EN ISO 80601-2-12:2020
(Main)Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 3 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 utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to 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 4 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, 7.2.13 and 8.4.1.
NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 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 6 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:
ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[2];
ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4];
ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72:2015[5];
ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7][1];
obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[9];
continuous positive airway pressure (CPAP) ME equipment;
high-frequen
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege (ISO 80601-2-12:2020)
Abschnitt 1 der Allgemeinen Festlegungen gilt mit folgenden Abweichungen:
ANMERKUNG Die Allgemeinen Festlegungen sind IEC 60601 1:2005 + A1:2012.
1.1.1 Anwendungsbereich
Ersatz:
Dieses Dokument gilt für die Sicherheit und die wesentlichen Leistungsmerkmale von Beatmungs¬geräten 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 Beatmungseinstellungen 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.
[...]
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 80601-2-12:2020)
Le présent document s'applique à la sécurité de base et aux performances essentielles d'un ventilateur associé à ses accessoires, ci-après désignés par appareil EM:
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 1 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 au maintien de la vie.
NOTE 2 Pour les besoins du présent document, un tel ventilateur peut être associé au transport à l'intérieur d'un établissement de soins professionnel (c'est-à-dire être un ventilateur opérationnel en déplacement).
NOTE 3 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.
prévu pour être utilisé par un opérateur professionnel de soins de santé; et
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.
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 4 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, 7.2.13 et 8.4.1.
NOTE 5 Des informations supplémentaires peuvent être trouvées dans l'IEC 60601-1:2005+AMD1:2012, 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 6 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:
ventilateurs ou accessoires prévus pour les applications en anesthésie, qui sont données dans l'ISO 80601-2-13[2];
ventilateurs
Medicinska električna oprema - 2-12. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ventilatorjev za intenzivno nego (ISO 80601-2-12:2020)
General Information
Relations
Frequently Asked Questions
EN ISO 80601-2-12:2020 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)". This standard covers: This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 3 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 utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to 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 4 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, 7.2.13 and 8.4.1. NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 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 6 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: ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[2]; ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4]; ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72:2015[5]; ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7][1]; obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[9]; continuous positive airway pressure (CPAP) ME equipment; high-frequen
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 3 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 utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to 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 4 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, 7.2.13 and 8.4.1. NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 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 6 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: ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[2]; ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4]; ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72:2015[5]; ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7][1]; obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[9]; continuous positive airway pressure (CPAP) ME equipment; high-frequen
EN ISO 80601-2-12:2020 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.
EN ISO 80601-2-12:2020 has the following relationships with other standards: It is inter standard links to EN ISO 80601-2-12:2011/AC:2011, EN ISO 80601-2-12:2011, EN ISO 80601-2-12:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 80601-2-12:2020 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 80601-2-12:2020 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2020
Nadomešča:
SIST EN ISO 80601-2-12:2011
SIST EN ISO 80601-2-12:2011/AC:2012
Medicinska električna oprema - 2-12. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ventilatorjev za intenzivno nego (ISO 80601-2-12:2020)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and
essential performance of critical care ventilators (ISO 80601-2-12:2020)
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die
Intensivpflege (ISO 80601-2-12:2020)
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 80601-2-12:2020)
Ta slovenski standard je istoveten z: EN ISO 80601-2-12:2020
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
March 2020
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-12:2011
English Version
Medical electrical equipment - Part 2-12: Particular
requirements for basic safety and essential performance of
critical care ventilators (ISO 80601-2-12:2020)
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-
80601-2-12:2020) 2-12:2020)
This European Standard was approved by CEN on 12 November 2019.
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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-12:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-12:2020) 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 September 2020, and conflicting national standards
shall be withdrawn at the latest by September 2020.
