SIST EN ISO 80601-2-12:2024
(Main)Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)
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
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege (ISO 80601-2-12:2023)
Dieses Dokument gilt für die Basissicherheit und die wesentlichen Leistungsmerkmale von Beatmungsgeräten zusammen mit deren Zubehör, deren Kombination nachfolgend als ME Gerät bezeichnet wird und die:
- vorgesehen sind für den Gebrauch in einer Umgebung, die eine spezielle Pflege für Patienten bietet, deren Zustand lebensgefährlich sein kann und die eine umfassende Pflege sowie ununterbrochene Überwachung in einer professionellen Gesundheitseinrichtung erfordern können;
ANMERKUNG 1 Im Sinne dieses Dokuments wird eine derartige Umgebung eine Intensivpflege-Umgebung genannt. Beatmungsgeräte für diese Umgebung werden als lebenserhaltend erachtet.
ANMERKUNG 2 Im Sinne dieses Dokuments kann ein derartiges Beatmungsgerät den Krankentransport innerhalb einer professionellen Gesundheitseinrichtung ermöglichen (d. h. ein Beatmungsgerät sein, das betriebsfähig bei Bewegung ist).
ANMERKUNG 3 Ein Beatmungsgerät für die Intensivpflege, das für den Krankentransport innerhalb einer professionellen Gesundheitseinrichtung vorgesehen ist, wird nicht als ein in einer Umgebung für den Notfalleinsatz verwendetes Beatmungsgerät betrachtet.
- vorgesehen sind für den Betrieb durch einen medizinisch ausgebildeten Bediener; und
- vorgesehen sind für diejenigen Patienten, die unterschiedliche Unterstützungsniveaus der künstlichen Beatmung benötigen, einschließlich der vom Gerät abhängigen Patienten.
Für ein Beatmungsgerät für die Intensivpflege gilt, dass es kein physiologisches geschlossenes Regelsystem nutzt, solange es keine physiologische Patienten-Größe zum Nachregeln der therapeutischen Beatmungs-Einstellungen verwendet.
Dieses Dokument gilt auch für Zubehör, das vom Hersteller für den Anschluss an ein Beatmungsgerät-Atemsystem oder an ein Beatmungsgerät vorgesehenen ist, wenn die Eigenschaften dieses Zubehörs die Basissicherheit und die wesentlichen Leistungsmerkmale des Beatmungsgeräts beeinträchtigen können.
ANMERKUNG 4 Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf ME-Geräte oder nur auf ME-Systeme vorgesehen, ist dies aus Überschrift und Inhalt des Abschnittes oder Unterabschnittes ersichtlich. Ist das nicht der Fall, trifft der Abschnitt oder Unterabschnitt, wo anwendbar, auf das ME-Gerät und das ME-System zu.
Gefährdungen, die sich aus der vorgesehenen physiologischen Wirkungsweise von ME-Geräten oder ME-Systemen im Anwendungsbereich dieses Dokuments ergeben, sind nicht durch besondere Anforderungen in diesem Dokument erfasst, ausgenommen bei IEC 60601 1:2005+AMD2:2020, 7.2.13 und 8.4.1.
ANMERKUNG 5 Weitere Informationen sind in IEC 60601 1:2005+AMD1:2012+AMD2:2020, 4.2 enthalten.
Dieses Dokument gilt nicht für ME-Geräte und ME-Systeme, die in einer Beatmungsgeräte-Betriebsart arbeiten, die ausschließlich für nicht von künstlicher Beatmung abhängige Patienten vorgesehen sind.
ANMERKUNG 6 Ein Intensivpflege-Beatmungsgerät, das in einer solchen Beatmungsgeräte-Betriebsart benutzt wird, wird nicht als lebenserhaltend angesehen.
Dieses Dokument gilt nicht für ME-Geräte, die in einer professionellen Gesundheitseinrichtung ausschließlich zum Verstärken der Beatmung von spontan atmenden Patienten vorgesehen sind.
[...]
Appareils électromédicaux - Partie 2-12: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs (ISO 80601-2-12:2023)
Le présent document s’applique à la sécurité de base et aux performances essentielles d’un ventilateur de soins intensifs associé à ses accessoires, ci-après désignés par appareil EM:
¾ prévu pour une utilisation dans un environnement qui fournit des soins spécialisés aux patients dont l’état de santé peut mettre leur vie en danger et qui peuvent exiger des soins complets et une surveillance constante dans un établissement de soins professionnel;
NOTE 2 Pour les besoins du présent document, un environnement de cette nature est appelé «environnement de soins intensifs». Les ventilateurs pour un tel environnement sont considérés comme étant essentiels aumaintien de la vie.
NOTE 3 Pour les besoins du présent document, un tel ventilateur de soins intensifs peut fournir une ventilation durant le transport à l’intérieur d’un établissement de soins professionnel (c’est-à-dire être un ventilateur opérationnel en déplacement).
NOTE 4 Un ventilateur pour utilisation en soins intensifs destiné à être utilisé durant le transport à l’intérieur d’un établissement de soins professionnel n’est pas considéré comme un ventilateur destiné à être utilisé dans l’environnement des services médicaux d’urgence.
¾ prévu pour être utilisé par un opérateur professionnel de soins de santé; et
¾ prévu pour les patients qui nécessitent différents niveaux d’aide par ventilation artificielle, y compris pour les patients ventilo-dépendants.
Un ventilateur pour utilisation en soins intensifs n’est pas considéré comme utilisant un système physiologique de commande en boucle fermée, à moins qu’il n’utilise une variable physiologique du patient pour ajuster les paramètres de traitement par ventilation artificielle.
