EN ISO 80601-2-74:2021
(Main)Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021)
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021)
This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.
This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers).
NOTE 1 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1.
NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes.
This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.
NOTE 3 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.
EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12[10] also applies.
EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2-72[12] also applies.
EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70[11] also applies.
EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79[13] or ISO 80601-2-80[14] also apply.
EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90[15] also applies.
This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.
NOTE 4 ISO 9360‑1 and ISO 9360‑2[4] specify safety and performance requirements for a passive HME.
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 does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789[6].
This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.
This
Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen für Atemgase (ISO 80601-2-74:2021)
Dieses Dokument ist anzuwenden für die Basissicherheit und die wesentlichen Leistungsmerkmale eines Anfeuchters, nachfolgend auch als ME Gerät bezeichnet, in Kombination mit dem entsprechenden Zubehör, wobei die Kombination nachfolgend auch als ME System bezeichnet wird.
Dieses Dokument ist auch anzuwenden für Zubehör, für das der Hersteller den Anschluss an einen Anfeuchter vorsieht, bei dem die Merkmale dieses Zubehörs die Basissicherheit oder die wesentlichen Leistungsmerkmale des Anfeuchters beeinflussen können.
BEISPIEL 1 Beheizte Atemschläuche (Atemschläuche mit Heizdrähten) oder ME Geräte, die zur Regelung dieser beheizten Atemschläuche vorgesehen sind (Regelvorrichtungen für beheizte Atemschläuche).
ANMERKUNG 1 Beheizte Atemschläuche und ihre Regelvorrichtungen sind ME Geräte und unterliegen den Anforderungen von IEC 60601-1.
ANMERKUNG 2 ISO 5367 legt weitere sicherheitstechnische und Leistungsanforderungen an Atemschläuche fest.
Dieses Dokument enthält Anforderungen an die verschiedenen medizinischen Einsatzmöglichkeiten der Anfeuchtung wie beispielsweise invasive und nicht-invasive Beatmung, Nasal-High-Flow-Therapie, Therapie der obstruktiven Schlafapnoe sowie die Anfeuchtungstherapie für tracheostomierte Patienten.
ANMERKUNG 3 Ein Anfeuchter kann in andere Geräte integriert sein. Ist dies der Fall, gelten die Anforderungen an die anderen Geräte auch für den Anfeuchter.
BEISPIEL 2 Beheizte Anfeuchter, die in Beatmungsgeräte für die Intensivpflege integriert sind; in diesem Fall gilt auch ISO 80601-2-12[10].
BEISPIEL 3 Beheizte Anfeuchter, die in Heimbeatmungsgeräte für vom Gerät abhängige Patienten integriert sind; in diesem Fall gilt auch ISO 80601-2-72 [12].
BEISPIEL 4 Beheizte Anfeuchter, die in Schlafapnoe-Atemtherapiegeräte integriert sind; in diesem Fall gilt auch ISO 80601-2-70 [11].
BEISPIEL 5 Beheizte Anfeuchter, die in Heimbeatmungsgeräte zur Atemunterstützung integriert sind; in diesem Fall gilt auch ISO 80601-2-79[13] oder ISO 80601-2-80[14].
BEISPIEL 6 Beheizte Anfeuchter, die in High-Flow-Atemtherapiegeräte integriert sind; in diesem Fall gilt auch ISO 80601-2-90 [15].
Dieses Dokument enthält auch Anforderungen an aktive HME (Wärme- und Feuchtigkeitsaustauscher, en: heat and moisture exchangers), ME Geräte, die aktiv Wärme und Feuchtigkeit zuführen, um den Feuchtigkeitsgrad des vom HME an den Patienten abgegebenen Gases zu erhöhen. Dieses Dokument ist nicht anzuwenden für passive HME, die während der Einatmung einen Teil der vom Patienten ausgeatmeten Feuchtigkeit und Wärme ohne Zusatz von Wärme und Feuchtigkeit in den Atemtrakt zurückführen.
ANMERKUNG 4 ISO 9360-1 und ISO 9360-2[4] legen Sicherheits- und Leistungsanforderungen an passive HME fest.