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 80601-2-12:2011.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-12:2020 has been approved by CEN as EN ISO 80601-2-12:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-12
Second edition
2020-02
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 80601-2-12:2020(E)
©
ISO 2020
ISO 80601-2-12:2020(E)
© ISO 2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 80601-2-12:2020(E)
Contents
201. 1 Scope, object and related standards . 1
201. 1.1 * Scope . 1
201. 1.2 Object . 2
201. 1.3 Collateral standards . 3
201. 1.4 Particular standards . 3
201. 2 Normative references . 4
201. 3 Terms and definitions . 7
201. 4 General requirements . 9
201. 4.3 Essential performance . 9
201. 4.3.101 * Additional requirements for essential performance . 9
201. 4.4 Additional requirements for expected service life . 9
201. 4.6 * ME equipment or ME system parts that contact the patient . 10
201. 4.11.101 * Additional requirements for pressurized gas input . 10
201. 4.11.101.1 Overpressure requirement . 10
201. 4.11.101.2 Compatibility requirement . 10
201. 5 General requirements for testing of ME equipment. 11
201. 5.101 Additional requirements for general requirements for testing
of ME equipment . 11
201. 5.101.1 Ventilator test conditions . 11
201. 5.101.2 * Gas flowrate and leakage specifications . 11
201. 5.101.3 * Ventilator testing errors . 11
201. 6 Classification of ME equipment and ME systems . 12
201. 7 ME equipment identification, marking and documents . 12
201. 7.2.3 * Consult accompanying documents . 12
201. 7.2.4.101 Additional requirements for accessories . 12
201. 7.2.13.101 Additional requirements for physiological effects . 12
201. 7.2.17.101 Additional requirements for protective packaging . 12
201. 7.2.18 External gas source . 13
201. 7.2.101 * Additional requirements for marking on the outside of
ME equipment or ME equipment parts . 13
201. 7.4.3 * Units of measurement . 14
201. 7.9.1 Additional general requirements . 14
201. 7.9.2.1.101 Additional general requirements . 14
201. 7.9.2.2.101 * Additional requirements for warnings and safety notices . 15
201. 7.9.2.8.101 * Additional requirements for start-up procedure . 16
201. 7.9.2.9.101 * Additional requirements for operating instructions . 16
201. 7.9.2.12 Cleaning, disinfection, and sterilization . 17
201. 7.9.2.14.101 * Additional requirements for accessories, supplementary
equipment, used material . 17
ISO 80601-2-12:2020(E)
201. 7.9.2.16.101 * Additional requirements for reference to the technical
description . 18
201. 7.9.3.1.101 * Additional general requirements . 18
201. 7.9.3.101 Additional requirements for the technical description . 18
201. 8 Protection against electrical hazards from ME equipment . 19
201. 9 Protection against mechanical hazards of ME equipment and ME systems 19
201. 9.6.2.1.101 * Additional requirements for audible acoustic energy . 19
201. 9.101 * Additional requirements for suction procedures . 20
201. 10 Protection against unwanted and excessive radiation hazards . 23
201. 11 Protection against excessive temperatures and other hazards . 23
201. 11.1.2.2 * Applied parts not intended to supply heat to a patient . 23
201. 11.6.5.101 * Additional requirements for ingress of water or particulate
matter into ME equipment or ME system . 23
201. 11.6.6 * Cleaning and disinfection of ME equipment or ME system . 24
201. 11.6.7 Sterilization of ME equipment or ME system . 24
201. 11.7 Biocompatibility of ME equipment and ME systems . 24
201. 11.8.101 * Additional requirements for interruption of the power
supply/supply mains to ME equipment . 25
201. 12 Accuracy of controls and instruments and protection against hazardous
outputs . 27
201. 12.1 * Accuracy of controls and instruments . 27
201. 12.1.101 * Volume-control inflation-type . 27
201. 12.1.102 * Pressure-control inflation-type . 31
201. 12.1.103 Other inflation-types . 34
201. 12.1.104 * Inspiratory volume monitoring . 35
201. 12.1.105 * Response of the ventilator to an increase in set O
concentration . 35
201. 12.4 Protection against hazardous output . 37
201. 12.4.101 Oxygen monitor . 37
201. 12.4.102 * Measurement of airway pressure . 38
201. 12.4.103 * Measurement of expired volume and low volume alarm
conditions . 39
201. 12.4.103.1 Ventilators intended to provide a tidal volume >50 ml . 39
201. 12.4.103.2 Ventilators intended to provide a tidal volume ≤50 ml . 40
201. 12.4.104 * Expiratory end-tidal CO monitoring equipment . 41
201. 12.4.105 * Maximum limited pressure protection device . 42
201. 12.4.106 * High airway pressure alarm condition and protection device 42
201. 12.4.107 PEEP alarm conditions . 43
201. 12.4.108 * Obstruction alarm condition . 44
201. 12.4.109 * Disconnection alarm condition . 45
201. 12.4.110 Protection against inadvertent setting of high airway pressure .
