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EN ISO 80601-2-69:2014

(Main)

Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)

Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)

ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft.
ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.

Medizinische elektrische Geräte - Teil 2-69: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO 80601-2-69:2014)

IEC 60601-1:2005+Änderung 1:2012, 1.1 wird ersetzt durch:
Diese besondere Norm legt Anforderungen an die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE eines SAUERSTOFF-KONZENTRATORS zusammen mit dessen ZUBEHÖR fest, nachfolgend als ME-GERÄT bezeichnet, der dafür vorgesehen ist, die Sauerstoffkonzentration des Gases zu erhöhen, das einem einzelnen PATIENTEN zugeführt werden soll. Derartige SAUERSTOFF-KONZENTRATOREN sind typischerweise für den Einsatz bei der MEDIZINISCHEN VERSORGUNG in HÄUSLICHER UMGEBUNG vorgesehen, einschließlich der Verwendung durch einen einzelnen PATIENTEN bei Bewegung (BETRIEBSFÄHIG BEI BEWEGUNG) in verschiedenen Umgebungen, wie privater und öffentlicher Transport, sowie zur Verwendung in Verkehrsflugzeugen.
ANMERKUNG 1   Ein solcher SAUERSTOFF-KONZENTRATOR kann auch in professionellen Einrichtungen zur Gesundheitsfürsorge angewendet werden.
Diese besondere Norm gilt für BEI BEWEGUNG BETRIEBSFÄHIGE und BEI BEWEGUNG nicht BETRIEBSFÄHIGE SAUERSTOFF-KONZENTRATOREN. Diese besondere Norm ist auf einen SAUERSTOFF-KONZENTRATOR anwendbar, der in andere medizinische Geräte, ME-GERÄTE oder in ME-SYSTEME eingebaut ist oder zusammen mit diesen benutzt wird.
BEISPIEL 1   Ein SAUERSTOFF-KONZENTRATOR mit eingebauter SAUERSTOFF-DOSIEREINRICHTUNG [10] oder mit Anfeuchter [4].
BEISPIEL 2   Ein SAUERSTOFF-KONZENTRATOR in Verwendung mit einem Durchflussmesser.
BEISPIEL 3   Ein SAUERSTOFF-KONZENTRATOR als Teil eines Anästhesiesystems zur Verwendung in Gebieten mit eingeschränkter Bereitstellung von Strom und Anästhesiegasen [3].
BEISPIEL 4   Ein SAUERSTOFF-KONZENTRATOR mit eingebautem Flüssigkeitsreservoir oder Gasflaschenfüllsystem.
Diese besondere Norm gilt auch für jenes ZUBEHÖR, das vom HERSTELLER des ZUBEHÖRS für den Anschluss an einen SAUERSTOFF-KONZENTRATOR vorgesehen ist, wenn die Eigenschaften dieses ZUBEHÖRS die BASISSICHERHEIT oder die WESENTLICHEN LEISTUNGSMERKMALE des SAUERSTOFF-KONZENTRATORS beeinträchtigen können.
Diese besondere Norm legt nicht die Anforderungen an SAUERSTOFF-KONZENTRATOREN zur Verwendung mit einem ROHRLEITUNGSSYSTEM FÜR MEDIZINISCHE GASE fest, die ISO 10083 zu entnehmen sind.
Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf ME-GERÄTE oder ME-SYSTEME vorgesehen, ist das aus der Überschrift und dem Inhalt des Abschnitts oder Unterabschnitts ersichtlich. Ist das nicht der Fall, trifft gegebenenfalls der Abschnitt oder Unterabschnitt auf das ME-GERÄT und das ME SYSTEM zu.
Die mit der physiologischen Funktion des ME-GERÄTS oder ME-SYSTEMS innerhalb des Anwendungsbereiches dieser Norm direkt verbundenen GEFÄHRDUNGEN werden nicht in spezifischen Anforderungen dieser Norm berücksichtigt, mit Ausnahme von 7.2.13 und 8.4.1 der allgemeinen Norm.
ANMERKUNG 2   Siehe auch 4.2 der allgemeinen Norm.
Diese Internationale Norm ist eine besondere Norm in der IEC 60601-1-Normenreihe.

