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Стандарт и/или проект находящийся в компетенции ISO/TC 121/SC 3 Секретариата Этап ICS
ISO 5369:1987
Breathing machines for medical use — Lung ventilators
95.99
ISO 7767:1988
Oxygen analyzers for monitoring patient breathing mixtures — Safety requirements
95.99
ISO 8185:1988
Humidifiers for medical use — Safety requirements
95.99
ISO 8185:1997
Humidifiers for medical use — General requirements for humidification systems
95.99
ISO 8185:1997/Cor 1:2001
Humidifiers for medical use — General requirements for humidification systems — Technical Corrigendum 1
95.99
ISO 8185:2007
Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems
95.99
ISO 8359:1988
Oxygen concentrators for medical use — Safety requirements
95.99
ISO 8359:1996
Oxygen concentrators for medical use — Safety requirements
95.99
ISO 8359:1996/Amd 1:2012
Oxygen concentrators for medical use — Safety requirements — Amendment 1
95.99
ISO 8382:1988
Resuscitators intended for use with humans
95.99
ISO 9360:1992
Anaesthetic and respiratory equipment — Heat and moisture exchangers for use in humidifying respired gases in humans
95.99
ISO 9703-1:1992
Anaesthesia and respiratory care alarm signals — Part 1: Visual alarm signals
95.99
ISO 9703-2:1994
Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
95.99
ISO 9703-3:1998
Anaesthesia and respiratory care alarm signals — Part 3: Guidance on application of alarms
95.99
ISO 9919:1992
Pulse oximeters for medical use — Requirements
95.99
ISO 9919:2005
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
Lung ventilators for medical use — Part 1: Requirements
95.99
ISO 10651-2:1996
Lung ventilators for medical use — Part 2: Particular requirements for home care ventilators
95.99
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
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
90.20
ISO 10651-6:2004
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
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 17510-1:2002
Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices
95.99
ISO 17510-1:2002/Cor 1:2004
Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices — Technical Corrigendum 1
95.99
ISO 17510-1:2007
Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment
95.99
ISO 17510-2:2003
Sleep apnoea breathing therapy — Part 2: Masks and application accessories
95.99
ISO 17510-2:2007
Sleep apnoea breathing therapy — Part 2: Masks and application accessories
95.99
ISO 17510:2015
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
60.60
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
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process — Amendment 1
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
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate — Amendment 1
10.99
ISO 18778:2005
Respiratory equipment — Infant monitors — Particular requirements
90.60
ISO 18779:2005
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
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
90.20
ISO 26782:2009/Cor 1:2009
Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans — Technical Corrigendum 1
60.60
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
IEC 60601-1-10:2007/Amd 1:2013
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 — Amendment 1
60.60
IEC 60601-1-10:2007/DAmd 2
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 — Amendment 2
40.60
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
95.99
IEC 60601-1-11:2010/Cor 1:2011
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 — Technical Corrigendum 1
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
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 — Amendment 1
40.60
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
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 — Amendment 1
40.60
IEC 60601-1-8:2003
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
IEC 60601-1-8:2003/Amd 1:2006
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 — Amendment 1
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
IEC 60601-1-8:2006/Amd 1:2012
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 — Amendment 1
60.60
IEC 60601-1-8:2006/DAmd 2
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 — Amendment 2
40.60
IEC 60601-2-12:2001
Medical electrical equipment — Part 2-12: Particular requirements for the safety of lung ventilators — Critical care ventilators
95.99
IEC/AWI 60601-2-23
Medical electrical equipment — Part 2-23: Transcutaneous partial pressure monitoring
20.00
IEC/DIS 60601-2-26
Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
40.98
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
Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
95.99
IEC 80601-2-30:2009/Amd 1:2013
Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers — Amendment 1
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
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
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
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
IEC/CD 80601-2-86
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
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
60.00
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
ISO 80601-2-12:2011/Cor 1:2011
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators — Technical Corrigendum 1
60.60
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
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
ISO 80601-2-56:2017/Amd 1:2018
Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement — Amendment 1
60.60
ISO 80601-2-61:2011
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 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 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 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 80601-2-85.2
Medical electrical equipment — Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
30.60
ISO/DIS 80601-2-67
Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
40.60
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
ISO/DIS 80601-2-70
Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
40.20
ISO/DIS 80601-2-87
Medical electrical equipment — Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
40.00
ISO/FDIS 80601-2-84
Medical electrical equipment — Part 2-84: Particular requirements for basic safety and essential performance of emergency and transport ventilators
50.00
ISO 81060-1:2007
Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
90.93
ISO 81060-2:2009
Non-invasive sphygmomanometers — Part 2: Clinical validation of automated measurement type
95.99
ISO 81060-2:2009/Cor 1:2011
Non-invasive sphygmomanometers — Part 2: Clinical validation of automated measurement type — Technical Corrigendum 1
95.99
ISO 81060-2:2013
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/FDAmd 1
Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1
50.20
ISO/AWI TS 81060-4
Non-invasive sphygmomanometers — Part 4: Requirements for devices intended for use during patient transport
20.00
ISO/DIS 81060-3
Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type
40.00
ISO/PRF TS 81060-5
Non-invasive sphygmomanometers — Part 5: Requirement for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
50.20

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