.................................................................................................................... 45
201. 12.101 * Protection against accidental or unintentional adjustments 45
201. 13 Hazardous situations and fault conditions for ME equipment . 46
iv © ISO 2020 – All rights reserved
ISO 80601-2-12:2020(E)
201. 13.2.101 * Additional specific single fault conditions . 46
201. 13.2.102 * Failure of one gas supply to a ventilator . 46
201. 13.2.103 * Independence of ventilation control function and related risk
control measures . 47
201. 13.2.104 * Failure of functional connection to a ventilator control or
monitoring means . 47
201. 14 Programmable electrical medical systems (PEMS) . 47
201. 14.101 Software life cycle . 48
201. 15 Construction of ME equipment . 48
201. 15.3.5.101 Additional requirements for rough handling . 48
201. 15.3.5.101.1 * Shock and vibration (robustness) . 48
201. 15.3.5.101.2 * Shock and vibration for a transit-operable ventilator during
operation . 49
201. 15.4.1 Construction of connectors . 51
201. 15.101 Mode of operation . 51
201. 15.102 Delivered oxygen concentration . 51
201. 15.103 Accessory self-check . 51
201. 16 ME systems . 52
201. 16.1.101 Additional general requirements for ME systems . 52
201. 16.2.101 * Additional general requirements for accompanying documents
of an ME system . 52
201. 17 Electromagnetic compatibility of ME equipment and ME systems. 52
201. 101 Gas connections . 52
201. 101.1 * Protection against reverse gas leakage . 52
201. 101.2 Connection to a high-pressure input port . 53
201. 101.2.1 Connector . 53
201. 101.2.2 * Filter . 53
201. 101.3 VBS connectors . 53
201. 101.3.1 * General . 53
201. 101.3.2 Other named ports . 53
201. 101.3.2.1 Patient-connection port . 53
201. 101.3.2.2 Gas output port and gas return port . 54
201. 101.3.2.3 Emergency intake port . 54
201. 101.3.2.4 Flow-direction-sensitive components. 54
201. 101.3.2.5 * Accessory port . 54
201. 101.3.2.6 Gas exhaust port . 55
201. 101.3.2.7 Temperature sensor port . 55
201. 102 Requirements for the VBS and accessories . 55
201. 102.1 * General . 55
201. 102.2 Labelling . 55
201. 102.3 Breathing tubes . 55
201. 102.4 * Water vapour management . 56
201. 102.4.1 Humidification system . 56
201. 102.4.2 Heat and moisture exchanger (HME) . 56
ISO 80601-2-12:2020(E)
201. 102.6 Breathing system filters . 56
201. 102.7 Ventilator breathing systems . 56
201. 102.7.1 * Leakage from complete VBS . 56
201. 102.7.2 * Non-invasive ventilation . 57
201. 103 * Spontaneous breathing during loss of power supply . 57
201. 104 * Indication of duration of operation . 57
201. 105 Functional connection . 58
201. 105.1 General . 58
201. 105.2 * Connection to an electronic health record . 58
201. 105.3 * Connection to a distributed alarm system . 58
201. 105.4 Connection for remote control . 58
201. 106 Display loops . 58
201. 106.1 Pressure-volume loops . 58
201. 106.2 Flow-volume loops . 59
201. 107 * Timed ventilatory pause. 59
201. 107.1 Expiratory pause . 59
201. 107.2 Inspiratory pause . 60
202 Electromagnetic disturbances — Requirements and tests . 61
206 Usability . 62
206.101 Primary operating functions . 62
206.102 * Training . 63
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 64
Annex C (informative) Guide to marking and labelling requirements for
ME equipment and ME systems . 66
201.C.101 Marking on the outside of ME equipment, ME systems or their
parts . 66
201.C.102 Accompanying documents, general . 67
201.C.103 Accompanying documents, instructions for use . 67
201.C.104 Accompanying documents, technical description . 70
Annex D (informative) Symbols on marking . 71
Annex AA (informative) Particular guidance and rationale . 75
AA.1 General guidance. 75
AA.2 Rationale for particular clauses and subclauses . 75
Annex BB (informative) Data interfaces . 114
BB.1 Background and purpose . 114
BB.2 Data definition . 115
Annex CC (informative) Reference to the essential principles . 123
Annex DD (informative) Reference to the general safety and performance
requirements .126
Annex EE (informative) Terminology — Alphabetized index of defined terms . 129
Bibliography .134
vi © ISO 2020 – All rights reserved
ISO 80601-2-12:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
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 ISO documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO 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).
