EN ISO 80601-2-70:2025
(Main)Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2025)
Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2025)
This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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 7.2.13 and 8.4.1 of the general standard.
NOTE 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
– ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, 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 home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.
Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten (ISO 80601-2-70:2025)
Appareils électromédicaux - Partie 2-70: Exigences particulières pour la sécurité de base et les performances essentielles de l'équipement de thérapie respiratoire pour l'apnée du sommeil (ISO 80601-2-70:2025)
Le présent document s'applique à la sécurité de base et aux performances essentielles des équipements de thérapie respiratoire pour l'apnée du sommeil, désignés ci-après sous le terme d'appareils EM, destinés à soulager les symptômes des patients souffrant d'apnée obstructive du sommeil en délivrant une pression respiratoire à visée thérapeutique dans les voies respiratoires du patient. L'équipement de thérapie respiratoire pour l'apnée du sommeil est destiné à être utilisé dans un environnement de soins à domicile par des opérateurs non spécialistes ainsi que dans des établissements de soins de santé professionnels.
L'équipement de thérapie respiratoire pour l'apnée du sommeil n'est pas censé utiliser de système physiologique de commande en boucle fermée, sauf s'il utilise une variable physiologique du patient pour ajuster les paramètres de traitement.
Le présent document exclut l’équipement de thérapie respiratoire pour l’apnée du sommeil destiné à une utilisation sur des nouveau-nés.
Le présent document s'applique aux appareils EM ou aux systèmes EM destinés à des patients qui ne sont pas dépendants d'une ventilation artificielle. Le présent document ne s'applique pas aux appareils EM ni aux systèmes EM destinés à des patients dépendants d'une ventilation artificielle, tels que des patients souffrant d'une apnée centrale du sommeil.
Le présent document s'applique également aux accessoires destinés par leur fabricant à être raccordés à un équipement de thérapie respiratoire pour l'apnée du sommeil, les caractéristiques de ces accessoires pouvant avoir un impact sur la sécurité de base ou sur les performances essentielles de l'équipement de thérapie respiratoire pour l'apnée du sommeil.
En outre, les masques et les accessoires d'application destinés à être utilisés au cours de la thérapie respiratoire de l'apnée du sommeil sont aussi traités par l'ISO 17510. Pour connaître les éléments couverts par le présent document, se référer à la Figure AA.1.
Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. 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 7.2.13 et 8.4.1 de la norme générale.
NOTE 2 Voir également le paragraphe 4.2 de la norme générale.
Le présent document ne spécifie pas les exigences applicables:
— aux ventilateurs ou aux accessoires destinés aux ventilateurs de soins intensifs pour des patients ventilo-dépendants. Lesdites exigences sont indiquées dans l'ISO 80601‑2‑12;
— aux ventilateurs ou aux accessoires destinés aux applications d'anesthésie. Lesdites exigences sont indiquées dans l'ISO 80601-2-13;
— aux ventilateurs ou aux accessoires destinés à la ventilation à domicile des patients ventilo‑dépendants. Lesdites exigences sont indiquées dans l'ISO 80601-2-72;
— aux ventilateurs ou accessoires de secours et de transport. Lesdites exigences sont indiquées dans l'ISO 80601‑2‑84;
— aux ventilateurs ou aux accessoires destinés aux dispositifs d'assistance respiratoire à domicile. Lesdites exigences sont indiquées dans l'ISO 80601‑2-79 et l
Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO/FDIS 80601-2-70:2025)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-70:2025
01-februar-2025
Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO/DIS
80601-2-70:2024)
Medical electrical equipment - Part 2-70: Particular requirements for basic safety and
essential performance of sleep apnoea breathing therapy equipment (ISO/DIS 80601-2-
70:2024)
Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten
(ISO/DIS 80601-2-70:2024)
Appareils électromédicaux - Partie 2-70: Exigences particulières pour la sécurité de base
et les performances essentielles de l'équipement de thérapie respiratoire pour l'apnée du
sommeil (ISO/DIS 80601-2-70:2024)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-70
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-70:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 80601-2-70:2025
oSIST prEN ISO 80601-2-70:2025
DRAFT
International
Standard
ISO/DIS 80601-2-70
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-70:
Voting begins on:
Particular requirements for basic 2024-12-30
safety and essential performance
Voting terminates on:
2025-03-24
of sleep apnoea breathing therapy
equipment
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
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BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 80601-2-70:2024(en)
oSIST prEN ISO 80601-2-70:2025
DRAFT
ISO/DIS 80601-2-70:2024(en)
International
Standard
ISO/DIS 80601-2-70
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-70:
Voting begins on:
Particular requirements for basic
safety and essential performance
Voting terminates on:
of sleep apnoea breathing therapy
equipment
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
This document is circulated as received from the committee secretariat.