Le présent document s’applique également aux accessoires conçus par leur fabricant pour être raccordés au système respiratoire d’un ventilateur ou à un ventilateur, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles du ventilateur.
NOTE 5 Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si cela n’est pas le cas, 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 6 Des informations supplémentaires peuvent être trouvées dans l’IEC 60601‑1:2005+AMD1:2012+ AMD2:2020, 4.2.
Le présent document n’est applicable à aucun appareil EM ni système EM fournissant un mode de fonctionnement du ventilateur uniquement destiné à des patients non dépendants de la ventilation artificielle.
NOTE 7 Lorsqu’il fonctionne selon un tel mode de fonctionnement de ventilateur, un ventilateur pour utilisation en soins intensifs n’est pas considéré comme essentiel au maintien de la vie.
Le présent document ne s’applique pas aux appareils EM uniquement destinés à augmenter la ventilation des patients respirant spontanément au sein d’un établissement de soins professionnel.
Le présent document ne spécifie pas les exigences relatives aux:
N
Medicinska električna oprema - 2-12. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ventilatorjev za intenzivno nego (ISO 80601-2-12:2023)
Ta dokument se uporablja za osnovno varnost in bistvene lastnosti ventilatorjev za intenzivno nego v kombinaciji z dodatno opremo, v nadaljevanju: elektromedicinska oprema:
namenjeno uporabi v okolju, kjer se izvaja posebna oskrba pacientov, katerih stanja so lahko
smrtno nevarna in ki potrebujejo celostno oskrbo in stalno spremljanje v strokovni zdravstveni ustanovi;
OPOMBA 2: Za namene tega dokumenta to okolje imenujemo okolje intenzivne nege. Ventilatorji za to okolje veljajo za ventilatorje, ki ohranjajo življenje.
OPOMBA 3: Za namene tega dokumenta lahko takšen ventilator za intenzivno nego omogoča
prevoz oziroma premikanje znotraj strokovne zdravstvene ustanove (tj. ventilator za delovanje med prevozom).
OPOMBA 4: Ventilator za intenzivno nego, namenjen za prevoz znotraj strokovne zdravstvene ustanove, se ne šteje za ventilator v okolju nujne medicinske pomoči.
namenjen upravljanju, ki ga izvaja zdravstveni delavec operater; in
namenjen tistim pacientom, ki potrebujejo različne stopnje podpore z umetnim dihanjem, vključno z od aparata odvisnimi pacienti.
Ventilator za intenzivno nego ni namenjen uporabi v fizioloških sistemih z zaprtozančnim krmiljenjem, razen če uporablja fiziološko spremenljivko pacienta za prilagajanja nastavitev zdravljenja z umetnim dihanjem.
Ta dokument se prav tako uporablja za tiste dodatke, ki jih je proizvajalec predvidel za priklop na dihalni sistem ventilatorja, ali na ventilator, kjer lahko lastnosti teh dodatkov vplivajo na osnovno varnost ali bistvene lastnostni ventilatorja: OPOMBA 5: Če je točka ali podtočka namenjena samo obravnavi elektromedicinske opreme, 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 sistemov, ki spadajo na področje uporabe tega dokumenta, razen standarda IEC 60601-
1:2005+AMD1:2012+AMD2:2020, točki 7.2.13 in 8.4.1.
OPOMBA 6: Dodatne informacije so navedene v standardu IEC 60601-1:2005+AMD1:2012+AMD2:2020,
4.2. Ta dokument se ne uporablja za elektromedicinsko opremo ali sistem, ki upravlja način delovanja ventilatorja samo za paciente, ki niso odvisni od umetnega dihanja.
OPOMBA 7: Ventilator za intenzivno nego, ki se ga upravlja v tem načinu delovanja, ni namenjen ohranjanju življenja.
Ta dokument se ne uporablja za elektromedicinsko opremo, ki je namenjena izključno za izboljšanje predihavanja
pacientov, ki v strokovni zdravstveni ustanovi dihajo spontano.
Ta dokument ne določa zahtev za:
OPOMBA 8: Glej ISO/TR 21954 za navodila glede izbire ustreznega ventilatorja za določenega pacienta.
ventilatorje ali dodatno opremo za anestezijsko uporabo, ki so podani v standardu ISO 80601‑2‑13;
ventilatorje ali dodatno opremo za uporabo v okolju nujne medicinske pomoči, ki so podani v standardu
ISO 80601-2-84;
ventilatorje ali dodatno opremo za uporabo pri od aparata odvisnih bolnikih v domači zdravstveni oskrbi, ki so podani v standardu ISO 80601‑2‑72;
ventilatorje ali dodatno opremo za podporne naprave ventilatorjev za uporabo v domači oskrbi, ki so podani v standardu ISO 80601-2-79 in ISO 80601-2-80;
elektromedicinsko opremo za zdravljenje sindroma obstruktivne apneje v spanju, ki je podana v standardu ISO 80601‑2‑70;
elektromedicinsko opremo za vzdrževanje stalnega tlaka v dihalnih poteh (CPAP).
ventilatorje za visokofrekvenčno predihavanje, ki so podani v standardu ISO 80601-2-87;
OPOMBA 9: Ventilator za intenzivno nego lahko vključuje načina delovanja z visokofrekvenčnim pospešenim predihavanjem ali visokofrekvenčnim oscilacijskim predihavanjem.
opremo za zdravljenje z visokim tokom predihavanja, ki je podana v standardu ISO 80601-2-90;
OPOMBA 10: Ventilator za intenzivno nego lahko vključuje način delovanja za zdravljenje z visokim pretokom, vendar je ta namenjen samo za paciente
General Information
Relations
Overview
SIST EN ISO 80601-2-12:2024 (identical to EN ISO 80601-2-12:2023 / ISO 80601-2-12:2023) specifies the particular requirements for the basic safety and essential performance of critical care ventilators as medical electrical equipment. It applies to ventilators intended for use in a critical care environment (life‑sustaining devices used by healthcare professionals, including transit‑operable ventilators within healthcare facilities) and to accessories whose characteristics can affect ventilator safety or performance. This edition supersedes the 2020 version and aligns with the latest IEC 60601 series amendments.