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.
This document was prepared 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, Electrical equipment in medical practice, Subcommittee SC 62D, Electric
equipment, 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 second edition cancels and replaces the first edition (ISO 80601-2-12:2011), which has been
technically revised. It also incorporates the Technical Corrigendum ISO 80601-2-12:2011/Cor 1:2011.
The main changes compared to the previous edition are as follows:
— alignment with IEC 60601-1:2005+AMD1:2012, IEC 60601-1-8:2006+AMD1:2012, IEC
60601-1-2:2014 and IEC 60601-1-6:2010+AMD1:2013.
— determination of probability of component failure during the expected service life;
— delivered gas maximum enthalpy requirement;
— new test protocol for internal electrical power source operation time;
— performance test and disclosure requirements for other inflation-types;
— additional protections against hazardous outputs;
— clarification of performance requirements during abnormals testing;
— consideration of input gas of Oxygen 93 %; and
— harmonization of terminology with ISO 19223, where appropriate.
ISO 80601-2-12:2020(E)
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
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.
viii © ISO 2020 – All rights reserved
ISO 80601-2-12:2020(E)
Introduction
In this document, the following print types are used:
— Requirements and definitions: roman type;
— Instructions, test specifications and terms defined in Clause 3 of the general standard, in this
document or as noted: italic type;
— Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
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.
For the purposes of this document, the auxiliary verb
— “shall” means that conformance with a requirement or a test is mandatory for conformance
with this document,
— “should” means that conformance with a requirement or a test is recommended but is not
mandatory for conformance with this document;
— “may” is used to describe permission (e.g. a permissible way to achieve conformance with a
requirement or test),
— "can" is used to describe a possibility or capability, and
— "must" is used to express an external constraint.
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.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
INTERNATIONAL STANDARD ISO 80601-2-12:2020(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
Clause 1 of the general standard applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012.
201.1.1 * Scope
Replacement:
This document applies to the basic safety and essential performance of a ventilator in combination
with its accessories, hereafter referred to as ME equipment:
intended for use in an environment that provides specialized care for patients whose
conditions can be life-threatening and who can require comprehensive care and constant
monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment.
Ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional
healthcare facility (i.e. be a transit-operable ventilator).
NOTE 3 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 utilize a physiologic closed-loop-control system
unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be
connected to 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 4 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.
ISO 80601-2-12:2020(E)
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, 7.2.13 and 8.4.1.
NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 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 6 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:
ventilators or accessories intended for anaesthetic applications, which are given in
[2]
ISO 80601-2-13 ;
ventilators or accessories intended for the emergency medical services environment, which are
[3] [4]
given in ISO 80601-2-84 , the future replacement for ISO 10651-3 ;
ventilators or accessories intended for ventilator-dependent patients in the home healthcare
[5]
environment, which are given in ISO 80601-2-72:2015 ;
ventilators or accessories intended for home-care ventilatory support devices, which are
[6] [7]
given in ISO 80601-2-79:2018 and ISO 80601-2-80:2018 ;
[9]
obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70 ;
continuous positive airway pressure (CPAP) ME equipment;
high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs),
[63]
which are given in ISO 80601-2-87 ;
NOTE 7 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-
operational modes.
oxygen therapy constant flow ME equipment; and
cuirass or “iron-lung” ventilation equipment.
