FprEN ISO 80601-2-90
(Main)Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO/FDIS 80601-2-90:2021)
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO/FDIS 80601-2-90:2021)
This document applies to the basic safety and essential performance of ventilatory high-flow therapy equipment, as defined in 201.3.204, hereafter also referred to as ME equipment, in combination with its accessories:
- intended for use in the home healthcare environment;
- intended for use in professional healthcare facilities;
- intended for use by a lay operator or a healthcare professional operator;
- intended for use with patients who can breathe spontaneously;
- intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, including a patient whose upper airway is bypassed; and
EXAMPLE 1 Patients with Type 1 Respiratory Failure, which exhibits a reduction in arterial blood oxygenation or patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
- not intended for patients who are dependent on artificial ventilation for their life support.
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
Ventilatory high-flow therapy equipment is typically composed of four parts:
1) gas sources,
- air, and
- if needed, oxygen;
NOTE 2 Gas sources include medical gas pipeline systems, gas cylinders, oxygen concentrators and ambient air.
2) humidifier;
NOTE 3 When dry gas is utilized, a humidifier is typically needed.
3) breathing tube;
4) a patient interface, which is used to deliver gas to the patient; and
5) a flow controller, which is used to select and deliver the desired flow.
NOTE 4 The flow controller can be at a fixed rate.
NOTE 5 The flowrate range is dependent upon the intended patient population (e.g., neonatal, paediatric and adult patients can require different flowrates).
These parts can be combined (e.g., the gas source and humidifier can be combined). Ventilatory highflow therapy equipment interfaces with the patient whose upper airway is intact via a nasal cannula or mask as well as a patient whose upper airway is bypassed via an endotracheal tube, oropharyngeal mask, or tracheostomy.
Ventilatory high-flow therapy equipment can be transit-operable.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilatory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory high-flow therapy equipment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
This document does not specify the requirements for:
- ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601 2 12;
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601 2 13;
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601 2 84;
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601 2 72;
- ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601 2 79;
- ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601 2 80;
- 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);
- high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601 2 87; and
- cuirass or "iron-lung" ventilation equipment.
NOTE 4 Ventilatory high-flow therapy equipment can be incorporated into any of the above equipment, in which case those standards would be applicable for those ventilation-modes.
This docum.....
Medizinische elektrische Geräte - Teil 2-90: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Geräten für die Beatmungstherapie mit hohem Durchfluss (ISO/FDIS 80601-2-90:2021)
Dieses Dokument gilt für die Basissicherheit und die wesentlichen Leistungsmerkmale von Atemtherapiegeräten mit hohem Durchfluss, wie in 201.3.220 definiert, im Folgenden auch als ME Geräte oder ME Systeme bezeichnet, in Kombination mit ihrem Zubehör:
- die für die Verwendung bei Patienten, die spontan atmen können bestimmt sind; und
- die für Patienten bestimmt sind, die von einem verbesserten alveolären Gasaustausch profitieren würden; und die davon profitieren würden, befeuchtete Atemgase mit hohem Durchfluss zu erhalten, was einen Patienten, dessen obere Atemwege umgangen werden, beinhalten kann.
BEISPIEL 1 Patienten mit Typ 1-Atmungsinsuffizienz, die eine Verminderung der Oxygenierung arteriellen Bluts aufweisen.
BEISPIEL 2 Patienten, die von einer verminderten Atemarbeit profitieren würden, wie sie bei Typ 2-Atmungsinsuffizienz mit hohem arteriellem Kohlendioxid erforderlich ist.
BEISPIEL 3 Patienten, die eine Anfeuchtung zur Verbesserung der mukoziliären Reinigung benötigen.
Atemtherapiegeräte mit hohem Durchfluss können für die medizinische Versorgung in häuslicher Umgebung oder in professionellen Gesundheitseinrichtungen vorgesehen sein.
ANMERKUNG 1 Bei der medizinischen Versorgung in häuslicher Umgebung ist das Versorgungsnetz oft nicht zuverlässig.
Atemtherapiegeräte mit hohem Durchfluss können sein:
- voll integrierte ME Geräte; oder
- eine Kombination aus separaten Elementen, die ein ME System bilden.
Diese Norm gilt auch für andere Typen von Atemgeräten, wenn diese Geräte eine Betriebsart für Atemtherapie mit hohem Durchfluss aufweisen.
