11.040.10 - Anaesthetic, respiratory and reanimation equipment
ICS 11.040.10 Details
Anaesthetic, respiratory and reanimation equipment
Wiederbelebungs-, Anastesie- und Beatmungsgerate
Matériel d'anesthésie, de réanimation et respiratoire
Anestezijska, respiratorna in reanimacijska oprema
General Information
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This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.
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This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing). NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected. NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application. NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards. NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.
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Full revision of currently published 2014 version. Additionally, expand scope to include plume evacuation systems for endoscopic procedures (e.g. minimally invasive, laparoscopic).
The scope is now the following:
This Standard specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices. It is applicable to:
a) portable and mobile plume evacuation systems,
b) local stationary plume evacuation systems,
c) dedicated central pipeline systems for plume evacuation systems, and
d) plume evacuation systems integrated into other equipment (e.g. laser equipment).
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This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a) a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b) the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c) to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a) flowmeters;
b) flowgauge FCDs; and
c) fixed orifice FCDs.
NOTE Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
— oxygen;
— oxygen 93 %;
— nitrous oxide;
— medical air;
— carbon dioxide;
— oxygen/nitrous oxide mixture 50/50 (% volume fraction);
— oxygen-enriched air;
— helium;
— xenon; and
— specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a) for use with gases for driving surgical tools;
b) an integral part of a regulator (see ISO 10524-1:2018); or
c) an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).
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This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
This document applies to all types of plume evacuation systems (PESs), including
a) portable;
b) mobile;
c) stationary, including dedicated central pipelines;
d) PESs integrated into other equipment;
e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a) surgical facilities;
b) medical offices;
c) cosmetic treatment facilities;
d) medical teaching facilities;
e) dental clinics;
f) veterinary facilities.
This document provides guidance on the following aspects of PESs:
a) importance;
b) purchasing;
c) design;
d) manufacture;
e) documentation;
f) function;
g) performance;
h) installation;
i) commissioning;
j) testing;
k) training;
l) use;
m) risk assessment;
n) servicing;
o) maintenance.
This document does not apply to the following:
a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b) medical vacuum systems which are covered in ISO 7396-1;
c) heating, ventilation, and air-conditioning (HVAC) systems;
d) aspects of laser safety other than airborne contamination; and
e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.
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This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices. This document applies to all types of plume evacuation systems (PESs), including a) portable; b) mobile; c) stationary, including dedicated central pipelines; d) PESs integrated into other equipment; e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic) This document applies to all healthcare facilities where PESs are used, including, but not limited to a) surgical facilities; b) medical offices; c) cosmetic treatment facilities; d) medical teaching facilities; e) dental clinics; f) veterinary facilities. This document provides guidance on the following aspects of PESs: a) importance; b) purchasing; c) design; d) manufacture; e) documentation; f) function; g) performance; h) installation; i) commissioning; j) testing; k) training; l) use; m) risk assessment; n) servicing; o) maintenance. This document does not apply to the following: a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2; b) medical vacuum systems which are covered in ISO 7396-1; c) heating, ventilation, and air-conditioning (HVAC) systems; d) aspects of laser safety other than airborne contamination; and e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.
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This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a) a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b) the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c) to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a) flowmeters;
b) flowgauge FCDs; and
c) fixed orifice FCDs.
NOTE Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
— oxygen;
— oxygen 93 %;
— nitrous oxide;
— medical air;
— carbon dioxide;
— oxygen/nitrous oxide mixture 50/50 (% volume fraction);
— oxygen-enriched air;
— helium;
— xenon; and
— specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a) for use with gases for driving surgical tools;
b) an integral part of a regulator (see ISO 10524-1:2018); or
c) an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).
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This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024. This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas to the patient. This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing. This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device. This document does not address contact with drugs or anaesthetic agents. If a medical device or accessory is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient.
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This document specifies tests for the emissions of volatile organic substances from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of volatile organic substances that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests. NOTE Gaseous emission of volatile organic substances includes emissions of volatile organic compounds, semi-volatile organic compounds and very volatile organic compounds. This document addresses potential contamination of the gas stream arising from the gas pathways of medical devices or accessories, which is then conducted to the patient. This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing. This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series. This document is intended to be read in conjunction with ISO 18562-1.
