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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

Parent
11.040 - Medical equipment

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Standardization Organization
Technical Committee
Directive
Mandate
50
SIST
SIST EN ISO 80601-2-70:2026(Main)
Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2025)
EN ISO 80601-2-70:2025

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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.
NOTE 2        See also 4.2 of the general standard.
This document does not specify the requirements for:
–    ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, 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 home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
–    ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
–    ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
–    high-frequency ventilators[23], which are given in ISO 80601-2-87.
–    respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3      ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
–    user-powered resuscitators, which are given in ISO 10651-4;
–    gas-powered emergency resuscitators, which are given in ISO 10651-5;
–    oxygen therapy constant flow ME equipment; and
–    cuirass or “iron-lung” ventilation equipment.

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CEN
EN ISO 17510:2025(Main)
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2025)
SIST EN ISO 17510:2026

This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
NOTE            This document has been prepared to address the relevant essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.

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SIST
SIST EN ISO 18777-2:2026(Main)
Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units (ISO 18777-2:2025)
EN ISO 18777-2:2025

This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE            Requirements that are common to both portable units and base units are specified in ISO 18777-1.

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CEN
EN ISO 80601-2-70:2025(Main)
Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2025)
SIST EN ISO 80601-2-70:2026

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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.
NOTE 2        See also 4.2 of the general standard.
This document does not specify the requirements for:
–    ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, 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 home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
–    ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
–    ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
–    high-frequency ventilators[23], which are given in ISO 80601-2-87.
–    respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3      ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
–    user-powered resuscitators, which are given in ISO 10651-4;
–    gas-powered emergency resuscitators, which are given in ISO 10651-5;
–    oxygen therapy constant flow ME equipment; and
–    cuirass or “iron-lung” ventilation equipment.

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IEC
ISO 17510:2025(Main)
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories

This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
NOTE This document has been prepared to address the relevant essential principles [14] and labelling principles [15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.

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ISO
ISO 17510:2025(Main)
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear). This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. The requirements in this document take priority over the requirements in ISO 18190. This document does not cover oral appliances. NOTE This document has been prepared to address the relevant essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.

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CEN
EN ISO 18777-2:2025(Main)
Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units (ISO 18777-2:2025)
SIST EN ISO 18777-2:2026

This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE            Requirements that are common to both portable units and base units are specified in ISO 18777-1.

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ISO
ISO 80601-2-70:2025(Main)
Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. 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. NOTE 2 See also 4.2 of the general standard. This document does not specify the requirements for: – ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, 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 home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. – ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84. – ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80. – high-frequency ventilators[23], which are given in ISO 80601-2-87. – respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. – user-powered resuscitators, which are given in ISO 10651-4; – gas-powered emergency resuscitators, which are given in ISO 10651-5; – oxygen therapy constant flow ME equipment; and – cuirass or “iron-lung” ventilation equipment.

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IEC
ISO 80601-2-70:2025(Main)
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

ISO 80601-2-70:2025 This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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.
NOTE 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
– ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, 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 home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.

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ISO
ISO 18777-2:2025(Main)
Transportable liquid oxygen systems for medical use — Part 2: Particular requirements for portable units

This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment. Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector. NOTE Requirements that are common to both portable units and base units are specified in ISO 18777-1.

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ISO
ISO 80369-1:2025(Main)
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements

This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to: — respiratory; — enteral; — limb cuff inflation; — neural; — intravascular or hypodermic; — other use cases utilizing an ISO 80369-7 small-bore connector. This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series. NOTE Clause A.2 contains guidance or rationale for this Clause.

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IEC
ISO 80369-1:2025(Main)
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
- respiratory;
- enteral;
- limb cuff inflation;
- neural;
- intravascular or hypodermic;
- other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE Clause A.2 contains guidance or rationale for this Clause.