Appareils électromédicaux - Partie 2-69: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO 80601-2-69:2014)

L'ISO 80601-2-69:2014 spécifie les exigences applicables à la sécurité de base et aux performances essentielles d'un concentrateur d'oxygène en combinaison avec ses accessoires, désigné ci-après sous le terme d'appareil em, visant à augmenter la concentration en oxygène du gaz destiné à être délivré à un patient unique. De tels concentrateurs d'oxygène sont, en général, destinés à être utilisés dans un environnement de soins à domicile, et sont également opérationnels en déplacement pour un patient unique dans divers environnements, dans les transports publics et privés ainsi que dans les transports aériens.
L'ISO 80601-2-69:2014 est applicable aux concentrateurs d'oxygène opérationnels en déplacement et non opérationnels en déplacement. Elle est applicable aux concentrateurs d'oxygène intégrés ou utilisés avec d'autres dispositifs médicaux, appareils em ou systèmes em.

Medicinska električna oprema - 2-69. del: Posebne zahteve za osnovno varnost in bistvene lastnosti naprav za koncentriranje kisika (ISO 80601-2-69:2014)

Standard EN ISO 80601-2-69 določa zahteve za OSNOVNO VARNOST in BISTVENE LASTNOSTI NAPRAV ZA KONCENTRIRANJE KISIKA v kombinaciji s PRIPOMOČKI, v nadaljevanju MEDICINSKI PRIPOMOČKI, ki so namenjeni za povečanje koncentracije kisika v plinu, ki ga prejema PACIENT. Takšne NAPRAVE ZA KONCENTRIRANJE KISIKA se običajno uporabljajo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE, vključno z DELOVANJEM MED NOŠNJO s strani PACIENTA v različnih okoljih, tako v osebnih in javnih prevozih ter komercialnih prevozih, kot so letala.

General Information

Status
Withdrawn
Publication Date
15-Jul-2014
Withdrawal Date
17-Nov-2020
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 2 - Lung ventilators
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
18-Nov-2020
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 80601-2-69:2014 - Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)

Relations

Replaces
EN ISO 8359:2009/A1:2012 - Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)
Effective Date
23-Jul-2014
Replaces
EN ISO 8359:2009 - Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
Effective Date
23-Jul-2014
Replaced By
EN ISO 80601-2-69:2020 - Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
Effective Date
08-Jun-2022

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Standards Content (Sample)


SLOVENSKI STANDARD
01-oktober-2014
1DGRPHãþD
SIST EN ISO 8359:2009
SIST EN ISO 8359:2009/A1:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLQDSUDY]DNRQFHQWULUDQMHNLVLND ,62
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and
essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO
80601-2-69:2014)
Appareils électromédicaux - Partie 2-63 : exigences particulières pour la sécurité de
base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO
80601-2-69:2014)
Ta slovenski standard je istoveten z: EN ISO 80601-2-69:2014
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.

EUROPEAN STANDARD
EN ISO 80601-2-69
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.040.10 Supersedes EN ISO 8359:2009
English Version
Medical electrical equipment - Part 2-69: Particular requirements
for basic safety and essential performance of oxygen
concentrator equipment (ISO 80601-2-69:2014)
Appareils électromédicaux - Partie 2-69: Exigences Medizinische elektrische Geräte - Teil 2-69: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des dispositifs concentrateurs d'oxygène (ISO wesentlichen Leistungsmerkmale für Sauerstoff-
80601-2-69:2014) Konzentratoren (ISO 80601-2-69:2014)
This European Standard was approved by CEN on 28 May 2014.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-69:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC .4