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 80601-2-70:2024(en)
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ISO/DIS 80601-2-70:2024(E)
1 Contents Page
2 Foreword . vi
3 Introduction . vii
4 201.1 Scope, object and related standards . 1
5 1 Scope . 1
6 2 Object . 2
7 3 Collateral standards . 2
8 4 Particular standards . 2
9 201.2 Normative references . 3
10 201.3 Terms and definitions . 4
11 201.4 General requirements . 18
12 201.4.3 Essential performance . 18
13 201.4.3.101 Additional requirements for essential performance . 18
14 201.4.6 ME equipment or ME system parts that contact the patient . 19
15 201.5 General requirements for testing of ME equipment . 19
16 201.5.101 Additional requirements for general requirements for testing of ME equipment. 19
17 201.5.101.1 Gas flowrate and pressure specifications . 19
18 201.5.101.2 Sleep apnoea breathing therapy equipment testing errors . 19
19 201.6 Classification of ME equipment and ME systems . 20
20 201.7 ME equipment identification, marking and documents . 20
21 201.7.1.2 Legibility of markings . 20
22 201.7.2.4.101 Additional requirements for accessories . 20
23 201.7.2.101 Additional requirements for marking on the outside of ME equipment or
24 ME equipment parts . 21
25 201.7.4.3 Units of measurement . 21
26 201.7.9.2 Instructions for use . 21
27 201.7.9.2.1.101 Additional general requirements . 21
28 201.7.9.2.2.101 Additional requirements for warnings and safety notices . 22
29 201.7.9.2.5.101 Additional requirements for ME equipment description . 22
30 201.7.9.2.9.101 Additional requirements for operating instructions . 22
31 201.7.9.2.12 Cleaning, disinfection, and sterilization. 23
32 201.7.9.2.13.101 Additional requirements for maintenance . 23
33 201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment,
34 used material . 23
35 201.7.9.3.1.101 Additional general requirements . 24
36 201.8 Protection against electrical hazards from ME equipment . 25
37 201.9 Protection against mechanical hazards of ME equipment and ME systems . 25
38 201.9.6.2.1.101 Additional requirements for audible acoustic energy . 25
39 201.10 Protection against unwanted and excessive radiation hazards . 27
40 201.11 Protection against excessive temperatures and other hazards . 27
41 201.11.1.2.2 Applied parts not intended to supply heat to a patient . 27
42 201.11.6.6 Cleaning and disinfection of ME equipment or ME system . 27
43 201.11.7 Biocompatibility of ME equipment and ME systems . 28
44 201.11.8 Additional requirements for interruption of the power supply/supply mains to
45 ME equipment . 28
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46 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 29
47 201.12.1 Accuracy of controls and instruments . 29
48 201.12.1.101 Stability of static airway pressure accuracy (long-term accuracy). 29
49 201.12.1.102 Stability of dynamic airway pressure accuracy (short-term accuracy) . 30
50 201.12.1.102.1 CPAP mode . 30
51 201.12.1.102.2 Bi-level positive airway pressure mode, pressure stability . 32
52 201.12.1.103 Maximum flowrate . 35
53 201.12.4 Protection against hazardous output . 38
54 201.12.4.101 Measurement of airway pressure . 38
55 201.12.4.102 Maximum limited pressure protection device . 38
56 201.12.4.103 CO rebreathing . 39
57 201.13 Hazardous situations and fault conditions . 39
58 201.14 Programmable electrical medical systems (PEMS) . 39
59 201.15 Construction of ME equipment . 40
60 201.15.101 Mode of operation . 40
61 201.16 ME systems . 40
62 201.17 Electromagnetic compatibility of ME equipment and ME systems . 40
63 201.101 Breathing gas pathway connectors . 40
64 1 General . 40
65 2 Other named ports . 41
66 2.1 Patient-connection port . 41
67 2.2 Gas output port . 41
68 2.3 Flow-direction-sensitive components . 41
69 2.4 Gas pathway connection port . 41
70 2.5 Monitoring probe port . Error! Bookmark not defined.
