SIST EN ISO 80601-2-70:2021

SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-70:2019
01-december-2019
Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO/DIS
80601-2-70:2019)
Medical electrical equipment - Part 2-70: Particular requirements for basic safety and
essential performance of sleep apnoea breathing therapy equipment (ISO/DIS 80601-2-
70:2019)
Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten
(ISO/DIS 80601-2-70:2019)
Appareils électromédicaux - Partie 2-70: Exigences particulières pour la sécurité de base
et les performances essentielles du matériel de traitement respiratoire de l'apnée du
sommeil (ISO/DIS 80601-2-70:2019)
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 80601-2-70:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80601-2-70:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-70
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-09-27 2019-12-20
Medical electrical equipment —
Part 2-70:
Particular requirements for basic safety and essential
performance of sleep apnoea breathing therapy equipment
Appareils électromédicaux —
Partie 2-70: Exigences particulières pour la sécurité de base et les performances essentielles du matériel de
traitement respiratoire de l'apnée du sommeil
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
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 80601-2-70:2019(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 2019

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COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2019 – All rights reserved

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1 CONTENTS
2 CONTENTS . 3
3 FOREWORD . 5
4 INTRODUCTION . 7
5 201.1 Scope, object and related standards . 9
6 201.2 Normative references . 11
7 201.3 Terms and definitions . 14
8 201.4 General requirements . 16
9 201.5 General requirements for testing of ME equipment . 17
10 201.6 Classification of ME equipment and ME systems . 17
11 201.7 ME equipment identification, marking and documents . 17
12 201.8 Protection against electrical hazards from ME equipment . 22
13 201.9 Protection against mechanical hazards of ME equipment and ME systems . 23
14 201.10 Protection against unwanted and excessive radiation hazards . 24
15 201.11 Protection against excessive temperatures and other hazards . 25
16 201.12 Accuracy of controls and instruments and protection against hazardous
17 outputs . 27
18 201.13 Hazardous situations and fault conditions . 34
19 201.14 Programmable electrical medical systems (pems) . 34
20 201.15 Construction of ME equipment . 34
21 201.16 ME systems. 34
22 201.17 Electromagnetic compatibility of ME equipment and ME systems . 34
23 201.101 Breathing gas pathway connectors . 35
24 201.102 Requirements for the breathing gas pathway and accessories . 36
25 201.103 Functional connection . 37
26 201.104 Training . 37
27 202 Electromagnetic disturbances – Requirements and tests . 37
28 206 Usability . 38
29 211 Requirements for medical electrical equipment and medical electrical systems
30 used in the home healthcare environment . 39
31 Annex C (informative) Guide to marking and labelling requirements for ME equipment
32 and ME systems . 40
33 Annex D (informative) Symbols on marking . 44
34 Annex AA (informative) Particular guidance and rationale . 45
35 Annex BB (informative) Data interface requirements . 51
36 Annex CC (informative) Reference to the essential principles . 55