Foreword
This document (EN ISO 80601-2-69:2014) 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 January 2015, and conflicting national standards shall be withdrawn at
the latest by July 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8359:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-69:2014 has been approved by CEN as EN ISO 80601-2-69:2014 without any
modification.
Annex ZA
(informative)
Relationship between this Document and
the Essential Requirements of EU Directive 93/42/EEC
This Document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the
Member States concerning medical devices” (Medical Device Directive).
Once this document is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.11.6.4, 201.11.6.6 7.2 Only the parts of ER 7.2 relating to
safety in use for the PATIENT are
addressed.
201.11.6.4, 201.11.6.6 7.3 Only the part of the first sentence
of ER 7.3 relating to design is
addressed.
201.11.6.4 7.5
201.11 7.6
201.11.6.6, 201.11.6.7 8.1 The part of ER 8.1 relating to easy
handling is not addressed.
201.11.6.7 8.4 Validated processes for
sterilization are required via the
normative references to
ISO 11135-1, ISO 11137-1 and
ISO 17665-1.
201.4.6, 201.7.2.4.101, 9.1
201.7.2.13.101, 201.7.2.17.101,
201.7.2.101, 201.7.9.2.2.101,
201.7.9.2.5.101, 201.7.9.2.14.101,
201.12.1.101, 201.12.1.102,
201.12.1.103, 201.16, 201.101,
201.102
201.9, 202, 206, 211 9.2 The 4th indent of ER 9.2 is not
addressed.
201.11 9.3
201.12.1, 201.102 10.1 The part of ER 10.1 relating to
stability is not addressed.
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.7, 201.12.1, 206, 208 10.2
201.7.4.3 10.3
201.14 12.1
201.14 12.1 a)
202 12.5
201.8 12.6
201.9, 211 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.101, 201.15, 201.103 12.7.4
201.11 12.7.5
201.12.1 12.8.1 Only the protection of the PATIENT
is covered.
201.12.4 12.8.2 Only the first sentence of ER

12.8.2 is covered.
201.7, 206 12.9
201.7, 201.11.6.4 13.1
201.7.2.1, 201.7.2.13.101, 13.2
201.7.2.17.101, 201.7.2.101,
201.8, 201.9, 201.11.6.4
201.7.9.1 13.3 a)
201.7.2.17.101 13.3 b)
201.7, 201.7.2.17.101 a) 13.3 c)
201.7.2.17.101 13.3 d) Is only covered if the batch number
is preceded by the word LOT.
201.7.2.17.101 13.3 f)
201.7.2.101 a), 211 13.3 i)
201.7.2.101 b), 201.7.2.101 d), 211 13.3 j)
201.7.2.101 b) 13.3 k)
201.7, 201.7.2.17.101 a) 13.3 m) Presumption of conformity is only
provided if one of the symbols 5.21
to 5.24 from ISO 15223-1:2012 are

