.99
ISO 18778:2005
Respiratory equipment -- Infant monitors -- Particular requirements
90.60
ISO 18779:2005 [Withdrawn]
Medical devices for conserving oxygen and oxygen mixtures -- Particular requirements
95.99
ISO 20789:2018
Anaesthetic and respiratory equipment -- Passive humidifiers
60.60
ISO/TR 21954:2018
Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator
60.60
ISO 23747:2007 [Withdrawn]
Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
95.99
ISO 23747:2015
Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
60.60
ISO 26782:2009
Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans
90.93
60.60
IEC 60601-1-8:2003 [Withdrawn]
Medical electrical equipment -- Part 1-8: General requirements for safety -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
95.99
95.99
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
90.93
60.60
IEC 60601-1-8:2006/DAmd 2 [Under development]
40.20
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
60.60
IEC 60601-1-10:2007/DAmd 2 [Under development]
40.20
IEC 60601-1-11:2010 [Withdrawn]
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
95.99
95.99
IEC 60601-1-11:2015
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
IEC 60601-1-11:2015/DAmd 1 [Under development]
40.20
IEC 60601-1-12:2015
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
60.60
IEC 60601-1-12:2015/DAmd 1 [Under development]
40.20
IEC 60601-2-12:2001 [Withdrawn]
Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators -- Critical care ventilators
95.99
IEC/AWI 60601-2-23 [Under development]
Medical electrical equipment -- Part 2-23: Transcutaneous partial pressure monitoring
20.00
IEC/DIS 60601-2-26 [Deleted]
Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
40.98
ISO/DIS 80601-2-84 [Under development]
Medical electrical equipment -- Part 2-84: Particular requirements for basic safety and essential performance of emergency and transport ventilators
40.60
ISO/CD 80601-2-85 [Under development]
Medical electrical equipment -- Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
30.20
IEC/CD 80601-2-86 [Under development]
Medical electrical equipment -- Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables and leadwires
30.99
ISO 80601-2-12:2011
Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
90.92
60.60
ISO/FDIS 80601-2-12 [Under development]
Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
50.00
IEC 80601-2-26:2019
Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
60.60
IEC 80601-2-30:2009 [Withdrawn]
Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
95.99
95.99
IEC 80601-2-30:2018
Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
60.60
IEC 80601-2-49:2018
Medical electrical equipment -- Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
60.60
ISO 80601-2-56:2009 [Withdrawn]
Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
95.99
ISO 80601-2-56:2017
Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
60.60
60.60
IEC 80601-2-59:2008 [Withdrawn]
Medical electrical equipment -- Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening
95.99
IEC 80601-2-59:2017
Medical electrical equipment -- Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
60.60
ISO 80601-2-61:2011 [Withdrawn]
Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
95.99
ISO 80601-2-61:2017
Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
60.60
ISO 80601-2-67:2014
Medical electrical equipment -- Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
90.92
ISO/DIS 80601-2-67 [Under development]
Medical electrical equipment -- Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
40.00
ISO 80601-2-69:2014
Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
90.92
ISO/DIS 80601-2-69 [Under development]
Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
40.00
ISO 80601-2-70:2015
Medical electrical equipment -- Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
90.92
ISO/CD 80601-2-70 [Under development]
Medical electrical equipment -- Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
30.92
IEC 80601-2-71:2015
Medical electrical equipment -- Part 2-71: Particular requirements for the basic safety and essential performance of functional Near-Infrared Spectroscopy (NIRS) equipment
60.60
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
60.60
ISO 80601-2-74:2017
Medical electrical equipment -- Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
60.60
ISO 80601-2-79:2018
Medical electrical equipment -- Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
60.60
ISO 80601-2-80:2018
Medical electrical equipment -- Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
60.60
ISO/CD 80601-2-87 [Under development]
Medical electrical equipment -- Part 2-87: Particular requirements for basic safety and essential performance of high-frequency critical care ventilators
30.20
ISO 81060-1:2007
Non-invasive sphygmomanometers -- Part 1: Requirements and test methods for non-automated measurement type
90.93
ISO 81060-2:2009 [Withdrawn]
Non-invasive sphygmomanometers -- Part 2: Clinical validation of automated measurement type
95.99
95.99
ISO 81060-2:2013 [Withdrawn]
Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type
95.99
ISO 81060-2:2018
Non-invasive sphygmomanometers -- Part 2: Clinical investigation of intermittent automated measurement type
60.60
ISO 81060-2:2018/DAmd 1 [Under development]
40.20
ISO/CD 81060-3 [Under development]
Non-invasive sphygmomanometers -- Part 3: Clinical investigation of continuous automated measurement type
30.20
ISO/AWI TS 81060-4 [Under development]
Non-invasive sphygmomanometers -- Part 4: Requirements for devices intended for use during patient transport
20.00
ISO/DTS 81060-5 [Under development]
Non-invasive sphygmomanometers -- Part 5: Requirement for the repeatability and reproducibility of NIBP simulators for testing
30.20

No matching records found