71 2.6 Oxygen inlet connector . 42
72 201.101.2.6.1 Low pressure . 42
73 201.101.2.6.2 High pressure . 42
74 201.102 Requirements for the breathing gas pathway and accessories . 43
75 1 General . 43
76 2 Labelling . 43
77 3 Humidification . 43
78 4 Breathing system filter (BSF) . 43
79 201.103 Functional connection . 44
80 1 General . 44
81 2 Functional connection to support remote supervision . 44
82 202 Electromagnetic disturbances — Requirements and tests . 44
83 202.4.3.1 Configurations . 44
84 202.5.2.2.1 Requirements applicable to all ME equipment and ME systems . 44
85 202.8.1.101 Additional general requirements . 44
86 206 Usability . 45
87 211 Requirements for medical electrical equipment and medical electrical systems
88 used in the home healthcare environment . 45
89 211.4.2.3.1 Continuous operating conditions . 46
90 Annex C (informative) Guide to marking and labelling requirements for ME equipment
91 and ME systems . 47
92 201.C.1 Marking on the outside of ME equipment, ME systems or their parts . 47
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93 201.C.2 Accompanying documents, general . 47
94 201.C.3 Accompanying documents, instructions for use . 48
95 201.C.4 Accompanying documents, technical description . 50
96 Annex AA (informative) Particular guidance and rationale . 51
97 AA.1 General guidance . 51
98 AA.2 Rationale for particular clauses and subclauses . 52
99 Annex BB (informative) Data interface requirements . 60
100 BB.1 Background and purpose . 60
101 BB.2 Data definition . 61
102 Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 64
103 Annex DD (informative) Terminology — alphabetized index of defined terms . 67
104 Bibliography . 71
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106 Foreword
107 ISO (the International Organization for Standardization) is a worldwide federation of national standards
108 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
109 through ISO technical committees. Each member body interested in a subject for which a technical
110 committee has been established has the right to be represented on that committee. International
111 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
112 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
113 electrotechnical standardization.
114 The procedures used to develop this document and those intended for its further maintenance are
115 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
116 different types of ISO documents should be noted. This document was drafted in accordance with the
117 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
118 Attention is drawn to the possibility that some of the elements of this document may be the subject of
119 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
120 patent rights identified during the development of the document will be in the Introduction and/or on
121 the ISO list of patent declarations received (see www.iso.org/patents).
122 Any trade name used in this document is information given for the convenience of users and does not
123 constitute an endorsement.
124 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
125 expressions related to conformity assessment, as well as information about ISO's adherence to the World
126 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
127 www.iso.org/iso/foreword.html.
128 This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
129 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
130 Technical Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC D, Particular
131 medical equipment, software, and systems, in collaboration with the European Committee for
132 Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
133 accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
134 This third edition cancels and replaces the second edition (ISO 80601-2-70:2020), which has been
135 technically revised.
136 The main changes compared to the previous edition are as follows:
137 — updated references;
138 — updated the audible acoustic energy requirements; and
139 — updated the maximum flowrate test method.
140 A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
141 Any feedback or questions on this document should be directed to the user’s national standards body. A
142 complete listing of these bodies can be found at www.iso.org/members.html.
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143 Introduction
144 Sleep apnoea is a chronic medical condition where the patient repeatedly stops breathing during sleep.
145 These episodes typically last 10 s or more and cause the oxygen levels in the blood to drop. It can be
146 caused by obstruction of the upper airway (obstructive sleep apnoea or OSA) or by a failure of the brain
147 to initiate a breath (central sleep apnoea).
148 NOTE Sleep apnoea breathing therapy equipment is intended for the treatment of obstructive sleep apnoea and
149 not central sleep apnoea.
150 Sleep apnoea, if untreated, can cause and worsen other medical conditions, including hypertension, heart
[22]
151 failure and diabetes .
