EN 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 (ISO 80601-2-84:2023)
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:
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.
Medizinische elektrische Geräte - Teil 2-84: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Notfall- und Transportbeatmungsgeräten (ISO 80601-2-84:2023)
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Abschnitt 1 gilt mit der folgenden Ausnahme:
201.1.1 Anwendungsbereich
Ersatz:
ANMERKUNG 1 Abschnitt AA.2 enthält eine Anleitung und Begründung für diesen Unterabschnitt.
Dieses Dokument gilt für die Basissicherheit und die wesentlichen Leistungsmerkmale eines EMS-Beatmungsgeräts in Kombination mit seinem Zubehör, im Folgenden auch als ME-Gerät bezeichnet:
— bestimmt für Patienten, die in unterschiedlichem Maße Unterstützung durch künstliche Beatmung benötigen, einschließlich beatmungsabhängiger Patienten;
— bestimmt für die Bedienung durch einen medizinisch ausgebildeten Bediener;
— vorgesehen für die Anwendung in der EMS-Umgebung; und
— bestimmt für die invasive oder nicht-invasive Beatmung.
ANMERKUNG 2 Ein EMS-Beatmungsgerät kann auch für den Transport innerhalb einer professionellen Gesundheitseinrichtung verwendet werden.
Bei einem EMS-Beatmungsgerät wird nicht davon ausgegangen, dass es ein physiologisches geschlossenes Regelsystem verwendet, es sei denn, es verwendet eine physiologische Patientenvariable, um die Therapieeinstellungen der künstlichen Beatmung anzupassen.
Dieses Dokument gilt auch für Zubehör, für das der Hersteller den Anschluss an ein Atemsystem des Beatmungsgeräts oder an ein EMS-Beatmungsgerät vorsieht, bei dem die Merkmale dieses Zubehörs die Basissicherheit und die wesentlichen Leistungsmerkmale des EMS-Beatmungsgeräts beeinflussen können.
ANMERKUNG 3 Ist ein Abschnitt oder Unterabschnitt speziell für die Anwendung nur auf ME-Geräten oder nur auf ME-Systemen vorgesehen, ist dies aus Überschrift und Inhalt des Abschnitts oder Unterabschnitts ersichtlich. Ist dies nicht der Fall, gilt der Abschnitt oder Unterabschnitt, je nach Zutreffen, für das ME-Gerät und das ME-System.
Gefährdungen, die der vorgesehenen physiologischen Funktion der in den Anwendungsbereich dieses Dokuments fallenden ME‑Geräte oder ME‑Systeme inhärent sind, werden nicht durch die spezifischen Anforderungen dieses Dokuments abgedeckt, ausgenommen sind IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 und 8.4.1.
[...]
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 :
¾ destinés aux patients ayant besoin de différents niveaux d'assistance par ventilation artificielle, y compris aux patients ventilo-dépendants ;
¾ destinés à être utilisés par un opérateur professionnel de soins de santé ;
¾ destinés à être utilisés dans l'environnement SMU ; et
¾ 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.
¾ 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 ;
¾ 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 ;
¾ ventilateurs ou accessoires prévus pour les applications en anesthésie. Celles-ci sont données dans l'ISO 80601‑2‑13 ;
¾ 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 ;
¾ appareils EM de traitement de l'apnée du sommeil. Celles-ci sont données dans l'ISO 80601‐2‐70 ;
¾ ressuscitateurs à puissance motrice manuelle. Celles-ci sont données dans l'ISO 10651‐4 ;
¾ ressuscitateurs d'urgence alimentés par gaz. Celles-ci sont données dans l'ISO 10651‐5 ;
¾ appareils EM à pression positive continue des voies aériennes (PPC) ;
¾ ventilateurs de jet haute fréquence (VJHF). Celles-ci sont données dans l'ISO 80601-2-87 ;
¾ 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
Medicinska električna oprema - 2-84. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ventilatorjev v okolju nujne medicinske pomoči (ISO 80601-2-84:2023)
Ta dokument se uporablja za osnovno varnost in bistvene lastnosti ventilatorjev v okolju nujne medicinske pomoči v kombinaciji z dodatno opremo, v nadaljevanju: elektromedicinska oprema:
– namenjene pacientom, ki potrebujejo različne stopnje podpore z umetnim dihanjem, vključno z od aparata odvisnimi pacienti;
– namenjene upravljanju, ki ga izvaja zdravstveni delavec operater;
– namenjene za uporabo v okolju nujne medicinske pomoči; in
– namenjene za invazivno in neinvazivno predihavanje.