201.1.2 Object
Replacement:
The object of this document is to establish basic safety and essential performance requirements
for a ventilator and its accessories.
ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.
2 © ISO 2020 – All rights reserved
ISO 80601-2-12:2020(E)
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.
NOTE 1 This document has been prepared to address the relevant essential principles of safety and performance of
ISO 16142-1:2016 as indicated in Annex CC.
NOTE 2 This document has been prepared to address the relevant general safety and performance requirements
of European regulation (EU) 2017/745 as indicated in Annex DD.
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.
IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-8 apply as modified in Clauses 202, 206 and 208
[12] [13]
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 or the collateral
standards.
For brevity, IEC 60601-1:2005+AMD1:2012 is referred to in this particular document as the
general standard. Collateral standards are referred to by their document number.
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 is 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 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 or the applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012 or the
applicable collateral standard is amended as indicated by the text of this document.
ISO 80601-2-12:2020(E)
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 3.147, 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, 203 for
[12]
IEC 60601-1-3 , 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 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 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.
Clause 2 of the general standard applies, except as follows:
Replacement:
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 7010:2019, Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 15223-1:2016, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic
safety and essential performance — Collateral Standard: Electromagnetic disturbances —
Requirements and tests
IEC 60601-1-6:2010+AMD1:2013, Medical electrical equipment — Part 1-6: General requirements
for basic safety and essential performance — Collateral Standard: Usability
IEC 60601-1-8:2006+AMD1:2012, Medical electrical equipment — Part 1-8: General requirements
for basic safety and essential performance — Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62304:2006+AMD1:2015, Medical device software — Software life cycle processes
4 © ISO 2020 – All rights reserved
ISO 80601-2-12:2020(E)
Addition:
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
ISO 5359:2014, 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, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical
gases and vacuum
ISO 8836:2014, Suction catheters for use in the respiratory tract
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
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 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of
medical devices — Part 1: General essential principles and additional specific essential principles
for all non-IVD medical devices and guidance on the selection of standards
ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application
accessories
ISO 17664:2017, Processing of health care products — Information to be provided by the medical
device manufacturer for the processing of medical devices
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare
applications — Part 1: Evaluation and testing within a risk management process
ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics
ISO 80601-2-12:2020(E)
ISO 23328-1:2003, Bre
...
EN ISO 80601-2-12:2020は、医療用電気機器に関する標準であり、特に重要な要件を定めた文書です。この文書は、重篤な状態にある患者に対して使用される人工呼吸器の基本的な安全性と必須性能に関連しています。重篤なケア環境での使用を目的とし、専門的な医療施設での常時モニタリングが必要な患者に対するものであり、その範囲は広範です。 この標準の大きな強みは、重篤なケアにおける人工呼吸器の基本的な性能を確保するための具体的な安全基準を提供している点です。また、医療従事者によって操作され、人工呼吸に依存する患者に必要なさまざまなサポートレベルを提供することに特化しています。特に、関連するアクセサリーが人工呼吸器の基本的な安全性または必須性能に影響を与える場合、それらも対象となるため、包括的な安全性の確保が可能です。 さらに、この文書は危険を軽減するための明確な要件を含んでおり、特に生理的機能に固有の危険はIEC 60601-1:2005の規定に従って扱われます。たとえば、閉ループ制御システムの利用に関する明確な指針があり、必要な場合には生理的患者変数を考慮する重要性を強調しています。 ただし、重篤な呼吸器が緊急医療サービス環境で使用される場合や、自発呼吸を支援するために設計された機器には適用されないため、この標準は適用範囲が明確に定義されています。これにより、特定の使用条件における性能基準の過誤を防ぐことができ、医療現場におけるリスクを軽減します。 全体として、EN ISO 80601-2-12:2020は、重篤なケアを要する患者に対する人工呼吸器の安全性と性能を保証するための必須の標準であり、現代の医療技術において非常に重要な役割を果たしています。この文書は、医療機器の利用状況における安全確保や患者ケアの質向上に寄与するものといえるでしょう。