152 Hypopnoea refers to a transient reduction of airflow, often while the patient is asleep, that lasts for at
153 least 10 s, shallow breathing. It also results in arousal or can cause oxygen saturation to drop. Hypopnoea
[20]
154 is less severe than apnoea. It is commonly due to partial obstruction of the upper airway .
155 Awareness of the risks associated with obstructive sleep apnoea has grown significantly. As a result, the
156 use of sleep apnoea breathing therapy equipment to treat obstructive sleep apnoea has become common.
157 This document covers basic safety and essential performance requirements needed to protect patients in
158 the use of this ME equipment.
159 This document covers sleep apnoea breathing therapy equipment for patient use. ISO 17510 applies to
160 masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient.
161 Figure AA.1 shows this diagrammatically.
162 In this document, the following print types are used:
163 — Requirements and definitions: roman type
164 — Terms defined in clause 3 of the general standard, in this document or as noted: italic type;
165 — Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
166 Normative text of tables is also in a smaller type;
167 In referring to the structure of this document, the term.
168 — “clause” means one of the four numbered divisions within the table of contents, inclusive of all
169 subdivisions (e.g. Clause 201 includes subclauses 201.1, 201.2, etc.);
170 — “subclause” means a numbered subdivision of a clause (e.g. 201.101, 201.102 and 201.102.1 are all
171 subclauses of Clause 201).
172 References to clauses within this document are preceded by the term “Clause” followed by the clause
173 number. References to subclauses within this document are by number only.
174 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
175 of the conditions is true.
176 For the purposes of this document, the auxiliary verb:
177 – “shall” indicates a requirement;
178 – “should” indicates a recommendation;
179 – “may” indicates a permission;
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180 – "can" is used to describe a possibility or capability; and
181 – "must" is used to express an external constraint.
182 Annex C contains a guide to the marking and labelling requirements in this document.
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184 Medical electrical equipment —
185 Part 2-70:
186 Particular requirements for the basic safety and essential
187 performance of sleep apnoea breathing therapy equipment
188 201.1 Scope, object and related standards
189 NOTE There is guidance or rationale for this subclause contained in Clause AA.2
190 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
191 NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
192 1 Scope
193 NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2
194 IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.1 is replaced by:
195 This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy
196 equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer
197 from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the
198 patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by
199 lay operators as well as in professional healthcare institutions.
200 Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system
201 unless it uses a physiological patient variable to adjust the therapy settings.
202 This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
203 This document is applicable to ME equipment or an ME system intended for those patients who are not
204 dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended
205 for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
206 This document is also applicable to those accessories intended by their manufacturer to be connected to sleep
207 apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety
208 or essential performance of the sleep apnoea breathing therapy equipment.
209 Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally
210 addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
211 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only,
212 the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies
213 both to ME equipment and to ME systems, as relevant.
214 Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this
215 document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general
216 standard.
217 NOTE 2 See also 4.2 of the general standard.
oSIST prEN ISO 80601-2-70:2025
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218 This document does not specify the requirements for:
219 – ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are
220 given in ISO 80601-2-12.
221 – ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
222 – ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are
223 given in ISO 80601-2-72.
224 – ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
225 – ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79
226 and ISO 80601-2-80.
227 – high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given
228 in ISO 80601-2-87.
[23]
229 – high-frequency oscillatory ventilators (HFOVs) ;
230 – respiratory high flow equipment, which are given in ISO 80601-2-90;
231 NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but
232 such a mode is only for spontaneously breathing patients.
233 – user-powered resuscitators, which are given in ISO 10651-4;
234 – gas-powered emergency resuscitators, which are given in ISO 10651-5;
235 – oxygen therapy constant flow ME equipment; and
236 – cuirass or “iron-lung” ventilation equipment.
237 2 Object
238 IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.2 is replaced by:
239 The object of this document is to establish particular basic safety and essential performance requirements for
240 sleep apnoea breathing therapy equipment (as defined in 201.3.259).
[17] [18]
241 NOTE 1 This document has been prepared to address the relevant essential principles and labelling principles guidances of the
242 International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.
243 NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of European
[16]
244 regulation (EU) 2017/745 .