OPOMBA 1: Ventilator v okolju nujne medicinske pomoči se lahko uporablja za prevoz znotraj strokovne zdravstvene ustanove.
* Ventilator v okolju nujne medicinske pomoči ni namenjen uporabi v fiziološkem sistemu z zaprtozančnim krmiljenjem, razen če uporablja fiziološko spremenljivko pacienta za prilagajanja nastavitev zdravljenja s predihavanjem.
Ta dokument se uporablja tudi za tisto dodatno opremo, ki jo je proizvajalec predvidel za priklop na ventilatorski dihalni sistem ali ventilator v okolju nujne medicinske pomoči, pri čemer lahko lastnosti te dodatne opreme vplivajo na osnovno varnost ali bistvene lastnosti ventilatorja v okolju nujne medicinske pomoči.
OPOMBA 2: Če je točka ali podtočka namenjena samo obravnavi elektromedicinske opreme ali elektromedicinskih sistemov, bo to zapisano v naslovu in vsebini dane točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava elektromedicinsko opremo in elektromedicinske sisteme.
Posebne zahteve tega dokumenta ne vključujejo temeljnih tveganj pri predvideni fiziološki funkciji elektromedicinske opreme ali elektromedicinskih sistemov, ki spadajo na področje uporabe tega dokumenta, razen v točkah 7.2.13 in 8.4.1 standarda IEC 60601‑1:2005.
OPOMBA 3: Dodatne informacije so navedene v točki 4.2 standarda IEC 60601-1:2005+AMD1:2012.
Ta dokument ne določa zahtev za:
– ventilatorje ali dodatno opremo za od aparata odvisne bolnike za uporabo pri intenzivni negi, ki so podani v standardu ISO 80601‑2‑12.
– ventilatorje ali dodatno opremo za uporabo pri od aparata odvisnih bolnikih v okolju domače zdravstvene oskrbe, ki so podani v standardu ISO 80601‑2‑ 72[3].
– ventilatorje ali dodatno opremo za anestezijsko uporabo, ki so podani v standardu ISO 80601‑2‑13[4].
– ventilatorje ali dodatno opremo za podporno ventilatorsko opremo (namenjeno samo za izboljšanje predihavanja pacientov, ki dihajo spontano, ki so podani v standardu ISO 80601-2-79[5] in ISO 80601-2-80[6] 1.
– elektromedicinsko opremo za zdravljenje sindroma obstruktivne apneje v spanju, ki je podana v standardu ISO 80601‐2‐70[7].
– naprave za oživljanje v sili, ki jih upravlja operater, ki so navedene v standardu ISO 10651‐4[8].
– naprave za oživljanje v sili na plin, ki so navedene v standardu ISO 10651‐5[9].
– elektromedicinsko opremo za vzdrževanje stalnega tlaka v dihalnih poteh (CPAP).
– ventilatorje za visokofrekvenčno pospešeno predihavanje (HFJV), ki so navedeni v standardu ISO 80601-2-87[11].
– ventilatorje za visokofrekvenčno oscilacijsko predihavanje (HFOV)[10], ki so navedeni v standardu ISO 80601-2-87[11].
– OPOMBA 4: Ventilator v okolju nujne medicinske pomoči lahko vključuje načina z visokofrekvenčnim pospešenim predihavanjem ali visokofrekvenčnim oscilacijskim predihavanjem.