ANMERKUNG 5 Ist ein Abschnitt oder Unterabschnitt speziell für die Anwendung nur auf ME Geräten oder nur auf ME Systemen vorgesehen, ist dies aus Überschrift und Inhalt des Abschnitts oder Unterabschnitts ersichtlich. In den übrigen Fällen gilt der Abschnitt oder Unterabschnitt je nach Zutreffen für sowohl ME Geräte als auch ME Systeme.
Gefährdungen, die der vorgesehenen physiologischen Funktion der in den Anwendungsbereich dieses Dokuments fallenden ME Geräte oder ME Systeme inhärent sind, werden nicht durch die spezifischen Anforderungen dieser Norm abgedeckt, ausgenommen sind IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 und 8.4.1.
[...]
Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base et les performances essentielles des équipements d'humidification respiratoire (ISO 80601-2-74:2021)
Le présent document s'applique à la sécurité de base et aux performances essentielles d'un humidificateur, ci-après également désigné par appareil EM, associé à ses accessoires, dont la combinaison est ci-après désignée par système EM.
Le présent document s'applique également aux accessoires conçus par leur fabricant pour être raccordés à un humidificateur, du fait que les caractéristiques de ces accessoires peuvent avoir un impact sur la sécurité de base ou sur les performances essentielles de l'humidificateur.
EXEMPLE 1 Tuyaux respiratoires chauffés (tuyaux respiratoires avec résistance chauffante) ou les appareils EM destinés à commander ces tuyaux respiratoires chauffés (commandes de tuyaux respiratoires chauffés).
NOTE 1 Les tuyaux respiratoires chauffés et leurs commandes sont des appareils EM et sont soumis aux exigences de l'IEC 60601‑1.
NOTE 2 L'ISO 5367 spécifie d'autres exigences de sécurité et de performance pour les tuyaux respiratoires.
Le présent document contient des exigences pour les différentes utilisations médicales de l'humidification, telles que la ventilation invasive, la ventilation non invasive, l'oxygénothérapie nasale à haut débit et le traitement de l'apnée obstructive du sommeil, ainsi que l'humidification pour les patients trachéotomisés.
NOTE 3 Un humidificateur peut être intégré dans un autre appareil. Dans ce cas, les exigences de l'autre appareil s'appliquent aussi à l'humidificateur.
EXEMPLE 2 Humidificateur chauffé intégré dans un ventilateur pulmonaire pour utilisation en soins intensifs où l'ISO 80601‑2-12[10] s'applique aussi.
EXEMPLE 3 Humidificateur chauffé intégré dans un ventilateur utilisé dans l'environnement des soins à domicile pour les patients dépendants où l'ISO 80601‑2-72[12] s'applique aussi.
EXEMPLE 4 Humidificateur chauffé intégré dans du matériel de traitement respiratoire de l'apnée du sommeil où l'ISO 80601‑2‑70[11] s'applique aussi.
EXEMPLE 5 Humidificateur chauffé intégré dans l’équipement d’assistance ventilatoire où l’ISO 80601-2-79[13] ou l’ISO 80601-2-80[14] s’applique aussi.
EXEMPLE 6 Humidificateur chauffé intégré dans du matériel d'oxygénothérapie à haut débit où l'ISO 80601‑2‑90[15] s'applique aussi.
Le présent document contient également des exigences pour les ECH actifs (échangeurs de chaleur et d'humidité), appareils EM qui ajoutent activement de la chaleur et de l'humidité afin d'augmenter le niveau d'humidité du gaz administré au patient par l'ECH. Le présent document ne s'applique pas aux ECH passifs qui renvoient une partie de l'humidité et de la chaleur de l'air expiré par le patient aux voies respiratoires lors de l'inspiration, sans ajout de chaleur ou d'humidité.
NOTE 4 L’ISO 9360‑1 et l’ISO 9360‑2[4] spécifient les exigences de sécurité et de performances pour un ECH passif.