The EN ISO 80601-2-12:2020 standard provides comprehensive guidelines for the basic safety and essential performance of critical care ventilators, ensuring that these vital medical electrical (ME) equipment operate effectively in high-stakes healthcare environments. This standard specifically targets devices used for patients who are critically ill and may be dependent on artificial ventilation, demonstrating its relevance in a critical care environment where patient safety and reliable performance are paramount. One of the key strengths of this standard is its clear definition of the scope, which includes the intended use of ventilators and their accessories within specialized healthcare settings. The document confirms that it applies to various types of critical care ventilators, including those designed for transport within a professional healthcare facility, further emphasizing its utility in dynamic care environments. The differentiation of ventilator operation modes showcases an understanding of patient needs, ensuring that the standard addresses a wide range of critical scenarios from ventilator-dependent patients to those requiring less support. Moreover, the standard clearly delineates exclusions, such as ventilators for anaesthetic applications and those intended for home healthcare environments. This focus prevents ambiguity, allowing manufacturers and healthcare providers to easily understand the applicable requirements without conflating different categories of ventilatory support. By not covering accessories that do not interact with the ventilator, the standard streamlines compliance protocols and encourages specialization for various applications. The standard also highlights the importance of safety and performance, not only in the context of ME equipment but also concerning the functionality of connected accessories. This ensures a comprehensive approach to risk management in critical care settings, where even minor failures can have significant consequences. In summary, the EN ISO 80601-2-12:2020 standard stands out for its focused scope and clarity regarding the requirements for critical care ventilators. By addressing the essential performance and safety measures required in critical situations, it remains highly relevant for healthcare professionals and manufacturers alike, promoting improved patient outcomes through regulated device performance.
La norme EN ISO 80601-2-12:2020 est un document fondamental qui établit des exigences particulières pour la sécurité de base et la performance essentielle des ventilateurs de soins critiques. Son champ d'application est clairement défini et se concentre sur l'équipement médical essentiel pour des environnements de soins spécialisés, dédiés aux patients aux conditions potentiellement mortelles, nécessitant une surveillance constante et des soins complets dans des établissements de santé professionnels. Parmi ses nombreux points forts, cette norme souligne que les ventilateurs de soins critiques sont des dispositifs considérés comme vitaux pour le maintien de la vie, ce qui en fait un élément crucial des soins intensifs. La distinction entre les ventilateurs destinés à un usage professionnel et ceux utilisés dans un environnement de secours médical est explicitement clarifiée, permettant ainsi une meilleure compréhension de l'utilisation et des exigences spécifiques. Il est également important de noter que la norme s'applique aux accessoires qui peuvent être reliés à un système respiratoire de ventilateur, ce qui complète la prise en charge de la sécurité et de la performance des équipements médicaux (ME) associés. Cela garantit que tout élément ayant un impact potentiel sur la sécurité de base ou la performance du ventilateur est rigoureusement régulé. La norme aborde également les risques inhérents aux fonctions physiologiques des équipements médicaux, bien que ceux-ci ne soient pas couverts par des exigences spécifiques. Cela témoigne de la nécessité de se référer à d'autres documents pertinents, tels que l'IEC 60601-1, pour une compréhension plus approfondie. Enfin, il est précisé que cette norme ne s'applique pas aux ventilateurs utilisés pour des patients non dépendants de la ventilation artificielle, ni à ceux destinés à des applications anesthésiques ou aux services médicaux d'urgence. Cette exclusion permet de concentrer les exigences sur la population ciblée et de garantir que celles-ci sont adaptables aux divers contextes de soins. Dans l'ensemble, la norme EN ISO 80601-2-12:2020 représente un outil essentiel pour les professionnels de la santé, garantissant que les ventilateurs de soins critiques répondent aux exigences nécessaires pour assurer la sécurité et l'efficacité du traitement des patients dans des scénarios de soins d'urgence. Sa pertinence et sa portée en font un document incontournable dans le domaine de l'équipement médical.