Key topics and technical requirements
The standard addresses a wide set of technical areas relevant to design, manufacture, testing and labelling of critical care ventilators:
- Scope and definitions - clear definition of critical care ventilators, life‑sustaining classification, and exclusions (e.g., anaesthetic ventilators, EMS ventilators, home‑care ventilators).
- Basic safety & essential performance - requirements that ensure ventilators operate safely for patients who may be ventilator‑dependent.
- Classification, identification and marking - device labelling, operator documentation and display requirements (including legibility while wearing personal protective equipment).
- Electrical and mechanical protection - safeguards against electrical shock, mechanical hazards, excessive temperatures and radiation.
- Accuracy of controls and instruments - performance criteria for flow, pressure and monitoring instruments and protection against hazardous outputs.
- Alarm systems & usability - alarm design, human factors (usability), and guidance for alarm thresholds and operator interaction.
- Programmable electrical medical systems (PEMS) - requirements for software and control systems used in ventilators.
- Gas connections & ventilator breathing system (VBS) - requirements for gas interfaces and accessories that affect performance.
- Fault‑handling & recovery - requirements for hazardous situations, ventilator system recovery and spontaneous breathing during loss of ventilation.
- Electromagnetic compatibility (EMC) and data interfaces - EMC tests and informative guidance on digital interfaces, cybersecurity and labelling harmonized with ISO 20417.
Practical applications - who uses this standard
- Manufacturers and design engineers - to design ventilators that meet regulatory safety and performance expectations.
- Test laboratories and conformity assessors - for type testing and certification against ISO/IEC medical device requirements.
- Regulatory bodies and notified bodies - to assess compliance for market approval and post‑market surveillance.
- Clinical engineers and hospital procurement - to evaluate device suitability, interoperability and safety for critical care settings.
- Risk managers and usability specialists - to align ventilator features with clinical workflows and alarm management.
Related standards
- IEC/ISO 60601 series (collateral and general requirements)
- ISO 80601‑2‑13 (anaesthetic ventilators)
- ISO 80601‑2‑72, ‑79, ‑80 (home and ventilator‑dependent patient devices)
- ISO 80601‑2‑84 (EMS environment ventilators)
- ISO 20417 (medical device labelling)
This standard is essential for anyone involved in the lifecycle of critical care ventilators, from concept and design through testing, certification and clinical deployment.
Frequently Asked Questions
SIST EN ISO 80601-2-12:2024 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)". This standard covers: 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
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
SIST EN ISO 80601-2-12:2024 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.
SIST EN ISO 80601-2-12:2024 has the following relationships with other standards: It is inter standard links to SIST EN ISO 80601-2-12:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 80601-2-12:2024 is associated with the following European legislation: EU Directives/Regulations: 2017/745; Standardization Mandates: M/571, M/575. 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.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN ISO 80601-2-12:2020
Medicinska električna oprema - 2-12. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ventilatorjev za intenzivno nego (ISO 80601-2-12:2023)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and
essential performance of critical care ventilators (ISO 80601-2-12:2023)
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die
Intensivpflege (ISO 80601-2-12:2023)
Appareils électromédicaux - Partie 2-12: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation
en soins intensifs (ISO 80601-2-12:2023)
Ta slovenski standard je istoveten z: EN ISO 80601-2-12:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 80601-2-12
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-12:2020
English Version
Medical electrical equipment - Part 2-12: Particular
requirements for basic safety and essential performance of
critical care ventilators (ISO 80601-2-12:2023)
Appareils électromédicaux - Partie 2-12: Exigences Medizinische elektrische Geräte - Teil 2-12: Besondere
particulières relatives à la sécurité de base et aux Festlegungen für die Sicherheit einschließlich der
performances essentielles des ventilateurs wesentlichen Leistungsmerkmale von
pulmonaires pour utilisation en soins intensifs (ISO Beatmungsgeräten für die Intensivpflege (ISO 80601-
80601-2-12:2023) 2-12:2023)
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 80601-2-12:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-12:2023) 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 ISO 80601-2-12:2020.