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. Dans le cas contraire, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de l'IEC 60601‑1:2005+AMD1
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2021)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2021
Nadomešča:
SIST EN ISO 80601-2-74:2020
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2021)
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and
essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021)
Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen für
Atemgase (ISO 80601-2-74:2021)
Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements d'humidification respiratoire (ISO
80601-2-74:2021)
Ta slovenski standard je istoveten z: EN ISO 80601-2-74:2021
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 80601-2-74
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-74:2020
English Version
Medical electrical equipment - Part 2-74: Particular
requirements for basic safety and essential performance of
respiratory humidifying equipment (ISO 80601-2-
74:2021)
Appareils électromédicaux - Partie 2-74: Exigences Medizinische elektrische Geräte - Teil 2-74: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles des équipements wesentlichen Leistungsmerkmale von
d'humidification respiratoire (ISO 80601-2-74:2021) Anfeuchtersystemen für Atemgase (ISO 80601-2-
74:2021)
This European Standard was approved by CEN on 2 July 2021.
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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-74:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-74:2021) 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 2022, and conflicting national standards shall
be withdrawn at the latest by January 2022.
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 80601-2-74:2020.
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 websites.
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 80601-2-74:2021 has been approved by CEN as EN ISO 80601-2-74:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-74
Second edition
2021-07
Medical electrical equipment —
Part 2-74:
Particular requirements for basic
safety and essential performance of
respiratory humidifying equipment
Appareils électromédicaux —
Partie 2-74: Exigences particulières pour la sécurité de base et
les performances essentielles des équipements d'humidification
respiratoire
Reference number
ISO 80601-2-74:2021(E)
©
ISO 2021
ISO 80601-2-74:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2021 – All rights reserved
ISO 80601-2-74:2021(E)
Contents Page
Foreword . v
Introduction . vii
201.1 Scope, object and related standards. 1
201.2 Normative references . 3
201.3 Terms and definitions . 5
201.4 General requirements . 8
201.5 General requirements for testing of ME equipment . 11
201.6 Classification of ME equipment and ME systems . 12
201.7 ME equipment identification, marking and documents . 13
201.8 Protection against electrical hazards form ME equipment . 20
201.9 Protection against mechanical hazards of ME equipment and ME systems. 20
201.10 Protection against unwanted and excessive radiation hazards . 21
201.11 Protection against excessive temperatures and other hazards . 21
201.12 Accuracy of controls and instruments and protection against hazardous outputs
.......................................................................................................................................................... 24
201.13 Hazardous situations and fault conditions for ME Equipment . 30
201.14 Programmable electrical medical systems (PEMS) . 31
201.15 Construction of ME equipment . 32
201.16 ME systems . 32
201.16.2 Accompanying documents of an ME system . 32
201.17 Electromagnetic compatibility of ME equipment and ME systems . 32
201.101 Breathing system connectors and ports . 33
201.102 Requirements for the breathing system and accessories . 35
201.103 Liquid container . 36
201.104 Functional connection . 36
202 Electromagnetic disturbances — Requirements and tests . 37
206 Usability . 38
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 39
211 Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment . 39
Annex C (informative) Guide to marking and labelling requirements for ME equipment
and ME systems . 40
Annex D (informative) Symbols on marking . 45
Annex AA (informative) Particular guidance and rationale . 47
Annex BB (normative) * Determination of the accuracy of the displayed measured gas
temperature . 64
Annex CC (normative) * Determination of the humidification output . 66
Annex DD (normative) * Specific enthalpy calculations . 71
Annex EE (normative) Removable temperature sensors and mating ports . 73
Annex FF (normative) * Reference temperature sensor . 77
ISO 80601-2-74:2021(E)
Annex GG (informative) Saturation vapour pressure . 80
Annex HH (informative) Reference to the IMDRF essential principles and labelling
guidances . 81
Annex II (informative) Reference to the essential principles of safety and performance of
medical devices in accordance with ISO 16142-1:2016 . 85
Annex JJ (informative) Reference to the general safety and performance requirements
.......................................................................................................................................................... 88
Annex KK (informative) Terminology — Alphabetized index of defined terms . 91
Bibliography . 95
iv
ISO 80601-2-74:2021(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
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