– ventilatorje t.i. »curiass« ali »železna pljuča«.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN 794-3:2000+A2:2009
Medicinska električna oprema - 2-84. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ventilatorjev v okolju nujne medicinske pomoči (ISO 80601-2-
84:2023)
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)
Medizinische elektrische Geräte - Teil 2-84: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Notfall- und
Transportbeatmungsgeräten (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 (ISO 80601-2-84:2023)
Ta slovenski standard je istoveten z: EN ISO 80601-2-84:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.160 Prva pomoč First aid
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 80601-2-84
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 794-3:1998+A2:2009
English Version
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)
Appareils électromédicaux - Partie 2-84: Exigences Medizinische elektrische Geräte - Teil 2-84: Besondere
particulières relatives à la sécurité de base et aux Festlegungen für die Sicherheit einschließlich der
performances essentielles des ventilateurs utilisés wesentlichen Leistungsmerkmale von Notfall- und
dans l'environnement des services médicaux d'urgence Transportbeatmungsgeräten (ISO 80601-2-84:2023)
(ISO 80601-2-84:2023)
This European Standard was approved by CEN on 1 September 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-84:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-84:2023) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2024, and conflicting national standards shall be
withdrawn at the latest by May 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 794-3:1998+A2:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-84:2023 has been approved by CEN as EN ISO 80601-2-84:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-84
Second edition
2023-11
Medical electrical equipment —
Part 2-84:
Particular requirements for the basic
safety and essential performance of
ventilators for the emergency medical
services environment
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
Reference number
ISO 80601-2-84:2023(E)
ISO 80601-2-84:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
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ISO copyright office
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Published in Switzerland
ii
ISO 80601-2-84:2023(E)
Contents
Foreword . vi
Introduction . viii
201. 1 Scope, object and related standards . 1
201. 1.1 Scope . 1
201. 1.2 Object . 2
201. 1.3 Collateral standards . 2
201. 1.4 Particular standards . 3
201. 2 Normative references . 4
201. 3 Terms and definitions . 5
201. 4 General requirements . 23
201. 4.3 Essential performance . 23
201. 4.3.101 Additional requirements for essential performance . 23
201. 4.3.102 System recovery . 23
201. 4.4 Additional requirements for expected service life . 24
201. 4.5 Alternative risk control measures or test methods for
ME equipment or ME system . 25
201. 4.6 ME equipment or ME system parts that contact the patient . 25
201. 4.11.101 Additional requirements for pressurized gas input . 25
201. 4.11.101.1 Overpressure requirement . 25
201. 4.11.101.2 Compatibility requirement for medical gas pipeline systems . 25
201. 4.11.101.3 Compatibility requirements for pressure regulators . 26
201. 5 General requirements for testing of ME equipment . 26
201. 5.101 Additional requirements for general requirements for testing
of ME equipment . 27
201. 5.101.1 EMS ventilator test conditions 27
201. 5.101.2 Gas flowrate and leakage specifications . 27
201. 5.101.3 EMS ventilator testing errors . 27
201. 6 Classification of ME equipment and ME systems . 27
201. 7 ME equipment identification, marking and documents . 28
201. 7.1.101 Information to be supplied by the manufacturer . 28
201. 7.2.3 Consult accompanying documents . 28
201. 7.2.4.101 Additional requirements for accessories . 28
201. 7.2.18 External gas source . 28
201. 7.2.101 Additional requirements for marking on the outside of
ME equipment or ME equipment parts . 29
201. 7.4.2 Control devices . 30
201. 7.4.3 Units of measurement . 30
201. 7.4.101 Labelling of units of measurement . 30
201. 7.9.2.1 General . 30
201. 7.9.2.1.101 Additional general requirements . 30
201. 7.9.2.2.101 Additional requirements for warnings and safety notices . 30
201. 7.9.2.8.101 Additional requirements for start-up procedure . 31
201. 7.9.2.9.101 Additional requirements for operating instructions . 32
201. 7.9.2.12 Cleaning, disinfection, and sterilization . 33
201. 7.9.2.14.101 Additional requirements for accessories, supplementary
equipment, used material . 33
201. 7.9.3.1.101 Additional general requirements . 33
201. 7.9.3.101 Additional requirements for the technical description . 34
201. 8 Protection against electrical hazards from ME equipment . 34
201. 9 Protection against mechanical hazards of ME equipment and ME systems . 34
ISO 80601-2-84:2023(E)
201. 9.4.3.101 Additional requirements for instability from unwanted lateral
movement . 34
201. 9.4.4 Grips and other handling devices . 35
201. 9.6.2.1.101 Additional requirements for audible acoustic energy . 35
201. 10 Protection against unwanted and excessive radiation hazards. 36
201. 11 Protection against excessive temperatures and other hazards . 36
201. 11.1.2.2 Applied parts not intended to supply heat to a patient . 37
201. 11.6.6 Cleaning and disinfection of ME equipment or ME system . 37
201. 11.6.7 Sterilization of ME equipment or ME system . 38
201. 11.7 Biocompatibility of ME equipment and ME systems . 38
201. 12 Accuracy of controls and instruments and protection against
hazardous outputs . 38
201. 12.1.101 Volume-control inflation-type . 38
201. 12.1.102 Pressure-control inflation-type . 42
201. 12.1.103 Other inflation-typ
...
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