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 80601-2-12:2023 has been approved by CEN as EN ISO 80601-2-12:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-12
Third edition
2023-11
Medical electrical equipment —
Part 2-12:
Particular requirements for basic
safety and essential performance of
critical care ventilators
Appareils électromédicaux —
Partie 2-12: Exigences particulières relatives à la sécurité de base
et aux performances essentielles des ventilateurs pulmonaires pour
utilisation en soins intensifs
Reference number
ISO 80601-2-12:2023(E)
ISO 80601-2-12:2023(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
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80601-2-12:2023(E)
Contents
Foreword . v
Introduction . vii
201. 1 Scope, object and related standards .1
201. 1.1 Scope .1
201. 1.2 Object .3
201. 1.3 Collateral standards . 3
201. 1.4 Particular standards .3
201. 2 Normative references .4
201. 3 Terms and definitions .6
201. 4 General requirements . 25
201. 5 General requirements for testing of ME equipment . 29
201. 6 Classification of ME equipment and ME systems . 30
201. 7 ME equipment identification, marking and documents . 30
201. 8 Protection against electrical hazards from ME equipment . 37
201. 9 Protection against mechanical hazards of ME equipment and ME systems 37
201. 10 Protection against unwanted and excessive radiation hazards . 41
201. 11 Protection against excessive temperatures and other hazards . 41
201. 12 Accuracy of controls and instruments and protection against hazardous
outputs . 45
201. 12.1 Accuracy of controls and instruments . 45
201. 13 Hazardous situations and fault conditions for ME equipment . 63
201. 14 Programmable electrical medical systems (PEMS) . 65
201. 15 Construction of ME equipment . 66
201. 16 ME systems . 70
201. 17 Electromagnetic compatibility of ME equipment and ME systems . 70
201. 101 Gas connections . 70
201. 102 Requirements for the VBS and accessories . 74
201. 103 Spontaneous breathing during loss of ventilation . 76
201. 104 Indication of duration of operation . 76
201. 105 Functional connection . 77
201. 106 Display loops . 77
201. 107 Timed ventilatory pause . 78
202 Electromagnetic disturbances — Requirements and tests . 80
206 Usability . 81
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 83
Annex C (informative) Guide to marking and labelling requirements for
ME equipment and ME systems . 86
ISO 80601-2-12:2023(E)
Annex D (informative) Symbols on marking . 92
Annex AA (informative) Particular guidance and rationale . 94
Annex BB (informative) Data interfaces . 134
Annex CC (informative) Reference to the IMDRF essential principles and labelling
guidances . 143
Annex DD (informative) Reference to the essential principles . 146
Bibliography . 149
Alphabetized index of defined terms . 154
iv © ISO 2023 – All rights reserved
ISO 80601-2-12:2023(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical activity.
ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives or
www.iec.ch/members_experts/refdocs).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights.
Details of any patent rights identified during the development of the document will be in the
Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents) or the
IEC list of patent declarations received (see https://patents.iec.ch).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
Technical Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC 62D,
Particular medical equipment, software, and systems, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 80601-2-12:2020), which has been
technically revised.
The main changes are as follows:
— alignment with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 and IEC 60601-1-8:2006+AMD1:2012+AMD2:2020.
— added requirements for the display legibility for operators wearing personal protective equipment;
— added requirements for display during calibration of gas monitors;
— clarified maximum limited pressure requirements;
— clarified high airway pressure alarm condition requirements;
— added requirements for ventilator system recovery;
ISO 80601-2-12:2023(E)
— added requirements and definitions for cybersecurity; and
— harmonization with ISO 20417, where appropriate.
A list of all parts in the ISO and IEC 80601 series can be found on the ISO and IEC websites.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html and www.iec.ch/national-
committees.
vi © ISO 2023 – All rights reserved
ISO 80601-2-12:2023(E)
Introduction
In referring to the structure of this document, the term
— “clause” means one of the four numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);
— “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.12 are all
subclauses of Clause 201).
References to clauses within this document are preceded by the term “Clause” followed by the clause
number. References to subclauses within this document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— "can" is used to describe a possibility or capability.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
Requirements in this document have been decomposed so that each requirement is uniquely
delineated. This is done to support automated requirements tracking.
INTERNATIONAL STANDARD ISO 80601-2-12:2023(E)
Medical electrical equipment —
Part 2-12:
Particular requirements for basic safety and essential
performance of critical care ventilators
201.1 Scope, object and related standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
201.1.1 Scope
Replacement:
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 a critical care ventilator 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 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.
intended to be operated by a healthcare professional operator; and
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.
ISO 80601-2-12:2023(E)
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.
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;
ventilators or accessories intended for home-care ventilatory support devices, 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;
continuous positive airway pressure (CPAP) ME equipment.
high-frequency ventilators, which are given in ISO 80601-2-87;
NOTE 9 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory
ventilator-operational modes.
respiratory high-flow therapy equipment, which are given in ISO 80601-2-90;
NOTE 10 A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is
only for spontaneously breathing patients.
oxygen therapy constant flow ME equipment; and
cuirass or “iron-lung” ventilation equipment.
2 © ISO 2023 – All rights reserved
ISO 80601-2-12:2023(E)
201.1.2 Object
Replacement:
The object of this document is to establish basic safety and essential performance requirements for a
ventilator, as defined in 201.3.306, and its accessories.
Accessories are included because the combination of the ventilator and the accessories needs to be
adequately safe. Accessories can have a significant impact on the basic safety or essential performance of
a ventilator.
[42] [43]
NOTE 1 This document has been prepared to address the relevant essential principles and labelling
guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.
NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance
of ISO 16142-1:2016 as indicated in Annex DD.
NOTE 3 This document has been prepared to address the relevant general safety and performance requirements
of European regulation (EU) 2017/745.
201.1.3 Collateral standards
Amendment (add after existing text):
This document refers to those applicable collateral standards that are listed in Clause 2 of the general
standard and in 201.2 of this document.
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 and
IEC 60601-1-8:2016+AMD1:2012+AMD2:2020 apply as modified in Clauses 202, 206 and 208
respectively.
IEC 60601-1-3, IEC 60601-1-9, IEC 60601-1-11 and IEC 60601-1-12 do not apply.
All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in
the general standard, including the collateral standards, as appropriate for the particular ME equipment
under consideration, and may add other basic safety or essential performance requirements.
A requirement of a particular standard takes priority over IEC 60601-1:2005+AMD1:2012+AMD2:2020
or the collateral standards.