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This document specifies: — the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments; — the general categorization of gas pathways based on the nature and duration of their contact with the gas stream; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the gas pathway; — the assessment of the biological safety of the gas pathway. This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, in normal use and normal condition. This document does not cover biological hazards arising from mechanical damage. The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances. This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient. This document applies over the expected lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use). This document does not address biological evaluation of the surfaces of medical devices that have direct contact with the patient or user. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).
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This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,25 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm diameter. This document does not address particles larger than 10 µm diameter. These particles are deposited in the nasal cavity. Additional information can be needed for medical devices or accessories that bypass the nose. This is outside the scope of this document but can be required by some authorities having jurisdiction. This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry. This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient. This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing. This document does not address biological evaluation of the particles that are deliberately released by a nebulizer (i.e. the therapeutic agent). This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories, containing gas pathways that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 (all parts).
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This document applies to the basic safety and essential performance of a critical care ventilator in
combination with its accessories, hereafter referred to as ME equipment:
intended for use in an environment that provides specialized care for patients whose conditions can
be life-threatening and who can require comprehensive care and constant monitoring in a
professional healthcare facility;
NOTE 2 For the purposes of this document, such an environment is referred to as a critical care
environment. Ventilators for this environment are considered life-sustaining.
NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during
transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not
considered as an emergency medical services environment ventilator.
intended to be operated by a healthcare professional operator; and
intended for those patients who need differing levels of support from artificial ventilation including
for ventilator-dependent patients.
A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a
physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to
a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect
the basic safety or essential performance of the ventilator.NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems
only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause
applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the
scope of this document are not covered by specific requirements in this document except in IEC 60601-
1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to ME equipment or an ME system operating in a ventilator-operational
mode solely intended for patients who are not dependent on artificial ventilation.
NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered lifesustaining.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of
spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13;
ventilators or accessories intended for the emergency medical services environment, which are given
in ISO 80601-2-84;
ventilators or accessories intended for ventilator-dependent patients in the home healthcare
environment, which are given in ISO 80601-2-72;
ventilators or accessories intended for home-care ventilatory support devices, which are given in
ISO 80601-2-79 and ISO 80601-2-80;
obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;
continuous positive airway pressure (CPAP) ME equipment.
high-frequency ventilators, which are given in ISO 80601-2-87;
NOTE 9 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory
ventilator-operational modes.
respiratory high-flow therapy equipment, which are given in ISO 80601-2-90;
NOTE 10 A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is
only for spontaneously breathing
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This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
– intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
– intended to be operated by a healthcare professional operator;
– intended for use in the EMS environment; and
– intended for invasive or non-invasive ventilation.
NOTE 1 An EMS ventilator can also be used for transport within a professional healthcare facility.
* An EMS ventilator is not considered to utilize physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 2 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
This document does not specify the requirements for the following:
– ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
– ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72[3].
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‐2‐13[4].
– ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79[5] and ISO 80601-2-80[6] 1.
– obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70[7].
– operator-powered resuscitators, which are given in ISO 10651‐4[8].
– gas-powered emergency resuscitators, which are given in ISO 10651‐5[9].
– continuous positive airway pressure (CPAP) ME equipment .
– high‐frequency jet ventilators (HFJVs), which are given ISO 80601-2-87[11].
– high‐frequency oscillatory ventilators (HFOVs)[10], which are given ISO 80601-2-87[11].
– NOTE 4 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
– cuirass or “iron‐lung” ventilators.
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This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
¾ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
¾ intended to be operated by a healthcare professional operator;
¾ intended for use in the EMS environment; and
¾ intended for invasive or non-invasive ventilation.
NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.
An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for the following:
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
¾ ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72.
¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
¾ ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80.
¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70.
¾ user-powered resuscitators, which are given in ISO 10651‐4.
¾ gas-powered emergency resuscitators, which are given in ISO 10651‐5.