ANMERKUNG 2 Diese Norm und ISO 80601 2 12[14] gelten für ein Intensivpflege-Beatmungsgerät mit einer Betriebsart für Therapie mit hohem Durchfluss.
Atemtherapiegeräte mit hohem Durchfluss können betriebsfähig bei Bewegung sein.
Dieses Dokument gilt auch für Zubehör, das durch den Hersteller für den Anschluss an Atemtherapiegeräte mit hohem Durchfluss vorgesehen ist, sofern die Merkmale dieses Zubehörs die Basissicherheit oder die wesentlichen Leistungsmerkmale der Atemtherapiegeräte mit hohem Durchfluss beeinflussen können.
BEISPIEL 4 Atemsets, Verbindungsstücke, Anfeuchter, Atemsystemfilter, externe elektrische Spannungsquelle, verteiltes Alarmsystem, Nasenbrille mit hohem Durchfluss, Trachealtubus, Tracheotomietubus, Gesichts-Maske und supra-laryngealer Luftweg.
Wenn ein Abschnitt oder Unterabschnitt speziell nur auf ME Geräte oder ME Systeme angewendet werden soll, wird dies aus der Überschrift und dem Inhalt des jeweiligen Abschnitts oder Unterabschnitts deutlich. Ist dies nicht der Fall, gilt der Abschnitt oder Unterabschnitt, je nach Zutreffen, für das ME Gerät und das ME System.
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 in diesem Dokument abgedeckt, ausgenommen in der Allgemeinen Norm, 7.2.13 und 8.4.1.
ANMERKUNG 3 Zusätzliche Informationen sind in der Allgemeinen Norm, 4.2, zu finden.
[...]
Appareils électromédicaux - Partie 2-90: Exigences particulières pour la sécurité de base et les performances essentielles des équipements de thérapie respiratoire à haut débit (ISO/FDIS 80601-2-90:2021)
Medicinska električna oprema - 2-90. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za respiratorno terapijo z velikim pretokom (ISO/FDIS 80601-2-90:2021)
General Information
Standards Content (sample)
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-90:2020
01-december-2020
Medicinska električna oprema - 2-90. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za respiratorno terapijo z velikim pretokom (ISO/DIS
80601-2-90:2020)
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and
essential performance of ventilatory high-flow therapy equipment (ISO/DIS 80601-2-
90:2020)Medizinische elektrische Geräte - Teil 2-90: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Geräten für die Beatmungstherapie mithohem Durchfluss (ISO/DIS 80601-2-90:2020)
Appareils électromédicaux - Partie 2-90: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements de thérapie respiratoire à haut débit
(ISO/DIS 80601-2-90:2020)Ta slovenski standard je istoveten z: prEN ISO 80601-2-90
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-90:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80601-2-90:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-90
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-10-07 2020-12-30
Medical electrical equipment —
Part 2-90:
Particular requirements for basic safety and essential
performance of ventilatory high-flow therapy equipment
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-90:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 80601-2-90:2020
ISO 80601-2-90:2020(E)
ISO/DIS 80601-2-90:2020(E)
1 Contents
2 Contents ........................................................................................................................................................................... iii
3 Introduction ................................................................................................................................................................... vi
4 201.1 Scope, object and related standards ........................................................................................................ 1
5 201.2 Normative references .................................................................................................................................... 3
6 201.3 Terms and definitions ................................................................................................................................... 5
7 201.4 General requirements ................................................................................................................................... 9
8 201.5 General requirements for testing of ME equipment ......................................................................... 11
9 201.6 Classification of ME equipment and ME systems ................................................................................. 11
10 201.7 ME equipment identification, marking and documents................................................................... 11
11 201.8 Protection against electrical hazards from ME equipment ............................................................ 18
12 201.9 Protection against mechanical hazards of ME equipment and ME systems .............................. 18
13 201.10 Protection against unwanted and excessive radiation hazards .................................................. 20
14 201.11 Protection against excessive temperatures and other hazards ................................................... 20
15 201.12 Accuracy of controls and instruments and protection against hazardous outputs .............. 23
16 201.13 Hazardous situations and fault conditions for ME equipment ...................................................... 30
17 201.14 Programmable electrical medical systems (PEMS) ............................................................................ 31
18 201.15 Construction of ME equipment ................................................................................................................. 31
19 201.16 ME systems ....................................................................................................................................................... 32
20 201.17 Electromagnetic compatibility of ME equipment and ME systems ............................................... 32
21 201.101 Gas connections ..................................................................................................................................... 33
22 201.102 Requirements for the breathing system and accessories ....................................................... 35
23 201.103 * Indication of duration of operation ............................................................................................ 36
24 201.104 Functional connection .......................................................................................................................... 37
25 201.105 Power supply cords ............................................................................................................................... 37
26 201.106 Respiratory high-flow therapy equipment security .................................................................. 37
27 202 Electromagnetic disturbances — Requirements and tests ............................................................ 38
28 206 Usability ........................................................................................................................................................... 38
29 208 General requirements, tests and guidance for alarm systems in medical electrical