245 3 Collateral standards
246 IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:
247 IEC 60601-1-2:2014+AMD1:2020 and IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 apply as modified in
248 Clauses 202, 206 and 211 respectively. IEC 60601-1-3 and IEC 60601-1-9 do not apply. All other published
249 collateral standards in the IEC 60601-1 series apply as published.
250 4 Particular standards
251 Replacement:
252 In the IEC 60601 series, particular standards define basic safety and essential performance requirements, and
253 may modify, replace or delete requirements contained in the general standard and collateral standards as
254 appropriate for the particular ME equipment under consideration.
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ISO/DIS 80601-2-70:2024(E)
255 A requirement of a particular standard takes priority over the general standard.
256 For brevity, IEC 60601-1+AMD1:2012+AMD2:2020 is referred to in this document as the general standard.
257 Collateral standards are referred to by their document number.
258 The numbering of clauses and subclauses of this document corresponds to that of the general standard with
259 the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or
260 applicable collateral standard with the prefix “20x”, where x is the final digit(s) of the collateral standard
261 document number (e.g. 202.4 in this document addresses the content of Clause 4 of the IEC 60601-1-2 collateral
262 standard, 203.4 in this document addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard,
263 etc.). The changes to the text of the general standard are specified by the use of the following words:
264 "Replacement" means that the clause or subclause of the general standard or applicable collateral standard is
265 replaced completely by the text of this document.
266 "Addition" means that the text of this document is additional to the requirements of the general standard or
267 applicable collateral standard.
268 "Amendment" means that the clause or subclause of the general standard or applicable collateral standard is
269 amended as indicated by the text of this document.
270 Subclauses, figures or tables which are additional to those of the general standard are numbered starting from
271 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.139,
272 additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are
273 lettered AA, BB, etc., and additional items aa), bb), etc.
274 Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from
275 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 211 for IEC 60601-1-11, etc.
276 The term "this document" is used to make reference to the general standard, any applicable collateral standards
277 and this document taken together.
278 Where there is no corresponding clause or subclause in this document, the clause or subclause of the general
279 standard or applicable collateral standard, although possibly not relevant, applies without modification; where
280 it is intended that any part of the general standard or applicable collateral standard, although possibly relevant,
281 is not to be applied, a statement to that effect is given in this document.
282 201.2 Normative references
283 The following documents are referred to in the text in such a way that some or all of their content constitutes
284 requirements of this document. For dated references, only the edition cited applies. For undated references, the
285 latest edition of the referenced document (including any amendments) applies.
286 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
287 Addition:
288 ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
289 sound pressure — Engineering methods for an essentially free field over a reflecting plane
290 ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and equipment
291 ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Cones and sockets
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ISO/DIS 80601-2-70:2024(E)
292 ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
293 sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
294 ISO 17510:— , Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
295 ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
296 manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
297 ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
298 manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
299 ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
300 Evaluation and testing within a risk management process
301 ISO 20417:— , Medical devices — Information to be supplied by the manufacturer
302 ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to
303 assess filtration performance
304 ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
305 ISO 80369-1:— , Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
306 requirements
307 ISO 80601-2-74:— , Medical electrical equipment — Part 2-74: Particular requirements for basic safety and
308 essential performance of respiratory humidifying equipment
309 IEC 81001-5-1:2021, Health software and health IT systems safety, effectiveness and security — Part 5-1:
310 Security — Activities in the product life cycle
311 IEC Guide 115:2023, Application of uncertainty of measurement to conformity assessment activities in the
312 electrotechnical sector
313 201.3 Terms and definitions
314 For the purposes of this document, the terms and definitions given in
315 IEC 60601-1:2005+AMD1:2012+AMD2:2020, and the following apply.
316 ISO and IEC maintain terminology databases for use in standardization at the following addresses:
317 — ISO Online browsing platform: available at https://www.iso.org/obp
318 — IEC Electropedia: available at http://www.electropedia.org/
319 Addition:
Under preparation. Stage at the time of publication: ISO/DIS 17510:2024.
Under preparation. Stage at the time of publication: ISO/DIS 20417:2024.
Under preparation. Stage at the time of publication: ISO/FDIS 80369-1:2024.