For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the general
standard. Collateral standards are referred to by their document number.
ISO 80601-2-12:2023(E)
The numbering of clauses and subclauses of this document corresponds to those of the general
standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the
general standard) or applicable collateral standard with the prefix “2xx” where xx are the final digits of
the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4
of the IEC 60601-1-2 collateral standard, 208.4 in this document addresses the content of Clause 4 of
the IEC 60601-1-8 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
“Replacement” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+AMD2:2020 or
the applicable collateral standard is replaced completely by the text of this document.
“Addition” means that the text of this document is additional to the requirements of
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the
applicable collateral standard is amended as indicated by the text of this document.
Subclauses, figures or tables that are additional to those of the general standard are numbered starting
from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1
through 3.154, additional definitions in this document are numbered beginning from 201.3.201.
Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from
20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 208 for IEC 60601-1-
8, etc.
The term “this document” is used to make reference to the general standard, any applicable collateral
standards and this particular document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly
not relevant, applies without modification; where it is intended that any part of
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly
relevant, is not to be applied, a statement to that effect is given in this particular document.
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
4 © ISO 2023 – All rights reserved
ISO 80601-2-12:2023(E)
ISO 5359:2014+AMD1:2017, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for
use with medical gases
ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed
medical gases and vacuum
ISO 9360-1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having
minimum tidal volumes of 250 ml
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562-1:2023, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
to assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
ISO 80601-2-55:2018, Medical electrical equipment — Part 2-55: Particular requirements for the basic
safety and essential performance of respiratory gas monitors
ISO 80601-2-74:2021, Medical electrical equipment — Part 2-74: Particular requirements for basic safety
and essential performance of respiratory humidifying equipment
IEC 60068-2-27:2008, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks,
primarily for equipment-type specimens
IEC 60068-2-64:2008+AMD1:2019, Environmental testing — Part 2-64: Tests — Test Fh: Vibration,
broadband random and guidance
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
ISO 80601-2-12:2023(E)
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
IEC Guide 115:2021, Application of uncertainty of measurement to conformance assessment activities in
the electrotechnical sector
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+AMD1:2012+AMD2:2020 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
201.3.201
accompanying information
information accompanying or marked on a medical device or accessory for the user or those accountable
for the installation, use, processing, maintenance, decommissioning and disposal of the medical device
or accessory, particularly regarding safe use
Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
description, installation manual, quick reference guide, etc.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types (e.g., CD/DVD-ROM, USB stick, website).
[SOURCE: ISO 20417:2021, 3.2, modified — deleted note 4.]
201.3.202
acknowledged
state of an alarm system initiated by operator action, where the auditory alarm signal associated with a
currently active alarm condition is inactivated until the alarm condition no longer exists or until a
predetermined time interval has elapsed
Note 1 to entry: Acknowledged only affects alarm signals that are active at the time of the operator action.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.37]
201.3.203
airway device
device intended to provide a gas pathway to and from the patient’s airway
[SOURCE: ISO 4135:2022, 3.8.1.2]
6 © ISO 2023 – All rights reserved
ISO 80601-2-12:2023(E)
201.3.204
airway pressure
P
aw
pressure at the patient-connection port or at the distal outlet of the equipment where there is no patient-
connection port
Note 1 to entry: The airway pressure can be derived from pressure measurements made anywhere within the
equipment.
[SOURCE: ISO 4135:2022, 3.1.4.41.1]
201.3.205
alarm condition delay
time from the occurrence of a triggering event either in the patient, for physiological alarm conditions, or
in the equipment, for technical alarm conditions, to when the alarm system determines that an alarm
condition exists
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.2]
201.3.206
alarm limit
threshold used by an alarm system to determine an alarm condition
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]
201.3.207
alarm off
state of indefinite duration in which an alarm system or part of an alarm system does not generate alarm
signals
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.4]
201.3.208
alarm paused
state of limited duration in which the alarm system or part of the alarm system does not generate alarm
signals
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.5]
201.3.209
alarm setting
alarm system configuration, including but not limited to:
– alarm limits;
– the characteristics of any alarm signal inactivation states; and
– the values of variables or parameters that determine the function of the alarm system
Note 1 to entry: Some algorithmically-determined alarm settings can require time to be determined or re-
determined.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.8]
201.3.210
artificial ventilation
intermittent elevation of the pressure in the patient's airway relative to that in the lungs by external
means with the intention of augmenting, or totally controlling, the ventilation of a patient
EXAMPLE Means used to provide artificial ventilation are manual resuscitation; mouth-to-mouth
resuscitation; automatic ventilation; mechanical ventilation.
ISO 80601-2-12:2023(E)
Note 1 to entry: Common classifications of areas of application of artificial ventilation are: emergency; transport;
home-care; anaesthesia; critical care; rehabilitation.
Note 2 to entry: Classifications used to denote means used for artificial ventilation include: positive-pressure;
negative-pressure; gas-powered; operator-powered; electrically-powered.
Note 3 to entry: Negative-pressure ventilation elevates the relative pressure in the airway by intermittently
lowering the pressure in the lungs.
[SOURCE: ISO 19223:2019, 3.1.10]
201.3.211
assured inflation-type rate
number of assured inflation-type initiations in a specified period of time, expressed as breaths per
minute
[SOURCE: ISO 19223:2019, 3.5.2.1, modified — deleted notes.]