30 equipment and medical electrical systems ......................................................................................... 40
31 211 Requirements for medical electrical equipment and medical electrical systems
32 used in the home healthcare environment ......................................................................................... 42
33 Annex C (informative) Guide to marking and labelling requirements for ME equipment and
COPYRIGHT PROTECTED DOCUMENT34 ME systems ....................................................................................................................................................... 43
© ISO 202035 Annex D (informative) Symbols on marking .................................................................................................... 49
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
36 Annex AA (informative) Particular guidance and rationale ....................................................................... 50
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. 37 Annex BB (informative) Data interface requirements ................................................................................. 63
ISO copyright officeCP 401 • Ch. de Blandonnet 8
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© ISO 2020 – All rights reserved iii
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 80601-2-90:2020
ISO 80601-2-90:2020(E)
1 Contents
2 Contents ........................................................................................................................................................................... iii
3 Introduction ................................................................................................................................................................... vi
4 201.1 Scope, object and related standards ........................................................................................................ 1
5 201.2 Normative references .................................................................................................................................... 3
6 201.3 Terms and definitions ................................................................................................................................... 5
7 201.4 General requirements ................................................................................................................................... 9
8 201.5 General requirements for testing of ME equipment ......................................................................... 11
9 201.6 Classification of ME equipment and ME systems ................................................................................. 11
10 201.7 ME equipment identification, marking and documents................................................................... 11
11 201.8 Protection against electrical hazards from ME equipment ............................................................ 18
12 201.9 Protection against mechanical hazards of ME equipment and ME systems .............................. 18
13 201.10 Protection against unwanted and excessive radiation hazards .................................................. 20
14 201.11 Protection against excessive temperatures and other hazards ................................................... 20
15 201.12 Accuracy of controls and instruments and protection against hazardous outputs .............. 23
16 201.13 Hazardous situations and fault conditions for ME equipment ...................................................... 30
17 201.14 Programmable electrical medical systems (PEMS) ............................................................................ 31
18 201.15 Construction of ME equipment ................................................................................................................. 31
19 201.16 ME systems ....................................................................................................................................................... 32
20 201.17 Electromagnetic compatibility of ME equipment and ME systems ............................................... 32
21 201.101 Gas connections ..................................................................................................................................... 33
22 201.102 Requirements for the breathing system and accessories ....................................................... 35
23 201.103 * Indication of duration of operation ............................................................................................ 36
24 201.104 Functional connection .......................................................................................................................... 37
25 201.105 Power supply cords ............................................................................................................................... 37
26 201.106 Respiratory high-flow therapy equipment security .................................................................. 37
27 202 Electromagnetic disturbances — Requirements and tests ............................................................ 38
28 206 Usability ........................................................................................................................................................... 38
29 208 General requirements, tests and guidance for alarm systems in medical electrical
30 equipment and medical electrical systems ......................................................................................... 40
31 211 Requirements for medical electrical equipment and medical electrical systems
32 used in the home healthcare environment ......................................................................................... 42
33 Annex C (informative) Guide to marking and labelling requirements for ME equipment and
34 ME systems ....................................................................................................................................................... 43
35 Annex D (informative) Symbols on marking .................................................................................................... 49
36 Annex AA (informative) Particular guidance and rationale ....................................................................... 50
37 Annex BB (informative) Data interface requirements ................................................................................. 63
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oSIST prEN ISO 80601-2-90:2020
ISO 80601-2-90:2020(E)
38 Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances .... 67
39 Annex DD (informative) Reference to the essential principles .................................................................. 70
40 Annex EE (informative) Reference to the general safety and performance requirements............. 73
41 Annex FF (informative) Terminology — Alphabetized index of defined terms .................................. 76
43 Tables44 Table 201.101 — Distributed essential performance requirements ......................................................... 9
