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ISO 80601-2-84:2023

(Main)

Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

ISO 80601-2-84:2023 This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
- intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
- intended to be operated by a healthcare professional operator;
- intended for use in the EMS environment; and
- intended for invasive or non-invasive ventilation.
NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.
An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for the following:
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
- ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72.
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
- ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80.
- obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70.
- user-powered resuscitators, which are given in ISO 10651‐4.
- gas-powered emergency resuscitators, which are given in ISO 10651‐5.
- continuous positive airway pressure (CPAP) ME equipment.
- high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87.
- high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87.
NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
- respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.
NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
- oxygen therapy constant flow ME equipment.
- cuirass or “iron‐lung” ventilators.

Appareils électromédicaux - Partie 2-84: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs utilisés dans l'environnement des services médicaux d'urgence

ISO 80601-2-84:2023 Le présent document s'applique à la sécurité de base et aux performances essentielles d'un ventilateur SMU associé à ses accessoires, appelés ci-après appareil EM :
- destinés aux patients ayant besoin de différents niveaux d'assistance par ventilation artificielle, y compris aux patients ventilo-dépendants ;
- destinés à être utilisés par un opérateur professionnel de soins de santé ;
- destinés à être utilisés dans l'environnement SMU ; et
- destinés à la ventilation invasive ou non invasive.
NOTE 2 Un ventilateur SMU peut également être utilisé lors d'un transport dans un établissement de soins professionnel.
Un ventilateur SMU n'est pas censé utiliser un système physiologique de commande en boucle fermée, sauf s'il utilise une variable physiologique du patient pour ajuster les paramètres de thérapie par ventilation artificielle.
Le présent document s'applique également aux accessoires conçus par leur fabricant pour être connectés au système respiratoire du ventilateur, ou à un ventilateur SMU, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base et les performances essentielles du ventilateur SMU.
NOTE 3 Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Dans le cas contraire, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de l'IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 et 8.4.1.
NOTE 4 Des informations supplémentaires peuvent être trouvées dans l'IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2
Le présent document ne spécifie pas les exigences applicables aux :
NOTE 5 Voir l'ISO/TR 21954 pour des recommandations relatives à la sélection du ventilateur approprié pour un patient donné.
- ventilateurs ou accessoires prévus pour les patients ventilo-dépendants dans les applications de soins intensifs. Celles-ci sont données dans l'ISO 80601-2-12 ;
- ventilateurs ou accessoires prévus pour les patients ventilo-dépendants dans l'environnement des soins à domicile. Celles-ci sont données dans l'ISO 80601-2-72 ;
- ventilateurs ou accessoires prévus pour les applications en anesthésie. Celles-ci sont données dans l'ISO 80601‑2‑13 ;
- ventilateurs ou accessoires prévus pour les équipements d'assistance respiratoire (uniquement destinés à augmenter la ventilation des patients qui respirent spontanément). Celles-ci sont données dans l'ISO 80601‑2‑79 et l'ISO 80601‑2‑80 ;
- appareils EM de traitement de l'apnée du sommeil. Celles-ci sont données dans l'ISO 80601‐2‐70 ;
- ressuscitateurs à puissance motrice manuelle. Celles-ci sont données dans l'ISO 10651‐4 ;
- ressuscitateurs d'urgence alimentés par gaz. Celles-ci sont données dans l'ISO 10651‐5 ;
- appareils EM à pression positive continue des voies aériennes (PPC) ;
- ventilateurs de jet haute fréquence (VJHF). Celles-ci sont données dans l'ISO 80601-2-87 ;
- ventilateurs à oscillation haute fréquence (VOHF)[44]. Celles-ci sont données dans l'ISO 80601-2-87 ;
NOTE 6 Un ventilateur SMU peut incorporer des modes de ventilation à jet haute fréquence ou à oscillation haute fréquence.
- équipements de thérapie respiratoire à haut débit. Celles-ci sont données dans l'ISO 80601-2-90 ;
NOTE 7 Un ventilateur SMU peut intégrer un mode de fonctionnement de thérapie à haut débit, mais ce mode est réservé aux patients qui respirent spontanément.
- appareils EM délivrant un débit constant d'oxygénothérapie ;
- cuirasses ou « poumons d'acier ».