201.3.212
attack
attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized use
of an asset
,
[SOURCE: IEC 81001-5-1, 3.5]
201.3.213
audio off
state of indefinite duration in which the alarm system or part of the alarm system does not generate an
auditory alarm signal
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.12]
201.3.214
audio paused
state of limited duration in which the alarm system or part of the alarm system does not generate an
auditory alarm signal
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.13]
201.3.215
BAP
quantity by which the baseline airway pressure is set to be positively offset from the ambient pressure
[SOURCE: ISO 19223:2019, 3.10.2, modified — deleted notes.]
201.3.216
bias flow
flow that passes through the ventilator breathing system to the exhaust port but is not intended to
contribute to the work of lung ventilation
[SOURCE: ISO 19223:2019, 3.7.7, modified — deleted notes.]
201.3.217
biocompatibility
ability to be in contact with a living system without producing an unacceptable adverse effect
Note 1 to entry: A medical devices or accessory may produce some level of adverse effect, but that level may be
determined to be acceptable when considering the benefits provided by the medical device or accessory.
8 © ISO 2023 – All rights reserved
ISO 80601-2-12:2023(E)
[SOURCE: ISO 18562-1:2023, 3.6]
201.3.218
body temperature and pressure saturated
BTPS
ambient atmospheric pressure, at a temperature of 37 °C, and a relative humidity of 100 %
[SOURCE: ISO 4135:2022, 3.1.1.7]
201.3.219
breathing system
pathways through which gas flows to or from the patient at respiratory pressures and continuously or
intermittently in fluid communication with the patient’s respiratory tract during any form of artificial
ventilation or respiratory therapy
[SOURCE: ISO 4135:2022, 3.6.1.1, modified — deleted notes.]
201.3.220
breathing system filter
BSF
device intended to reduce transmission of particulates, including microorganisms, in breathing systems
[SOURCE: ISO 23328-2:2002, 3.1]
201.3.221
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances, and other debris)
from the surfaces, crevices, serrations, joints and lumens of a medical device by a manual or automated process
that prepares the items for safe handling or further processing.
[SOURCE: ISO 17664-2:2021, 3.1, modified — replaced 'and/or' with 'or'.]
201.3.222
communicator
COM
function of the alarm system that generates alarm signals to notify an operator (e.g. to the presence of an
alarm condition)
Note 1 to entry: A communicator can receive an operator response.
Note 2 to entry: An operator response is not limited to direct operator action.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.46, modified — deleted note 3.]
201.3.223
connector
fitting to join two or more components
EXAMPLE Connectors for low-pressure hose assembly are any of a range of mating components intended to
maintain gas specificity by the allocation of a set of different diameters to the mating connectors for each
particular gas.
[SOURCE: ISO 4135:2022, 3.1.4.5]
ISO 80601-2-12:2023(E)
201.3.224
continuous flow
gas flowing continuously through the ventilator breathing system, with a proportion intermittently
passing to the patient's lung whenever the airway pressure is raised by the ventilator or an operator
action, or flow is demanded by a patient's inspiratory effort
[SOURCE: ISO 19223:2019, 3.7.8, modified — deleted notes.]
201.3.225
CPAP
continuous positive airway pressure
ventilation-mode or sleep-apnoea breathing-therapy mode in which the patient breathes continuously
at a set airway-pressure level, above ambient pressure
[SOURCE: ISO 19223:2019, 3.11.15, modified — deleted notes.]
201.3.226
cybersecurity
state where information and systems are protected from unauthorized activities, such as access, use,
disclosure, disruption, modification, or destruction to a degree that the related risks to violation of
confidentiality, integrity, and availability are maintained at an acceptable level throughout the life cycle
,
[SOURCE: IEC 81001-5-1, 3.30]
201.3.227
Δ inspiratory pressure
differential airway pressure relative to baseline airway pressure during an inflation phase
Note 1 to entry: In addition to its direct reference, this term or an appropriate symbol may be used, in context or
by qualification, to designate this concept as a set quantity or a measured quantity.
Note 2 to entry: There is currently no agreed convention as to whether an inspiratory pressure is always to be
expressed as an absolute quantity relative to ambient pressure or an absolute quantity for one group of inflation-
types and relative for another. This has unacceptable patient-safety implications that need to be addressed in a
vocabulary of lung ventilation. The symbol, Δ, is currently sometimes used as a prefix to make this distinction, and
that convention has been adopted as a requirement in this document. Without a prefix, or any other indication,
respiratory pressures are always to be considered to be relative to ambient pressure. The addition of a Δ prefix, is
used to indicates a pressure that is relative to the set BAP level. In ventilation-modes where there is a second,
higher, baseline airway pressure, then the prefix for a pressure relative to that higher-pressure level becomes ΔH.
These prefixes are applicable to relevant terms, symbols and displayed values but not to inflation-types.
Note 3 to entry: The sum of the set BAP level and the Δ inspiratory pressure equals the inspiratory pressure. This
applies to both settings and measurements of this parameter.
[SOURCE: ISO 19223:2019, 3.6.7, modified — deleted note 4.]
201.3.228
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a
defined purpose
[SOURCE: ISO 17664-2:2021, 3.5]
10 © ISO 2023 – All rights reserved
ISO 80601-2-12:2023(E)
201.3.229
distributed alarm system
DAS
alarm system that involves more than one item of equipment of a ME system intended for delivery of
alarm conditions with technical confirmation
Note 1 to entry: The parts of a distributed alarm system can be widely separated in distance.
Note 2 to entry: A distributed alarm system is intended to notify operators of the existence of an alarm condition.