EN ISO 80601-2-12:2020 표준은 중환자 치료를 위한 인공 호흡기 및 그 부속품의 기본 안전성과 필수 성능에 대한 특정 요구 사항을 다루고 있습니다. 이 문서는 생명이 위험한 상태에 있는 환자를 위한 전문 의료 환경에서 사용되는 인공 호흡기를 대상으로 하며, 이러한 환경은 중환자 치료 환경으로 정의됩니다. 중환자 치료용 인공 호흡기는 생명 유지 장치로 간주됩니다. 이 표준의 강점은 의료 전문가가 작동하도록 설계된 인공 호흡기에 대한 명확한 지침을 제공한다는 점입니다. 이는 인공 호흡기가 다양한 수준의 인공 환기 지원이 필요한 환자에게 사용될 수 있도록 하고, 특히 인공 호흡기에 연결된 부속품이 호흡기의 기본 안전성이나 성능에 영향을 미칠 수 있는 경우 그에 대한 조치를 명시합니다. 또한, 이 문서에서는 특정 생리학적 환자 변수를 사용하여 환기 치료 설정을 조정하는 생리학적 폐쇄 루프 제어 시스템을 사용하는 중환자 치료용 인공 호흡기는 포함되지 않음을 명시하고 있습니다. 이러한 명확한 기준은 인공 호흡기의 안전성과 신뢰성을 보장하는 데 큰 도움이 됩니다. 한편, 이 표준은 응급 의료 서비스 환경을 위한 인공 호흡기나, 자발적으로 호흡하는 환자에 대한 지원을 목적에 맞춘 장비에는 적용되지 않음을 주의 깊게 언급하고 있습니다. 이러한 측면은 표준의 적용 범위를 명확히 하고, 특정 용도와 환경에 맞는 안전 요구 사항을 보다 세분화시키는 데 기여합니다. 결과적으로, EN ISO 80601-2-12:2020은 중환자 치료 환경에서 인공 호흡기의 안전성과 성능에 대한 중대한 기준을 설정하며, 이는 의료 제공자와 환자의 안전을 보장하는 데 매우 중요합니다.
Die Norm EN ISO 80601-2-12:2020 befasst sich mit der grundlegenden Sicherheit und der wesentlichen Leistung von Beatmungsgeräten, die in kritischen Pflegeumgebungen eingesetzt werden. Ihr Anwendungsbereich ist klar definiert und konzentriert sich auf Beatmungsgeräte, die für Patienten mit potenziell lebensbedrohlichen Zuständen konzipiert sind. Diese Norm hebt die Bedeutung der angemessenen Überwachung und umfassenden Pflege hervor, die in professionellen Gesundheitseinrichtungen gewährleistet werden. Ein wesentlicher Stärke dieser Norm liegt in ihrer umfassenden Berücksichtigung der Zubehörteile, die mit Beatmungsgeräten verbunden sind und deren Eigenschaften die Sicherheit und Leistung dieser Geräte beeinflussen können. Dadurch wird sichergestellt, dass nicht nur das Hauptgerät, sondern auch alle zugehörigen Komponenten den erforderlichen Sicherheitsstandards entsprechen. Die Relevanz der Norm zeigt sich in ihrer Fokussierung auf Fachpersonal, das mit der Bedienung der Beatmungsgeräte betraut ist, und auf die spezifischen Anforderungen von Patienten, die unterschiedliche Unterstützung durch künstliche Beatmung benötigen. Die klare Abgrenzung, dass die Norm nicht für Beatmungsgeräte gilt, die ausschließlich für Patienten gedacht sind, die nicht auf künstliche Beatmung angewiesen sind, sowie für ergänzende Beatmungsgeräte für Patienten, die spontan atmen, ist besonders wichtig, um Missverständnisse über den Anwendungsbereich zu vermeiden. Zusätzlich behandelt die Norm potenzielle Gefahren, die aus der physiologischen Funktion von medizinischen Geräten entstehen, und verweist auf relevante Abschnitte der IEC 60601-1. Diese Verweise erweitern das Verständnis der Sicherheitsanforderungen und stellen eine wichtige Ergänzung zu den spezifischen Anforderungen der Norm dar. Insgesamt ist die EN ISO 80601-2-12:2020 eine essenzielle Norm, die sowohl die Sicherheit als auch die Leistungsfähigkeit von Lebensunterstützungsgerät en in kritischen Pflegeumgebungen gewährleistet und somit einen bedeutenden Beitrag zur Patientensicherheit und zur Qualität der medizinischen Versorgung leistet.
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...