Under preparation. Stage at the time of publication: ISO/DIS 80601-2-74:2024.
oSIST prEN ISO 80601-2-70:2025
ISO/DIS 80601-2-70:2024(E)
320 201.3.201
321 accompanying information
322 information accompanying or marked on a medical device or accessory for the user or those accountable for the
323 installation, use, processing, maintenance, decommissioning and disposal of the medical device or accessory,
324 particularly regarding safe use
325 Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
326 Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical description,
327 installation manual, quick reference guide, etc.
328 Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory,
329 visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).
330 [SOURCE: ISO 20417:—, 3.2, modified — deleted note 4.]
331 201.3.202
332 airway
333 connected, gas-containing cavities and passages within the respiratory system, that conduct gas between the
334 alveoli and the oral and nasal orifices on the surface of the face, or the patient-connection port if an airway
335 device is used
336 Note 1 to entry: This is a well-established term that is commonly used in isolation in references to the airway of a patient.
337 Depending on the context, it is sometimes more helpful to use the qualified term, patient's airway.
338 [SOURCE: ISO 19223:2019, 3.1.2, modified — deleted note 2.]
339 201.3.203
340 airway pressure
341 P
aw
342 pressure at the patient-connection port or at the distal outlet of the equipment where there is no patient-
343 connection port
344 Note 1 to entry: The airway pressure can be derived from pressure measurements made anywhere within the equipment.
345 [SOURCE: ISO 4135:2022, 3.1.4.41.1]
346 201.3.204
347 airway pressure accuracy
348 degree of correspondence between the pressure set on the sleep apnoea breathing therapy equipment and the
349 actual (true) airway pressure
350 201.3.205
351 artificial ventilation
352 intermittent elevation of the pressure in the patient's airway relative to that in the lungs by external means with
353 the intention of augmenting, or totally controlling, the ventilation of a patient
354 EXAMPLE Means used to provide artificial ventilation are manual resuscitation; mouth-to-mouth resuscitation; automatic
355 ventilation; mechanical ventilation.
356 Note 1 to entry: Common classifications of areas of application of artificial ventilation are: emergency; transport; home-
357 care; anaesthesia; critical care; rehabilitation.
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ISO/DIS 80601-2-70:2024(E)
358 Note 2 to entry: Classifications used to denote means used for artificial ventilation include: positive-pressure; negative-
359 pressure; gas-powered; operator-powered; electrically-powered.
360 Note 3 to entry: Negative-pressure ventilation elevates the relative pressure in the airway by intermittently lowering the
361 pressure in the lungs.
362 [SOURCE: ISO 19223:2019, 3.1.10]
363 201.3.206
364 attack
365 attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized use of an
366 asset
367 [SOURCE: IEC 81001-5-1:2021, 3.5]
368 201.3.207
369 auto CPAP
370 operating mode in which the sleep apnoea breathing therapy equipment automatically adjusts the applied gas
371 pressure level within a clinically predetermined range to prevent disturbances of the patient’s breathing at the
372 lowest necessary pressure
373 Note 1 to entry: These disturbances are typically obstructive apnoea (cessation of air flow) or hypopnoea (shallow
374 breathing) events.
375 Note 2 to entry: An auto CPAP mode may be bi-level.
376 Note 3 to entry: There is guidance or rationale for this definition contained in Clause AA.2.
377 201.3.208
378 automatic start/stop function
379 feature by which the sleep apnoea breathing therapy equipment automatically starts or stops the therapy based
380 on whether the patient is connected or disconnected from the equipment
381 Note 1 to entry: Sleep apnoea breathing therapy equipment may provide an automatic start function, an automatic stop
382 function, or both.
383 Note 2 to entry: There is guidance or rationale for this definition contained in Clause AA.2.
384 201.3.209
385 bi-level PAP
386 bi-level positive airway pressure
387 sleep-apnoea breathing-therapy mode in which there are two therapeutic positive pressure levels at the
388 patient-connection port during the respiratory cycle
389 Note 1 to entry: The two levels of positive airway pressure (PAP) invoked by the various names that have been given to
390 this breathing-therapy mode are typically identified by the terms IPAP (inspiratory positive airway pressure) and EPAP
391 (expiratory positive airway pressure), with IPAP representing the set inspiratory pressure level during the patient's
392 inspiratory phase and EPAP the set baseline airway
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