¾ continuous positive airway pressure (CPAP) ME equipment.
¾ high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87.
¾ high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87.
NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
¾ respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.
NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
¾ oxygen therapy constant flow ME equipment.
¾ cuirass or “iron‐lung” ventilators.
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This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment:
¾ intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
¾ intended to be operated by a healthcare professional operator; and
¾ intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.
NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
¾ ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84;
¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72;
¾ ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80;
¾ obstructive sleep a
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IEC 60601-2-20:2020 is available as IEC 60601-2-20:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-2-20:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.208, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-20:2020 specifies safety requirements for INFANT TRANSPORT INCUBATORS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
- INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50.
IEC 60601-2-20:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision.
IEC 60601-2-20:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
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IEC 60601-2-19:2020 is available as IEC 60601-2-19:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-2-19:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-19:2020 specifies safety requirements for INFANT INCUBATORS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
IEC 60601-2-19:2020 does not apply to:
- INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
- INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-19:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-19:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
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This document provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to provide a distinct respiratory pathway to the top of the larynx to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation. This document specifies the dimensions, basic properties and method of size designation of the available types of supralaryngeal airways. Airways devised for specialized applications are not specifically covered, although most may be classified by the sizing and dimensions (or other characteristics) required by this document. The following devices are outside the scope of this document: nasal and oropharyngeal airways, anesthetic masks, oro- and naso-tracheal tubes, cricothyrotomy devices, dental appliances, tracheal stents, tracheal tubes, ventilating laryngoscopes, CPAP devices, esophageal obturators, bougies and devices that require surgical placement. This document specifies dimensional disclosure so the operator will know which auxiliary devices, such as tracheal tubes and bronchoscopes will be size-compatible. Flammability of airways, for example if used with certain flammable anesthetic gases, electrosurgical units or lasers, is a well-recognized hazard that is outside the scope of this document. (See E.1.7).
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IEC 60601-2-21:2020 is available as IEC 60601-2-21:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-2-21:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-21:2020 specifies the safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
- INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
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This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment: ¾ intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. ¾ intended to be operated by a healthcare professional operator; and ¾ intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13; ¾ ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84; ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72; ¾ ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80; ¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70; ¾ continuous positive airway pressure (CPAP) ME equipment. ¾ high-frequency ventilators, which are given in ISO 80601‑2‑87; NOTE 9 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes. ¾ respiratory high-flow therapy equipment, which are given in ISO 80601‑2‑90; NOTE 10 A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing p
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This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: ¾ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; ¾ intended to be operated by a healthcare professional operator; ¾ intended for use in the EMS environment; and ¾ intended for invasive or non-invasive ventilation. NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility. An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator. NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for the following: NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12. ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13. ¾ ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80. ¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70. ¾ user-powered resuscitators, which are given in ISO 10651‐4. ¾ gas-powered emergency resuscitators, which are given in ISO 10651‐5. ¾ continuous positive airway pressure (CPAP) ME equipment. ¾ high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87. ¾ high‐frequency oscillatory ventilators (HFOVs) REF _Ref69393406 \r \h \* MERGEFORMAT [44] 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000D0000005F00520065006600360039003300390033003400300036000000 , which are given in ISO 80601-2-87. NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes. ¾ respiratory high-flow therapy equipment, which are given in ISO 80601-2-90. NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. ¾ oxygen therapy constant flow ME equipment. ¾ cuirass or “iron‐lung” ventilators.
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ISO 80601-2-12:2023 This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment:
- intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
- intended to be operated by a healthcare professional operator; and
- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.
NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84;
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72;
- ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80;
- obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
- continuous positive airway pressure (CPAP) ME equipment.
- high-frequency ventilators, which are given in ISO 80601‑2‑87;
NOTE 9 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes.
- respiratory high-flow therapy equipment, which are given in ISO 80601‑2‑90;
NOTE 10 A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathin
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ISO 80601-2-84:2023 This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
- intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
- intended to be operated by a healthcare professional operator;
- intended for use in the EMS environment; and
- intended for invasive or non-invasive ventilation.
NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.
An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for the following:
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
- ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72.
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
- ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80.
- obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70.
- user-powered resuscitators, which are given in ISO 10651‐4.
- gas-powered emergency resuscitators, which are given in ISO 10651‐5.
- continuous positive airway pressure (CPAP) ME equipment.
- high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87.
- high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87.
NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
- respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.
NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
- oxygen therapy constant flow ME equipment.
- cuirass or “iron‐lung” ventilators.
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This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.
This document includes gas-powered nebulizers (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and electrically powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers. This document does not specify the electrical requirements of electrically powered nebulizers.
This document does not specify the minimum performance of nebulizing systems.
This document does not apply to:
a) devices intended for nasal deposition;
b) devices intended solely to provide humidification or hydration by providing water in aerosol form.
NOTE 1 ISO 80601-2-74 and ISO 20789 cover these devices.
c) drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).
NOTE 2 ISO 20072 covers these devices.
NOTE 3 See Annex A for rationale.
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This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.
This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
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ISO 80601-2-72:2015 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment:
intended for use in the home healthcare environment;
intended for use by a lay operator;
intended for use with patients who are dependent on mechanical ventilation for their life support.
ISO 80601-2-72:2015 is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
ISO 80601-2-72:2015 is a particular International Standard in the IEC 60601‑1 and ISO/IEC 80601 series of standards.
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This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to: a) a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016; b) the pressure outlet of a regulator conforming with ISO 10524-1:2018; or c) to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets). This document applies to the following types of flow control devices (FCDs): a) flowmeters; b) flowgauge FCDs; and c) fixed orifice FCDs. NOTE Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1. This document applies to flow control devices for the following gases: — oxygen; — oxygen 93 %; — nitrous oxide; — medical air; — carbon dioxide; — oxygen/nitrous oxide mixture 50/50 (% volume fraction); — oxygen-enriched air; — helium; — xenon; and — specified mixtures of the gases listed above. NOTE Flow control devices can be available for other gases. This document does not apply to flow control devices that are: a) for use with gases for driving surgical tools; b) an integral part of a regulator (see ISO 10524-1:2018); or c) an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).
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This document is applicable to pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar or test pressure up to a maximum of 300 bar, or both.
NOTE 1 This type of connection is primarily used for small cylinders (5 l or below).
NOTE 2 In this document the unit bar is used, due to its universal use in the field of technical gases. It should, however, be noted that bar is not an SI unit, and that the corresponding SI unit for pressure is Pa (1 bar = 105 Pa = 105 N/m2).
This document specifies:
— basic dimensions;
— requirements for alternative designs of the yoke-type valve connections;
— dimensions and positions for the holes and pins for the outlet connections.
It also specifies the dimensions and positions for the holes and pins for the outlet connections for gases and gas mixtures.
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This document is applicable to pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar or test pressure up to a maximum of 300 bar, or both.
NOTE 1 This type of connection is primarily used for small cylinders (5 l or below).
NOTE 2 In this document the unit bar is used, due to its universal use in the field of technical gases. It should, however, be noted that bar is not an SI unit, and that the corresponding SI unit for pressure is Pa (1 bar = 105 Pa = 105 N/m2).
This document specifies:
— basic dimensions;
— requirements for alternative designs of the yoke-type valve connections;
— dimensions and positions for the holes and pins for the outlet connections.
It also specifies the dimensions and positions for the holes and pins for the outlet connections for gases and gas mixtures.
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This document is applicable to pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar or test pressure up to a maximum of 300 bar, or both. NOTE 1 This type of connection is primarily used for small cylinders (5 l or below). NOTE 2 In this document the unit bar is used, due to its universal use in the field of technical gases. It should, however, be noted that bar is not an SI unit, and that the corresponding SI unit for pressure is Pa (1 bar = 105 Pa = 105 N/m2). This document specifies: — basic dimensions; — requirements for alternative designs of the yoke-type valve connections; — dimensions and positions for the holes and pins for the outlet connections. It also specifies the dimensions and positions for the holes and pins for the outlet connections for gases and gas mixtures.
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