45 Table 201.102 — Examples of permissible combinations of temperature and46 relative humidity .......................................................................................................................................... 20
47 Table 201.103 — STPD and BTPS conversion factor for altitude .............................................................. 25
48 Table 201.104 — Test conditions for oxygen concentration tests ............................................................ 27
49 Table 201.C.101 — Marking on the outside of respiratory high-flow therapy equipment,
50 its parts or accessories ............................................................................................................................... 43
51 Table 201.C.102 — Accompanying documents, general ............................................................................... 43
52 Table 201.C.103 — Instructions for use .............................................................................................................. 44
53 Table 201.C.104 — Technical description ......................................................................................................... 48
54 Table 201.D.2.101 — Additional symbols on marking .................................................................................. 49
55 Table BB.101 — Parameters and units of measurement .............................................................................. 64
56 Table BB.102 — Equipment Identification ........................................................................................................ 64
57 Table BB.103 — Usage monitoring ....................................................................................................................... 65
58 Table BB.104 — Equipment settings .................................................................................................................... 65
59 Table BB.105 — Therapy monitoring .................................................................................................................. 65
60 Table BB.106 — Respiratory high-flow therapy equipment alarm limits.............................................. 66
61 Table BB.107 — Event information ...................................................................................................................... 66
62 Table BB.108 — Service monitoring .................................................................................................................... 66
63 Table CC.1 — Correspondence between this document and the essential principles ....................... 67
64 Table CC.2 — Correspondence between this document and the labelling principles ........................ 69
65 Table DD.1 — Correspondence between this document and the essential principles ...................... 70
66 Table EE.1 — Correspondence between this document and the general safety and67 performance requirements ....................................................................................................................... 73
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oSIST prEN ISO 80601-2-90:2020
ISO 80601-2-90:2020(E)
70 Foreword
71 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
72 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
73 technical committees. Each member body interested in a subject for which a technical committee has been
74 established has the right to be represented on that committee. International organizations, governmental and
75 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
76 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
77 The procedures used to develop this document and those intended for its further maintenance are described in
78 the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO
79 documents should be noted. This document was drafted in accordance with the editorial rules of the
80 ISO/IEC Directives, Part 2 (see www.iso.org/directives).81 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
82 rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights
83 identified during the development of the document will be in the Introduction and/or on the ISO list of patent
84 declarations received (see www.iso.org/patents).85 Any trade name used in this document is information given for the convenience of users and does not constitute
86 an endorsement.87 For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions
88 related to conformity assessment, as well as information about ISO's adherence to the World Trade
89 Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
90 www.iso.org/iso/foreword.html.91 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
92 Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical
93 equipment in medical practice, Subcommittee SC D, Electrical equipment. The draft was circulated for voting to
94 the national bodies of both ISO and IEC.95 This is the first edition of ISO 80601-2-90.
© ISO 2020 – All rights reserved v
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oSIST prEN ISO 80601-2-90:2020
ISO 80601-2-90:2020(E)
97 Introduction
98 Respiratory high-flow therapy equipment has been used successfully for years with neonatal patients. In recent
99 years there is more information about treating adults with respiratory high-flow therapy equipment when it is
100 used as an intermediate therapy to improve oxygenation in adult critical care patients, respiratory care units
101 and for palliative care. The use of respiratory high-flow therapy equipment continues to increase as it is easily
102 set up and is well tolerated by patients.103 Since the outbreak of COVID-19 in China in January of 2020, its spread has been rapid and fierce. In hospitals
104 across the world, all kinds of respiratory high-flow therapy equipment have been widely used. More and more
105 new manufacturers of respiratory high-flow therapy equipment have rapidly emerged. Neither international nor
106 national standards are available for respiratory high-flow therapy equipment. With the spread of the epidemic
107 globally, the demand for this document is clear and very urgent.108 The first respiratory high-flow therapy equipment was constructed by the connection of a humidifier, air/oxygen
109 mixer/blender, breathing tube and cannula. Based on the improvement in technical integration in recent years,
110 there are several technical routes for respiratory high-flow therapy equipment on the market. Respiratory high-
111 flow therapy equipment is not fully covered by the existing standards for humidifiers, gas mixers for medical use
112 or ventilators.113 This document addresses the basic safety and essential performance requirements of respiratory high-flow
114 therapy equipment, including risks related to oxygen (e.g., fires, incorrect oxygen concentration, incorrect flow
115 delivery, etc.).116 Specifically, the following risks and related requirements were considered in the development of this document.
117 — The air entering the gas intake port by the respiratory high-flow therapy equipment might be contaminated.