Note 3 to entry: For the purposes of this document, technical confirmation means that each element of a
distributed alarm system confirms or guarantees the successful delivery of the alarm condition to the next element
or appropriate technical alarm conditions are created as described in
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 6.11.2.2.1.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.17]
201.3.230
distributed information system about alarm conditions
DIS
system that involves more than one item of equipment in a ME system intended to provide information
about alarm conditions but does not guarantee delivery of that information
Note 1 to entry: A distributed information system about alarm conditions is not intended to notify operators of the
existence of an alarm condition as a risk control measure. A distributed information system about alarm conditions
is intended to provide information about an alarm condition while the operator is aware of the existence of the
alarm condition by an alarm system.
Note 2 to entry: A distributed information system about alarm conditions is not intended for confirmed delivery of
alarm conditions.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.48]
201.3.231
emergency intake
dedicated gas intake port through which gas is drawn when the supply of fresh gas or inflating gas is
insufficient or absent
[SO
...
La norme SIST EN ISO 80601-2-12:2024 présente des exigences spécifiques relatives à la sécurité de base et à la performance essentielle des ventilateurs de soins critiques, un équipement médical électrique destiné à être utilisé dans des environnements de soins spécialisés où les patients sont en danger de mort et nécessitent des soins complets ainsi qu'une surveillance constante. Ce document s’applique non seulement aux ventilateurs eux-mêmes, mais aussi aux accessoires qui peuvent influencer la sécurité et la performance fondamentale du ventilateur. L'un des points forts de cette norme est son approche rigoureuse quant à la définition de ce qu'est un ventilateur de soins critiques. Elle précise que ces dispositifs sont considérés comme vitaux pour la vie, et qu'ils peuvent également être utilisés pour la ventilation durant le transport au sein d'un établissement de santé professionnel. Cela souligne l'importance de la flexibilité et de l'adaptabilité du ventilateur dans des situations potentiellement critiques. La norme détaille aussi les exigences concernant les opérateurs de ce système, stipulant clairement que seuls les professionnels de la santé formés sont habilités à utiliser ces équipements. Cela contribue à garantir non seulement la sécurité du patient, mais aussi celle de l'opérateur, en soulignant que la formation joue un rôle clé dans l'utilisation appropriée des ventilateurs de soins critiques. Un autre aspect essentiel de cette norme est son exclusion des dispositifs destinés aux patients qui ne nécessitent pas de ventilation artificielle, ce qui permet de concentrer les exigences sur les patients qui en ont réellement besoin, comme les patients dépendants des ventilateurs. Cela montre la pertinence de la norme pour les scénarios cliniques spécifiques et contribue à établir des lignes directrices claires pour les fabricants et les utilisateurs finaux. En outre, les notes explicatives insérées dans le texte fournissent un contexte précieux, en orientant les utilisateurs vers d'autres normes lorsque cela est nécessaire, par exemple, en ce qui concerne les ventilateurs utilisés dans d'autres environnements médicaux comme l'anesthésie ou les soins à domicile. Dans l'ensemble, la norme SIST EN ISO 80601-2-12:2024 se distingue par son approche ciblée et sa spécificité concernant les ventilateurs de soins critiques. Sa pertinence pour le secteur médical ne peut être sous-estimée, en tant qu'outil garantissant la sécurité des patients et l'efficacité des soins prodigués dans des situations critiques.
Die SIST EN ISO 80601-2-12:2024 ist ein wesentlicher Standard, der spezifische Anforderungen an die grundlegende Sicherheit und die wesentliche Leistung von Beatmungsgeräten in kritischen Pflegeumgebungen festlegt. Dieser Standard ist besonders relevant für medizinische Fachkräfte, die in professionellen Gesundheitseinrichtungen tätig sind, in denen die Patientenversorgung eine lebensbedrohliche Dimension erreichen kann. Der Anwendungsbereich des Standards beschreibt detailliert die Funktionsweise von kritischen Beatmungsgeräten und deren Zubehör. Es wird deutlich, dass diese Geräte für eine sichere Handhabung durch geschultes Personal konzipiert sind und für Patienten bestimmt sind, die unterschiedliche Unterstützungsniveaus bei der künstlichen Beatmung benötigen. Besonders hervorzuheben ist die Klarstellung, dass kritische Beatmungsgeräte als lebenserhaltend angesehen werden, was ihre zentrale Rolle in der Patientenversorgung unterstreicht. Die Stärken des Standards liegen in seiner umfassenden Betrachtung der zugrunde liegenden Sicherheitsanforderungen und der essenziellen Leistungsparameter, die dafür sorgen, dass die Beatmungsgeräte in einer kritischen Pflegeumgebung zuverlässig funktionieren. Die Berücksichtigung von Zubehör, das an Beatmungssysteme angeschlossen werden kann, stellt sicher, dass die Grundsicherheit und Leistung nicht nur durch das Hauptgerät, sondern auch durch alle damit verbundenen Komponenten gewährleistet sind. Ein weiteres wichtiges Merkmal ist die deutliche Abgrenzung zu anderen Standards, indem klar festgelegt wird, dass dieser Standard nicht für Beatmungsgeräte gilt, die ausschließlich für Patienten ohne Abhängigkeit von der künstlichen Beatmung bestimmt sind. Dies erhöht die Relevanz des Standards, da er sich spezifisch auf die Bedürfnisse von Patienten konzentriert, die kritische Unterstützung benötigen. Insgesamt bietet die SIST EN ISO 80601-2-12:2024 eine klare und strukturierte Grundlage für die Entwicklung und den Betrieb von kritischen Beatmungsgeräten und deren Zubehör, was letztendlich die Sicherheitsstandards in medizinischen Einrichtungen fördert und die Versorgung von Patienten in kritischen Zuständen verbessert.
