Lung ventilators - Part 1: Particular requirements for critical care ventilators

To amend EN 794-1 so as to include requirements for use with nitric oxide/ nitrogen mixtures

Lungenbeatmungsgeräte - Teil 1: Besondere Anforderungen an Beatmungsgeräte für die Intensivpflege

Ventilateurs pulmonaires - Partie 1: Règles particulières des ventilateurs pour soins critiques

Pljučni ventilatorji - 1. del: Posebne zahteve za ventilatorje za intenzivno nego

General Information

Status: Withdrawn
Publication Date: 21-Nov-2000
Withdrawal Date: 31-Mar-2009

ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment

Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators

Current Stage: 9960 - Withdrawal effective - Withdrawal
Start Date: 01-Apr-2009
Completion Date: 01-Apr-2009

Directive: 93/42/EEC - Medical devices

Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices

Ref Project: SIST EN 794-1:2000/A1:2001 - Lung ventilators - Part 1: Particular requirements for critical care ventilators

Relations

Merged Into: EN 794-1:1997+A2:2009 - Lung ventilators - Part 1: Particular requirements for critical care ventilators
Effective Date: 18-Jan-2023

Amends: EN 794-1:1997 - Lung ventilators - Part 1: Particular requirements for critical care ventilators
Effective Date: 22-Dec-2008

Amendment

EN 794-1:2000/A1:2001

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Frequently Asked Questions

What is EN 794-1:1997/A1:2000?

EN 794-1:1997/A1:2000 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Lung ventilators - Part 1: Particular requirements for critical care ventilators". This standard covers: To amend EN 794-1 so as to include requirements for use with nitric oxide/ nitrogen mixtures

What is the scope of EN 794-1:1997/A1:2000?

To amend EN 794-1 so as to include requirements for use with nitric oxide/ nitrogen mixtures

What ICS categories does EN 794-1:1997/A1:2000 belong to?

EN 794-1:1997/A1:2000 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

What standards are related to EN 794-1:1997/A1:2000?

EN 794-1:1997/A1:2000 has the following relationships with other standards: It is inter standard links to EN 794-1:1997+A2:2009, EN 794-1:1997. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

Is EN 794-1:1997/A1:2000 a harmonized European standard?

EN 794-1:1997/A1:2000 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

How can I access EN 794-1:1997/A1:2000?

EN 794-1:1997/A1:2000 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)

EN 794-1:2000/A1:2001

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Lung ventilators - Part 1: Particular requirements for critical care ventilators
Lungenbeatmungsgeräte - Teil 1: Besondere Anforderungen an Beatmungsgeräte für die
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Ventilateurs pulmonaires - Partie 1: Regles particulieres des ventilateu
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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.

Standard
44 pages
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09-Dec-2025
11.040.10
CEN/TC 215

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.

Standard
89 pages
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02-Dec-2025
11.040.10
CEN/TC 215

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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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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22 pages
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05-Aug-2025
11.040.10
CEN/TC 215

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.

Standard
36 pages
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22-Jul-2025
11.040.10
CEN/TC 215

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

Amendment
8 pages
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17-Jun-2025
11.040.10
CEN/TC 215

CEN

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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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 18562-1:2024(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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Lung ventilators - Part 1: Particular requirements for critical care ventilators

Lungenbeatmungsgeräte - Teil 1: Besondere Anforderungen an Beatmungsgeräte für die Intensivpflege

Ventilateurs pulmonaires - Partie 1: Règles particulières des ventilateurs pour soins critiques

Pljučni ventilatorji - 1. del: Posebne zahteve za ventilatorje za intenzivno nego

General Information

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EN 794-1:2000/A1:2001

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