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37 Annex DD (informative) Reference to the general safety and performance requirements . 58
38 Annex EE (informative) Terminology — alphabetized index of defined terms . 62
39
40 Figure 201.101 – Standard resistance . 24
41 Figure 201.102 – Test set-up for static airway pressure accuracy in normal use . 28
42 Figure 201.103 – Test set-up for dynamic airway pressure accuracy in normal use . 30
43 Figure AA.1 – Relationship of the components of sleep apnoea breathing therapy
44 equipment and masks and application accessories and the related standards . 45
45
46 Table 201.101 — Examples of permissible combinations of temperature and
47 relative humidity . 25
48 Table BB.101 – Parameters and units of measurement . 52
49 Table BB.102 – Equipment identification . 52
50 Table BB.103 – Session compliance monitoring . 53
51 Table BB.104 – Session efficacy monitoring . 53
52 Table BB.105 – Equipment therapy settings . 54
53 Table BB.106 – Service monitoring . 54
54 Table CC.1 — Correspondence between this document and the essential principles . 55
55 Table DD.1 — Correspondence between this document and the general safety and
56 performance requirements . 58
57
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58 INTERNATIONAL ORGANIZATION for STANDARDISATION
59 ____________
60
61 MEDICAL ELECTRICAL EQUIPMENT –
62
63 Part 2-70: Particular requirements for the basic safety and
64 essential performance of sleep apnoea breathing therapy equipment
65
66
67 FOREWORD
68 ISO (the International Organization for Standardization) is a worldwide federation of national
69 standards bodies (ISO member bodies). The work of preparing International Standards is
70 normally carried out through ISO technical committees. Each member body interested in a subject
71 for which a technical committee has been established has the right to be represented on that
72 committee. International organizations, governmental and non-governmental, in liaison with ISO,
73 also take part in the work. ISO collaborates closely with the International Electrotechnical
74 Commission (IEC) on all matters of electrotechnical standardization.
75 The procedures used to develop this document and those intended for its further maintenance are
76 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for
77 the different types of ISO documents should be noted. This document was drafted in accordance
78 with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
79 Attention is drawn to the possibility that some of the elements of this document may be the subject
80 of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
81 Details of any patent rights identified during the development of the document will be in the
82 Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents
An
83 y trade name used in this document is information given for the convenience of users and does
84 not constitute an endorsement.
85 ISO 80601-2-70 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
86 equipment, Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee
87 IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment. The
88 of both ISO and IEC.
draft was circulated for voting to the national bodies
89 This second edition of ISO 80601-2-70 cancels and replaces the first edition of
90 ISO 80601-2-70:2015. This edition of ISO 80601-2-70 constitutes a technical revision of
91 ISO 80601-2-70:2015 and includes an alignment with the third edition of IEC 60601-1-6,
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92 including its Amendment 2, the second edition of IEC 60601-1-8, including its Amendment 2, and
93 the second edition of IEC 60601-1-11.
94 The most significant changes are the following modifications:
95 – modified the bi-level positive airway pressure mode stability test method;
96 – modified the biocompatibility requirements
97 – added additional defined terms.
98
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99 INTRODUCTION
100 Sleep apnoea is a chronic medical condition where the patient repeatedly stops breathing during
101 sleep. These episodes typically last 10 s or more and cause the oxygen levels in the blood to drop.
102 It can be caused by obstruction of the upper airway (obstructive sleep apnoea or OSA) or by a
103 failure of the brain to initiate a breath (central sleep apnoea).
104 NOTE Sleep apnoea breathing therapy equipment is intended for the treatment of obstructive sleep
105 apnoea and not central sleep apnoea.
106 Sleep apnoea, if untreated, can cause and worsen other medical conditions, including
[1]
107 hypertension, heart failure and diabetes .
108 Hypopnoea refers to a transient reduction of airflow, often while the patient is asleep, that lasts
109 for at least 10 s, shallow breathing, or an abnormally low respiratory rate. Hypopnoea is less
110 severe than apnoea. It also results in decreased air movement into the lungs and can cause oxygen
[2]
111 levels in the blood to drop. It is commonly due to partial obstruction of the upper airway .
112 Awareness of the risks associated with sleep apnoea has grown significantly. As a result, the use
113 of sleep apnoea breathing therapy equipment to treat both sleep apnoea and hypopnoea has
114 become common.
115 This document covers basic safety and essential performance requirements needed to protect
116 patients in the use of this ME equipment.
117 ISO 80601-2-70 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510
118 applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the
119 patient. Figure AA.1 shows this diagrammatically.
120 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
121 In this document, the following print types are used:
122 – Requirements and definitions: roman type
123 – Test specifications and terms defined in clause 3 of the general standard, in this document or as
124 noted: italic type
125 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
126 Normative text of tables is also in a smaller type
127 In referring to the structure of this document, the term
128 – “clause” means one of the four numbered divisions within the table of contents, inclusive of all
129 subdivisions (e.g. Clause 201 includes subclauses 201.1, 201.2, etc.);
130 – “subclause” means a numbered subdivision of a clause (e.g. 201.101, 201.102 and 201.102.1
131 are all subclauses of Clause 201).
132 References to clauses within this document are preceded by the term “Clause” followed by the
133 clause number. References to subclauses within this document are by number only.
134 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
135 combination of the conditions is true.
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136 The verbal forms used in this document conform to usage described in ISO/IEC Directives, Part 2.
137 For the purposes of this document, the auxiliary verb:
138 – “shall” means that conformance with a requirement or a test is mandatory for conformance
139 with this document;
140 – “should” means that conformance with a requirement or a test is recommended but is not
141 mandatory for conformance with this document;
142 – “may” is used to describe a permission (e.g. a permissible way to achieve conformance with a
143 requirement or test);
144 – "can" is used to describe a possibility or capability; and
145 – "must" is used express an external constraint.
146 Annex C contains a guide to the marking and labelling requirements in this document.
147 Annex D contains a summary of the symbols referenced in this document.
148 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
149 indicates that there is guidance or rationale related to that item in Annex AA.
150 The ISO and IEC 80601 family of standards are also parts of the IEC 60601 family of standards.
151
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152 MEDICAL ELECTRICAL EQUIPMENT –
153
154 Part 2-70: Particular requirements for the basic safety and
155 essential performance of sleep apnoea breathing therapy equipment
156 201.1 * Scope, object and related standards
1
157 IEC 60601-1:2005+A1:2012 , Clause 1 applies, except as follows:
158 1 Scope
159 IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by:
160 This document is applicable to the basic safety and essential performance of sleep apnoea breathing
161 therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of
162 patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure
163 to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for
164 use in the home healthcare environment by lay operators as well as in professional healthcare
165 institutions.
166 * Sleep apnoea breathing therapy equipment is not considered to utilize physiologic closed-loop-
167 control system unless it uses a physiological patient variable to adjust the therapy settings.
168 This document excludes sleep apnoea breathing therapy equipment intended for use with
169 neonates.
170 This document is applicable to ME equipment or an ME system intended for those patients who are
171 not dependent on mechanical ventilation.
172 This document is not applicable to ME equipment or an ME system intended for those patients who
173 are dependent on mechanical ventilation such as patients with central sleep apnoea.
174 This document is also applicable to those accessories intended by their manufacturer to be
175 connected to sleep apnoea breathing therapy equipment, where the characteristics of those
176 accessories can affect the basic safety or essential performance of the sleep apnoea breathing
177 therapy equipment.
178 Masks and application accessories intended for use during sleep apnoea breathing therapy are
179 additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this
180 document.
181 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to
182 ME systems only, the title and content of that clause or subclause will say so. If that is not the case,
183 the clause or subclause applies both to ME equipment and to ME systems, as relevant.

