EN 12181:1998
(Main)Oropharyngeal airways
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- 17-Feb-1998
- 26-Apr-2011
- 11.040.10
- CEN/TC 215
Oropharyngeal airways
This European Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. Metal oropharyngeal airways are excluded from the scope of this European Standard.
Oropharyngealtuben
Diese Europäische Norm legt Maße und Anforderungen für Oropharyngealtuben aus Kunststoff und/oder Gummi, mit oder ohne Verstärkungseinsatz aus Kunststoff oder Metall, fest. Sie gilt nicht für Oropharyngealtuben aus Metall.
Canules oro-pharyngées
La présente norme européenne spécifie les prescriptions relatives aux canules oro-pharyngées en matière plastique et/ou en caoutchouc, notamment celles qui comportent un renfort inséré en matière plastique et/ou en métal. Les canules oro-pharyngéeqs en métal sont exclues du domaine d'application de la présente norme européenne.
Ustnožrelne (orofaringealne) dihalne cevke
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ustnožrelne (orofaringealne) dihalne cevkeOropharyngealtubenCanules oro-pharyngéesOropharyngeal airways11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 12181:1998SIST EN 12181:2000en01-januar-2000S
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This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a) a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b) the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c) to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a) flowmeters;
b) flowgauge FCDs; and
c) fixed orifice FCDs.
NOTE Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
— oxygen;
— oxygen 93 %;
— nitrous oxide;
— medical air;
— carbon dioxide;
— oxygen/nitrous oxide mixture 50/50 (% volume fraction);
— oxygen-enriched air;
— helium;
— xenon; and
— specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a) for use with gases for driving surgical tools;
b) an integral part of a regulator (see ISO 10524-1:2018); or
c) an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).
- Draft28 pagesEnglish languagesale 10% offe-Library read for×1 day
- 26-Mar-2024
- 11.040.10
- CEN/TC 215
- Amendment14 pagesEnglish languagesale 10% offe-Library read for×1 day
- 12-Dec-2023
- 11.040.10
- CEN/TC 215
This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
¾ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
¾ intended to be operated by a healthcare professional operator;
¾ intended for use in the EMS environment; and
¾ intended for invasive or non-invasive ventilation.
NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.
An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for the following:
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
¾ ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72.
¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
¾ ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80.
¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70.
¾ user-powered resuscitators, which are given in ISO 10651‐4.
¾ gas-powered emergency resuscitators, which are given in ISO 10651‐5.
¾ continuous positive airway pressure (CPAP) ME equipment.
¾ high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87.
¾ high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87.
NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
¾ respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.
NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
¾ oxygen therapy constant flow ME equipment.
¾ cuirass or “iron‐lung” ventilators.
- Standard149 pagesEnglish languagesale 10% offe-Library read for×1 day
- 14-Nov-2023
- 11.040.10
- 2017/745
- M/575
- CEN/TC 215
This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment:
¾ intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
¾ intended to be operated by a healthcare professional operator; and
¾ intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.
NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
¾ ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84;
¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72;
¾ ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80;
¾ obstructive sleep a
- Standard168 pagesEnglish languagesale 10% offe-Library read for×1 day
- 14-Nov-2023
- 11.040.10
- 2017/745
- M/571
- M/575
- CEN/TC 215
- Amendment7 pagesEnglish languagesale 10% offe-Library read for×1 day
- 31-Oct-2023
- 11.040.10
- CEN/TC 215
This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.
This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
- Standard35 pagesEnglish languagesale 10% offe-Library read for×1 day
- 25-Jul-2023
- 11.040.10
- CEN/TC 215
This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.
This document includes gas-powered nebulizers (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and electrically powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers. This document does not specify the electrical requirements of electrically powered nebulizers.
This document does not specify the minimum performance of nebulizing systems.
This document does not apply to:
a) devices intended for nasal deposition;
b) devices intended solely to provide humidification or hydration by providing water in aerosol form.
NOTE 1 ISO 80601-2-74 and ISO 20789 cover these devices.
c) drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).
NOTE 2 ISO 20072 covers these devices.
NOTE 3 See Annex A for rationale.
- Standard41 pagesEnglish languagesale 10% offe-Library read for×1 day
- 25-Jul-2023
- 11.040.10
- CEN/TC 215
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
— intended for use in the home healthcare environment;
— intended for use by a lay operator; and
— intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
- Standard152 pagesEnglish languagesale 10% offe-Library read for×1 day
- 11-Jul-2023
- 11.040.10
- CEN/TC 215
This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range.
Example user-powered resuscitators include:
— self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and
NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations.
— flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source.
This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator.
Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.
This document is also applicable to point-of-use packaging.
This document does not specify the requirements for:
— gas-powered emergency resuscitators, which are given in ISO 10651-5;
— electrically-powered resuscitators;
— gas powered resuscitators for professional healthcare facilities; and
— anaesthetic reservoir bags, which are given in ISO 5362.
NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E.
NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.
- Standard76 pagesEnglish languagesale 10% offe-Library read for×1 day
- 04-Apr-2023
- 11.040.10
- 2017/745
- M/575
- CEN/TC 215
This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications.
Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.
NOTE 1 There is guidance or rationale for this clause contained in Annex A.2.
NOTE 2 ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.
- Standard54 pagesEnglish languagesale 10% offe-Library read for×1 day
- 31-Jan-2023
- 11.040.10
- CEN/TC 215
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