118 What measures are needed to avoid or reduce the contamination of the gas pathways.
119 — The input oxygen source pressure might be unstable.120 — When the pressure of the oxygen source is insufficient, is there an additional gas source, such as adding an
121 additional oxygen input to maintain the delivered oxygen concentration?122 — When the oxygen concentration of the respiratory high-flow therapy equipment does not reach the set value,
123 does the respiratory high-flow therapy equipment need to generate an alarm condition?
124 — Is the respiratory high-flow therapy equipment easy to install and adjust by operators wearing multiple
125 layers of protective clothing and gloves?126 — Are the markings and displays of the respiratory high-flow therapy equipment clear enough for operators
127 whose vision is blurred due to aerosol on their goggles?128 — To reduce unnecessary risk of infection and reduce the burden on the operators, respiratory high-flow
129 therapy equipment needs to remain stable, reducing the need for frequent operator adjustment.
130 — For the respiratory high-flow therapy equipment used in an infected area, after one patient's use, before the
131 next patient's use or before the respiratory high-flow therapy equipment is transferred to a non-infected
132 area, the respiratory high-flow therapy equipment needs cleaning and disinfection, including the surface of
133 the enclosure and the internal gas pathways.134 — The risk of infectious exhaled gas.
135 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
136 In this document, the following print types are used:137 — requirements and definitions: roman type;
138 — test specifications: italic type;
139 — informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
140 text of tables is also in a smaller type.vi © ISO 2020 – All rights reserved
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141 — terms defined in Clause 3 of the general standard , in this document or as noted: small capitals.
142 In referring to the structure of this document, the term143 — “clause” means one of the five numbered divisions within the table of contents, inclusive of all subdivisions
144 (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);145 — “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all subclauses of
146 Clause 201).147 References to clauses within this document are preceded by the term “Clause” followed by the clause number.
148 References to subclauses within this particular document are by number only.149 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
150 the conditions is true.151 The verbal forms used in this document conform to usage described in ISO/IEC Directives, Part 2. For the
152 purposes of this document, the auxiliary verb:153 — “shall” means that conformance with a requirement or a test is mandatory for conformance with this
154 document;155 — “should” means that conformance with a requirement or a test is recommended but is not mandatory for
156 conformance with this document;157 — “may” is used to describe permission (e.g. a permissible way to achieve conformance with a requirement or
158 test);159 — "can" is used to describe a possibility or capability;
160 — "must" is used express an external constraint.
161 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there
162 is guidance or rationale related to that item in Annex AA.163 The ISO and IEC 80601 family of documents are also parts of the IEC 60601 family of documents.
The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance.© ISO 2020 – All rights reserved vii
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oSIST prEN ISO 80601-2-90:2020
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oSIST prEN ISO 80601-2-90:2020
Draft International Standard ISO 80601-2-90:2020(E)
164 Medical electrical equipment
165 Part 2-90:
166 Particular requirements for basic safety and essential
167 performance of respiratory high-flow therapy equipment
168 201.1 Scope, object and related standards
169 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1, applies, except as follows:
170 201.1.1 * Scope
171 Replacement:
172 This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment,
173 as defined in 201.3.219, hereafter also referred to as ME equipment, in combination with its accessories:
174 — intended for use with patients who can breathe spontaneously; and175 — intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from
176 receiving high-flow humidified respiratory gases, including a patient whose upper airway is bypassed.
177 EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation or
178 patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial
179 carbon dioxide is high.180 Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or
181 intended for use in professional healthcare facilities.182 NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
183 Respiratory high-flow therapy equipment can be transit-operable.184 This document is also applicable to those accessories intended by their manufacturer to be connected to the
185 respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety
186 or essential performance of the respiratory high-flow therapy equipment.187 EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external
188 electrical power source, distributed alarm system.189 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only,
190 the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies
191 both to ME equipment and to ME systems, as relevant.192 Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this
193 document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012,
194 7.2.13 and 8.4.1.195 NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
196 This document does not specify the requirements for:197 — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are
[15]198 given in ISO 80601-2-12 ;
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oSIST prEN ISO 80601-2-90:2020
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[16]
199 — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13 ;
200 — ventilators or accessories intended for the emergency medical services environment, which are given in
[21]2201 ISO 80601-2-84 ;
202 — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment,
[18]203 which are given in ISO 80601-2-72 ;
204 — ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are
[19]205 giv
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