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SIST
SIST EN ISO 7376:2020/A1:2025(Amendment)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)
EN ISO 7376:2020/A1:2025
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ISO
ISO 19223-3:2025(Main)
Lung ventilators and related equipment — Vocabulary and semantics — Part 3: Respiratory care

This document defines terms for respiratory care. This document is applicable: — in respiratory high-flow therapy equipment standards; — in sleep apnoea breathing therapy equipment standards; — in sleep apnoea breathing therapy masks and accessories standards; — in ventilatory support equipment standards; — in health informatics standards; — for labelling on medical electrical equipment and medical electrical systems; — in medical electrical equipment and medical electrical system instructions for use and accompanying documents; — for medical electrical equipment and medical electrical systems interoperability; — in electronic health records. This document excludes mechanical ventilation (defined in ISO 19223:2019), high-frequency and jet ventilation (defined in ISO 19223-2:2025), negative pressure ventilation, liquid ventilation, and extracorporeal membrane oxygenation.

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ISO
ISO 7376-2:2025(Main)
Anaesthetic and respiratory equipment — Part 2: Video laryngoscopes

This document specifies requirements for electrically powered video laryngoscopes that comprise a handle, a rigid blade, a light source, a camera and an image display that provides a clear view of the larynx to assist tracheal intubation. This document specifies requirements for accessories that are essential to the function of the video laryngoscope. This document is not applicable to the following: — laryngoscopes without a camera or image display (see ISO 7376); — endoscopes (see ISO 8600-1); — laryngoscopes designed for surgery; — image quality requirement for third party display screens, for example a phone or computer monitor, and which are not supplied by the video laryngoscope manufacturer as part of the video laryngoscope system.

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SIST
SIST EN ISO 19211:2025(Main)
Anaesthetic and respiratory equipment - Fire-activated oxygen shut-off devices for use during oxygen therapy (ISO 19211:2024)
EN ISO 19211:2025

This document specifies requirements for fire activated oxygen shut-off devices that stop the flow of oxygen in respiratory therapy tubing when activated by fire.
NOTE 1        Typical arrangements for fire activated oxygen shut-off devices are shown in Annex C.
NOTE 2        Respiratory therapy tubing is covered by ISO 17256.
NOTE 3        Use of fire activated oxygen shut-off devices in medical devices or accessories is not mandated in this document.
The fire activated oxygen shut-off devices specified in this document are not suitable for use with oxygen therapy systems with flows in excess of 20 l/min).
NOTE 4        There is rationale for this clause in A.2.
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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SIST
SIST EN ISO 7396-3:2025(Main)
Medical gas pipeline systems - Part 3:Proportioning units for the production of synthetic medical air (ISO 7396-3:2025)
EN ISO 7396-3:2025

1.1        This document specifies requirements relating to the construction and operation of devices producing air through the blending of oxygen and nitrogen for use as sources of supply in supply systems for medical gases.
1.2        This document is applicable to proportioning units intended to produce synthetic medical air and air for driving surgical tools by mixing in defined proportions oxygen and nitrogen.
1.3        This document is applicable to proportioning units intended to be components of a medical gas supply system for medical air which supplies a medical gas pipeline distribution system complying with ISO 7396-1.
1.4        The number of proportioning units within the medical air supply system and their combination with other sources of supply (e.g. cylinder manifolds) to ensure that the supply system consists of at least three sources of supply is outside the scope of this document.
Requirements for the supply systems for medical air are given in ISO 7396-1.

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CEN
EN ISO 19211:2025(Main)
Anaesthetic and respiratory equipment - Fire-activated oxygen shut-off devices for use during oxygen therapy (ISO 19211:2024)
SIST EN ISO 19211:2025

This document specifies requirements for fire activated oxygen shut-off devices that stop the flow of oxygen in respiratory therapy tubing when activated by fire.
NOTE 1        Typical arrangements for fire activated oxygen shut-off devices are shown in Annex C.
NOTE 2        Respiratory therapy tubing is covered by ISO 17256.
NOTE 3        Use of fire activated oxygen shut-off devices in medical devices or accessories is not mandated in this document.
The fire activated oxygen shut-off devices specified in this document are not suitable for use with oxygen therapy systems with flows in excess of 20 l/min).
NOTE 4        There is rationale for this clause in A.2.
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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CEN
EN ISO 7396-3:2025(Main)
Medical gas pipeline systems - Part 3:Proportioning units for the production of synthetic medical air (ISO 7396-3:2025)
SIST EN ISO 7396-3:2025

1.1        This document specifies requirements relating to the construction and operation of devices producing air through the blending of oxygen and nitrogen for use as sources of supply in supply systems for medical gases.
1.2        This document is applicable to proportioning units intended to produce synthetic medical air and air for driving surgical tools by mixing in defined proportions oxygen and nitrogen.
1.3        This document is applicable to proportioning units intended to be components of a medical gas supply system for medical air which supplies a medical gas pipeline distribution system complying with ISO 7396-1.
1.4        The number of proportioning units within the medical air supply system and their combination with other sources of supply (e.g. cylinder manifolds) to ensure that the supply system consists of at least three sources of supply is outside the scope of this document.
Requirements for the supply systems for medical air are given in ISO 7396-1.