General Information

Status
Published
Publication Date
02-Nov-2023
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
SC 62D - Particular medical equipment, software, and systems
Drafting Committee
JWG 1 - TC 62/SC 62D/JWG 1
Current Stage
APUB - Draft approved for publication
Start Date
04-Aug-2023
Completion Date
25-Aug-2023
Ref Project

Relations

Revises
ISO 80601-2-84:2020 - Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
Effective Date
05-Sep-2023

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ISO 80601-2-84:2023 - Appareils électromédicaux - Partie 2-84: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs utilisés dans l'environnement des services médicaux d'urgenceISO 80601-2-84:2023 - Appareils électromédicaux - Partie 2-84: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs utilisés dans l'environnement des services médicaux d'urgence
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ISO 80601-2-84:2023 - Appareils électromédicaux - Partie 2-84: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs utilisés dans l'environnement des services médicaux d'urgence
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NORME ISO 80601
INTERNATIONALE -2-84
Deuxième édition
2023-11
Appareils électromédicaux —
Partie 2-84:
Exigences particulières relatives à la
sécurité de base et aux performances
essentielles des ventilateurs utilisés
dans l'environnement des services
médicaux d'urgence
Medical electrical equipment —
Part 2-84: Particular requirements for the basic safety and essential
performance of ventilators for the emergency medical services
environment
Numéro de référence
ISO 80601-2-84:2023(F)
© ISO 2023

---------------------- Page: 1 ----------------------
ISO 80601-2-84:2023(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2023
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii
  © ISO 2023 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 80601-2-84:2023(F)
Sommaire Page
Avant-propos . vii
Introduction . ix
201. 1 Domaine d'application, objet et normes connexes . 1
201. 1.1 Domaine d'application . 1
201. 1.2 Objet . 2
201. 1.3 Normes collatérales . 3
201. 1.4 Normes particulières . 3
201. 2 Références normatives . 4
201. 3 Termes et définitions . 5
201. 4 Exigences générales . 24
201. 4.3 Performance essentielle . 24
201. 4.3.101 Exigences supplémentaires relatives aux performances
essentielles . 24
201. 4.3.102 Récupération du système . 25
201. 4.4 Exigences supplémentaires relatives à la durée de vie prévue . 26
201. 4.5 Mesures de maîtrise du risque ou méthodes d'essai
alternatives pour les appareils EM ou les systèmes EM . 26
201. 4.6 Parties d'appareil EM ou de système EM en contact avec le
patient . 26
201. 4.11.101 Exigences supplémentaires pour l'entrée de gaz sous pression . 27
201. 4.11.101.1 Exigences relatives à la surpression . 27
201. 4.11.101.2 Exigences de compatibilité relatives aux systèmesde
distributionde gaz médicaux . 27
201. 4.11.101.3 Exigences de compatibilité relatives aux régulateurs de pression . 28
201. 5 Exigences générales relatives aux essais des appareils EM . 28
201. 5.101 Exigences supplémentaires pour les exigences générales d'essai
d'un appareil EM . 28
201. 5.101.1 Conditions d'essai du ventilateur SMU . 28
201. 5.101.2 Spécifications des débits de gaz et des fuites . 29
201. 5.101.3 Erreurs d'essai du ventilateur SMU . 29
201. 6 Classification des appareils EM et des systèmes EM . 29
201. 7 Identification, marquage et documentation des appareils EM . 29
201. 7.1.101 Informations à fournir par le fabricant . 29
201. 7.2.3 Consulta
...

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ISO 80601-2-74:2021(Main)
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.
This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers).
NOTE 1 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601-1.
NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes.
This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.
NOTE 3 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.
EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601-2-12[10] also applies.
EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601-2-72[12] also applies.
EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601-2-70[11] also applies.
EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79[13] or ISO 80601-2-80[14] also apply.
EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601-2-90[15] also applies.
This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.
NOTE 4 ISO 9360-1 and ISO 9360-2[4] specify safety and performance requirements for a passive HME.
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 does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789[6].
This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.
This document is not applicable to nebulizers used for the delivery of a drug to patients.
NOTE 7 ISO 27427[7] specifies the safety and performance requirements for nebulizers.

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ISO 80601-2-87:2021(Main)
Medical electrical equipment - Part 2-87: Particular requirements for the basic safety and essential performance of high frequency ventilators

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment:
- intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator).
NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment.
- intended to be operated by a healthcare professional operator;
- intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and
- capable of providing more than 150 inflations/min.
There are three principal designations of HFV:
- high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min];
- high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and
- high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase].
Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min.
*A high-frequency ventilator is not considered a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator.
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 IEC 60601-1:2005.
NOTE 4 Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012.
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:
- non-high-frequency ventilators or accessories which provide conventional ventilation for use in critical care environments, which are given in ISO 80601-2-12 [23];.
NOTE 5 An HFV can incorporate conventional critical care ventilator operational modes, in which case ISO 80601-2-12 is applicable to those modes.
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13 [24];
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84, the replacement for ISO 10651-3 [13];
NOTE 6 An HFV can incorporate EMS ventilator capability.
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-€‘2-72 [26];
- ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO

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ISO 80601-2-85:2021(Main)
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use.
NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature.
Not included within the scope of this document are:
- invasive tissue or vascular oximeters;
- oximeters that require a blood sample from the patient;
- equipment measuring dissolved oxygen;
- ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71[4];
- ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601‑2‑61[3];
- ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the head.
This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured.
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 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard.
NOTE 2 See also 4.2 of the general standard.
This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury or disability.
This document is not applicable to remote or slave (secondary) equipment that displays StO2 values that are located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.

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