EN ISO 80601-2-12:2023
(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
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,
...
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