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ISO
ISO 7396-3:2025(Main)
Medical gas pipeline systems — Part 3: Proportioning units for the production of synthetic medical air

1.1 This document specifies requirements relating to the construction and operation of devices producing air through the blending of oxygen and nitrogen for use as sources of supply in supply systems for medical gases. 1.2 This document is applicable to proportioning units intended to produce synthetic medical air and air for driving surgical tools by mixing in defined proportions oxygen and nitrogen. 1.3 This document is applicable to proportioning units intended to be components of a medical gas supply system for medical air which supplies a medical gas pipeline distribution system complying with ISO 7396-1. 1.4 The number of proportioning units within the medical air supply system and their combination with other sources of supply (e.g. cylinder manifolds) to ensure that the supply system consists of at least three sources of supply is outside the scope of this document. Requirements for the supply systems for medical air are given in ISO 7396-1.

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CEN
EN ISO 7376:2020/A1:2025(Amendment)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)
SIST EN ISO 7376:2020/A1:2025
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ISO
ISO 7376:2020/Amd 1:2025(Amendment)
Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation — Amendment 1: Clarification of optical output and illumination requirements
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ISO
ISO 19223-2:2025(Main)
Lung ventilators and related equipment — Vocabulary and semantics — Part 2: High frequency and jet ventilation

This document defines terms for: — high-frequency oscillatory ventilation (HFOV); — percussive ventilation, including high-frequency percussive ventilation (HFPV); — jet ventilation, including high frequency jet ventilation (HFJV); — modes that combine high-frequency and physiological-rate ventilation. It is applicable: — in lung ventilator and breathing-therapy device standards, — in health informatics standards, — for labelling on medical electrical equipment and medical electrical systems, — in medical electrical equipment and medical electrical system instructions for use and accompanying documents, — for medical electrical equipment and medical electrical systems interoperability, and — in electronic health records. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilatorbreathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator or ventilator breathing system. NOTE This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.

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ISO
ISO 18190:2025(Main)
Anaesthetic and respiratory equipment — General requirements for airway devices and related equipment

This document specifies the general requirements common to airway devices and related equipment.

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SIST
SIST EN ISO 80369-20:2025(Main)
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2024)
EN ISO 80369-20:2024

NOTE            Clause A.2 contains guidance or rationale for this clause.
This document specifies the common test methods to evaluate the performance requirements for small-bore connectors specified in the ISO and IEC 80369 series as well as the ISO 18250 series.

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EN ISO 80369-20:2024(Main)
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369‑20:2024)
SIST EN ISO 80369-20:2025

NOTE            Clause A.2 contains guidance or rationale for this clause.
This document specifies the common test methods to evaluate the performance requirements for small-bore connectors specified in the ISO and IEC 80369 series as well as the ISO 18250 series.

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ISO
ISO 80369-20:2024(Main)
Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods

NOTE Clause A.2 contains guidance or rationale for this clause. This document specifies the common test methods to evaluate the performance requirements for small-bore connectors specified in the ISO and IEC 80369 series as well as the ISO 18250 series.