SIST EN ISO 80601-2-12:2024は、重篤な患者に対する基本的な安全性と必須性能に関する特定要件を定めた標準であり、医療電気機器、特にクリティカルケア用換気装置に焦点を当てています。この文書は、専門的な医療施設における重篤な患者のための特別なケアを提供する環境を対象としており、換気装置が命を維持するための機器としての重要な役割を果たします。 本標準の強みの一つは、その包括的な範囲です。換気装置のアクセサリが換気システムに接続される場合、これらの特性が基本的な安全性または必須性能に影響を与える可能性についても言及されています。この点により、換気装置とそのアクセサリの整合性が保たれ、全体としての安全性が向上します。また、異なるレベルの人工換気を必要とする患者への適用が明確にされており、特に換気依存の患者に対する適切な治療を保証するための基準が設けられています。 さらに、クリティカルケア用換気装置は、医療専門家によって操作されることが前提とされており、専門的なトレーニングを受けたスタッフによる安全な操作が促進されています。これにより、患者の健康状態が危険にさらされるリスクを最小限に抑えることが可能です。 重要なのは、この標準が医療機器の安全性を確保するだけでなく、換気装置が利用されるクリティカルケア環境において、患者のニーズに応じた信頼性の高い性能を提供することにあります。医療現場でのニーズに応じた適切な換気装置の選定に関するガイダンスも提供されており、医療従事者が最適な治療を行うための支援材料として機能しています。 全体として、SIST EN ISO 80601-2-12:2024は、クリティカルケア用換気装置の運用における基本的な安全性と性能を確保するための重要なフレームワークを提供し、医療現場における患者の安全を守るための必須な文書といえます。
SIST EN ISO 80601-2-12:2024 표준은 중환자 치료를 위한 인공호흡기와 그 액세서리에 대한 기본 안전성과 필수 성능을 정의하고 있습니다. 이 표준은 생명이 위협받는 환자에게 전문적인 의료 시설에서 제공되는 특수 치료 환경, 즉 중환자 치료 환경에서 사용하기 위해 설계된 인공호흡기에 적용됩니다. 이 표준의 강점은 생명 유지 기능을 갖춘 중환자 인공호흡기에 대해 명확한 요구사항을 제시한다는 점입니다. 또한, 의료 전문가가 조작하는 인공호흡기를 고려하고 있으며, 다양한 수준의 인공환기 지원이 필요한 환자를 대상으로 하고 있습니다. 이는 인공호흡기와 그 액세서리가 환자의 안전 및 치료 성능에 미치는 영향을 최소화하고, 높은 안정성을 보장하기 위한 중요한 기준입니다. 이 표준은 또한 인공호흡기를 연결하기 위해 제조된 액세서리와 관련하여도 적용됩니다. 이러한 액세서리가 인공호흡기의 기본 안전성이나 필수 성능에 미치는 영향을 고려하여 요구사항을 설정합니다. 이로 인해 의료 현장에서 발생할 수 있는 잠재적인 위험을 미리 예방하고, 환자의 안전을 보장하는 데 기여합니다. SIST EN ISO 80601-2-12:2024의 적용 범위는 인공호흡기가 주로 중환자 치료 환경에서 사용됨을 명시하고 있으며, 이러한 표준은 의료 기기에 대한 최신 요구사항과 규정을 반영하고 있습니다. 또한, 일반적인 환자뿐만 아니라 인공환기 의존도가 높은 환자들에 대해서도 충분한 지침을 제공하므로, 실무에서 매우 중요한 역할을 수행합니다. 전반적으로 SIST EN ISO 80601-2-12:2024 표준은 중환자 치료를 위한 인공호흡기와 그 액세서리에 필요한 안전성과 성능을 체계적으로 규명하여, 치료의 질을 향상시키는 데 큰 기여를 합니다.
The SIST EN ISO 80601-2-12:2024 standard is a comprehensive document that focuses on the particular requirements for basic safety and essential performance of critical care ventilators. Its scope is specifically tailored to medical electrical (ME) equipment used in critical care environments, where the well-being of patients with life-threatening conditions is paramount. This standard outlines essential criteria for ventilators, ensuring their operational safety and reliability when utilized by healthcare professionals in settings that necessitate continuous patient monitoring and advanced care. One of the significant strengths of this standard is its precise definition of critical care ventilators, recognizing their life-sustaining role in both stationary and transit-operable forms within healthcare facilities. The clarity provided regarding the intended use of the equipment is vital for healthcare professionals, as it outlines the specific patient groups who require varying levels of support from artificial ventilation, particularly ventilator-dependent patients. The standard also addresses the accessories associated with critical care ventilators, which can significantly impact the basic safety and essential performance of the ventilator systems. By encompassing these accessories, the document enhances the overall safety framework, emphasizing that any variations in accessory functionality could affect patient care directly. Moreover, the standard provides precise exclusions, distinguishing between ventilators used for life-sustaining applications and those meant for aiding spontaneously breathing patients or intended for home healthcare settings. This creates a clear demarcation that is essential for practitioners in selecting the appropriate ventilator. Additionally, it clarifies that ventilators operating in certain modes are not included in these requirements, thus preventing any misinterpretations in their application. The relevance of the SIST EN ISO 80601-2-12:2024 standard cannot be overstated. It is particularly crucial for ensuring that critical care ventilators function optimally and safely, aligning with the high stakes of critical care environments where patient lives are at risk. This standard provides the necessary guidelines that help to ensure the safety and efficacy of ventilatory support across diverse healthcare situations, which is essential in today's complex medical landscape.
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