EN 737-3:1998/AC:2000
(Corrigendum)Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum
Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum
TC - Mistake in Bild 1, German version
Rohrleitungssysteme für medizinische Gase - Teil 3: Rohrleitungen für medizinische Druckgase und Vakuum
Systèmes de distribution de gaz médicaux -Partie 3: Systèmes de distribution pour gaz médicaux comprimés et vide (aspiration)
Sistemi napeljav za medicinske pline - 3. del: Napeljave za stisnjene medicinske pline in podtlak
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sistemi napeljav za medicinske pline - 3. del: Napeljave za stisnjene medicinske pline in podtlakRohrleitungssysteme für medizinische Gase - Teil 3: Rohrleitungen für medizinische Druckgase und VakuumMedical gas pipeline systems - Part 3: Pipelines for compressed
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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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- 22-Oct-2024
- 11.040.10
- 2017/745
- M/575
- CEN/TC 215
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:
— 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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NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.
— intended for use by a lay operator;
— intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and
— not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD).
Ventilatory support equipment 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 breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
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.
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
This document does not specify the requirements for:
— ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
— 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;
— ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
— sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
— high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
— high-frequency oscillatory ventilators (HFOVs);
— respiratory high flow equipment, which are given in
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NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.
— intended for use by a lay operator;
— intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
— intended for transit-operable use; and
— not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.
Ventilatory support equipment 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 of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
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.
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
This document does not specify the requirements for:
— ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
— 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;
— ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79;
— sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
— high-frequency jet ventilato
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This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.
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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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