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SIST EN ISO 18562-1:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)
EN ISO 18562-1:2024

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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SIST EN ISO 18562-3:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
EN ISO 18562-3:2024

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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SIST EN ISO 18562-4:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
EN ISO 18562-4:2024

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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SIST EN ISO 18562-2:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
EN ISO 18562-2:2024

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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EN ISO 18562-1:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)
SIST EN ISO 18562-1:2024

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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EN ISO 18562-3:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
SIST EN ISO 18562-3:2024

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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EN ISO 18562-2:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
SIST EN ISO 18562-2:2024

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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EN ISO 18562-4:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
SIST EN ISO 18562-4:2024

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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SIST EN ISO 80601-2-80:2024(Main)
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024)
EN ISO 80601-2-80:2024

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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SIST EN ISO 80601-2-79:2024(Main)
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2024)
EN ISO 80601-2-79:2024

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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SIST EN ISO 80369-2:2024(Main)
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024)
EN ISO 80369-2:2024

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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CEN
EN ISO 80601-2-79:2024(Main)
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2024)
SIST EN ISO 80601-2-79:2024

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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CEN
EN ISO 80601-2-80:2024(Main)
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024)
SIST EN ISO 80601-2-80:2024

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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ISO
ISO 19211:2024(Main)
Anaesthetic and respiratory equipment — Fire-activated oxygen shut-off devices for use during oxygen therapy

This document specifies requirements for fire activated oxygen shut-off devices that stop the flow of oxygen in respiratory therapy tubing when activated by fire. NOTE 1 Typical arrangements for fire activated oxygen shut-off devices are shown in Annex C. NOTE 2 Respiratory therapy tubing is covered by ISO 17256. NOTE 3 Use of fire activated oxygen shut-off devices in medical devices or accessories is not mandated in this document. The fire activated oxygen shut-off devices specified in this document are not suitable for use with oxygen therapy systems with flows in excess of 20 l/min). NOTE 4 There is rationale for this clause in A.2. 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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IEC
ISO 80601-2-80:2024(Main)
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

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 ventilators (HFJVs), which are given in ISO 80601‑2‑87;
- high-frequency oscillatory ventilators (HFOVs);
- respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
- user-powered resuscitators, which are given in ISO 10651-4;
- gas-powered emergency resuscitators, which are given in ISO 10651-5;
- oxygen therapy constant flow ME equipment; and
- cuirass or “iron-lung” ventilation equipment.

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IEC
ISO 80601-2-79:2024(Main)
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

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 ISO 80601‑2‑90;
NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
- user-powered resuscitators, which are given in ISO 10651-4;
- gas-powered emergency resuscitators, which are given in ISO 10651-5;
- oxygen therapy constant flow ME equipment; and
- cuirass or “iron-lung” ventilation equipment.

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CEN
EN ISO 80369-2:2024(Main)
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06)
SIST EN ISO 80369-2:2024

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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ISO
ISO 80601-2-80:2024(Main)
Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

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 ventilators (HFJVs), which are given in ISO 80601‑2‑87; — high-frequency oscillatory ventilators (HFOVs); — respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. — user-powered resuscitators, which are given in ISO 10651-4; — gas-powered emergency resuscitators, which are given in ISO 10651-5; — oxygen therapy constant flow ME equipment; and — cuirass or “iron-lung” ventilation equipment

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ISO
ISO 80601-2-79:2024(Main)
Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

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 ISO 80601‑2‑90; NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. — user-powered resuscitators, which are given in ISO 10651-4; — gas-powered emergency resuscitators, which are given in ISO 10651-5; — oxygen therapy constant flow ME equipment; and — cuirass or “iron-lung” ventilation equipment.

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SIST
SIST EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
EN ISO 5362:2024

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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CEN
EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
SIST EN ISO 5362:2024

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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ISO
ISO 17256:2024(Main)
Anaesthetic and respiratory equipment — Respiratory therapy tubing and connectors

This document specifies requirements for the respiratory tubing and connectors used to convey respirable gases to a patient in the healthcare and homecare environments and provide a safe connection between the gas supply device and the patient interface. Respiratory tubing and connectors are mainly used for delivery of oxygen but can also be used for respirable air or oxygen/air mixtures and breathable medicinal gas mixtures such as oxygen/nitrous oxide or oxygen/helium mixtures. This document also specifies requirements for respiratory therapy extension tubing. NOTE 1 The gas supply devices referred to in this document do not include anaesthetic machines/workstations and ventilators. NOTE 2 This document does not cover breathing tubes for breathing systems. These are specified in ISO 5367. This document is written following the format of ISO 18190, General standard for airways and related equipment. The requirements in this device-specific standard take precedence over any conflicting requirements in the General standard

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ISO
ISO 5362:2024(Main)
Anaesthetic and respiratory equipment – Anaesthetic reservoir bags

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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