utilized, as applicable.
201.7.9.1, 201.7.9.2, 201.16 13.6 a)
201.7.9.2.5.101 13.6 b)
201.7.9.2.14.101, 201.16, 201.102 13.6 c)
201.7, 201.7.9.2.8.101, 13.6 d)
201.7.9.2.13.101, 201.16
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.16 13.6 f)
201.7.9.2.1.101, 201.7.9.2.12, 13.6 h)
201.16, 211
201.7 13.6 i)
211 13.6 k)
211 13.6 k)
211 13.6 l)
211 13.6 n)
201.12.1.103, 211 13.6 p)
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this European Standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant
essential health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are
more specific than essential requirements of Directive 93/42/EEC along with the corresponding clauses of this
European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery
directive and thus does not provide presumption of conformity for the machinery directive.
Table ZA.2 — Relevant Essential Requirements from Directive 2006/42/EC on machinery that are
addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) EHSR of 2006/42/EC Qualifying remarks/Notes
of this EN
— 1.1.4 This relevant EHSR is not
covered by this European
Standard.
201.12.1, 201.12.101 1.2.2
201.7.2.101 c), 201.7.2.101 d), 1.5.4
201.101
— 1.6.2 This relevant EHSR is not
covered by this European
Standard.
201.8 1.6.3
INTERNATIONAL ISO
STANDARD 80601-2-69
First edition
2014-07-15
Medical electrical equipment —
Part 2-69:
Particular requirements for basic safety
and essential performance of oxygen
concentrator equipment
Appareils électromédicaux —
Partie 2-69: Exigences particulières pour la sécurité de base et
les performances essentielles des dispositifs concentrateurs
d'oxygène
Reference number
ISO 80601-2-69:2014(E)
©
ISO 2014
ISO 80601-2-69:2014(E)
©  ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii
ISO 80601-2-69:2014(E)
Contents Page
Foreword . 5
Introduction . 7
201.1 Scope, object and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 5
201.5 General requirements for testing of ME EQUIPMENT . 6
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 6
201.7 ME EQUIPMENT identification, marking and documents . 6
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16
201.13 HAZARDOUS SITUATIONS and fault conditions . 20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 20
201.15 Construction of ME EQUIPMENT . 20
201.16 ME SYSTEMS . 20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
201.101 Outlet connector . 21
201.102 Requirements for parts and ACCESSORIES . 21
201.102.1  * General .
...

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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

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EN ISO 80601-2-84:2023(Main)
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023)
SIST EN ISO 80601-2-84:2024

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
¾     intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
¾     intended to be operated by a healthcare professional operator;
¾     intended for use in the EMS environment; and
¾     intended for invasive or non-invasive ventilation.
NOTE 2     An EMS ventilator can also be used for transport within a professional healthcare facility.
An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the  artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 3     If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4     Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for the following:
NOTE 5     See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 
¾     ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
¾     ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72.
¾     ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
¾     ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80.
¾     obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70.
¾     user-powered resuscitators, which are given in ISO 10651‐4.
¾     gas-powered emergency resuscitators, which are given in ISO 10651‐5.
¾     continuous positive airway pressure (CPAP) ME equipment.
¾     high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87.
¾     high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87.
NOTE 6      An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
¾     respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.
NOTE 7      An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
¾     oxygen therapy constant flow ME equipment.
¾     cuirass or “iron‐lung” ventilators.

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EN ISO 10524-1:2019/A1:2023(Amendment)
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1 (ISO 10524-1:2018/Amd 1:2023)
SIST EN ISO 10524-1:2019/A1:2024
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EN ISO 5367:2023(Main)
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
SIST EN ISO 5367:2023

This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.
This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.

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EN ISO 27427:2023(Main)
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
SIST EN ISO 27427:2023

This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.
This document includes gas-powered nebulizers (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and electrically powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers. This document does not specify the electrical requirements of electrically powered nebulizers.
This document does not specify the minimum performance of nebulizing systems.
This document does not apply to:
a)       devices intended for nasal deposition;
b)       devices intended solely to provide humidification or hydration by providing water in aerosol form.
NOTE 1        ISO 80601-2-74 and ISO 20789 cover these devices.
c)        drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).
NOTE 2        ISO 20072 covers these devices.
NOTE 3        See Annex A for rationale.

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EN ISO 80601-2-72:2023(Main)
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023)
SIST EN ISO 80601-2-72:2023

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 the home healthcare environment;
—    intended for use by a lay operator; and
—    intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
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.

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EN ISO 10651-4:2023(Main)
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)
SIST EN ISO 10651-4:2023

This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range.
Example user-powered resuscitators include:
—    self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and
NOTE 1    Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations.
—    flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source.
This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator.
Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.
This document is also applicable to point-of-use packaging.
This document does not specify the requirements for:
—    gas-powered emergency resuscitators, which are given in ISO 10651-5;
—    electrically-powered resuscitators;
—    gas powered resuscitators for professional healthcare facilities; and
—    anaesthetic reservoir bags, which are given in ISO 5362.
NOTE 2    This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
NOTE 3    This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E.
NOTE 4    This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.

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