1
 The general standard is IEC 60601-1:2005 +AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
1
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184 Hazards inherent in the intended physiological function of ME equipment or ME systems within the
185 scope of this document are not covered by specific requirements in this document except in 7.2.13
186 and 8.4.1 of the general standard.
187 NOTE See also 4.2 of the General Standard.
188 This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency
189 oscillatory ventilators (HFOVs) [1], which are given in ISO 80601-2-87 [3].
190 This document does not specify the requirements for ventilators or accessories intended for
191 critical care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-12. [4]
192 This document does not specify the requirements for ventilators or accessories intended for
193 anaesthetic applications, which are given in ISO 80601-2-13. [5]
194 This document does not specify the requirements for ventilators or accessories intended for home
195 care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. [6]
196 This document does not specify the requirements for ventilators or accessories intended for
2)
197 emergency and transport, which are given in ISO 10651-3 . [7]
198 This document does not specify the requirements for ventilators or accessories intended for home-
199 care ventilatory support, which are given in ISO 80601-2-79 [8] and ISO 80601-2-80.
200 This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.
201 2 Object
202 IEC 60601-1:2005, 1.2 is replaced by:
203 The object of this document is to establish particular basic safety and essential performance
204 requirements for sleep apnoea breathing therapy equipment [as defined in 201.3.222].
205 NOTE 1 This document has been prepared to address the relevant essential principles of safety and performance
206 of ISO 16142-1:2016 as indicated in Annex CC.
207 NOTE 2 This document has been prepared to address the relevant general safety and performance
[19]
208 requirements of European regulation (EU) 2017/745 as indicated in Annex DD.
209 3 Collateral standards
210 IEC 60601-1:2005+AMD 1:2012, 1.3 applies with the following addition:
211 IEC 60601-1-2:2014 and IEC 60601-1-6:2010+AMD1:2013+AMD2:— apply as modified in
212 Clauses 202 and 206 respectively. IEC 60601-1-3:2008+AMD 1:2013 does not apply. All other
213 published collateral standards in the IEC 60601-1 series apply as published.
214 4 Particular standards
215 Replacement:
216 In the IEC 60601 series, particular standards may modify, replace or delete requirements
217 contained in the general standard and collateral standards as appropriate for the particular

2)
In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 at which time it will be replaced by ISO 80601-

2-xx.
2
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218 ME equipment under consideration, and may add other basic safety and essential performance
219 requirements.
220 A requirement of a particular standard takes priority over the general standard.
221 For brevity, IEC 60601-1 is referred to in this document as the general standard. Collateral
222 standards are referred to by their document number.
223 The numbering of clauses and subclauses of this document corresponds to that of the general
224 standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of
225 the general standard) or applicable collateral standard with the prefix “20x”, where x is the final
226 digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses the
227 content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the
228 content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the
229 general standard are specified by the use of the following words:
230 "Replacement" means that the clause or subclause of the general standard or applicable collateral
231 standard is replaced completely by the text of this document.
232 "Addition" means that the text of this document is additional to the requirements of the general
233 standard or applicable collateral standard.
234 "Amendment" means that the clause or subclause of the general standard or applicable collateral
235 standard is amended as indicated by the text of this document.
236 Subclauses, figures or tables which are additional to those of the general standard are numbered
237 starting from 201.101. However, due to the fact that definitions in the general standard are
238 numbered 3.1 through 3.139, additional definitions in this document are numbered beginning
239 from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
240 Subclauses, figures or tables which are additional to those of a collateral standard are numbered
241 starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2,
242 203 for IEC 6060-1-3, etc.
243 The term "this document" is used to make reference to the general standard, any applicable
244 collateral standards and this document taken together.
245 Where there is no corresponding clause or subclause in this document, the clause or subclause of
246 the general standard or applicable collateral standard, although possibly not relevant, applies
247 without modification; where it is intended that any part of the general standard or applicable
248 collateral standard, although possibly relevant, is not to be applied, a statement to that effect is
249 given in this document.
250 201.2 Normative references
251 The following referenced documents, in whole or in part, are normatively referenced in this
252 document and are indispensable for the application of this document. For dated references, only
253 the edition cited applies. For undated references, the latest edition of the referenced document
254 (including any amendments) applies.
3
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255 NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent
256 (in whole or in part) to which they apply.
257 NOTE 2 Informative references are listed in the Bibliography.
258 IEC 60601-1:2005+AMD 1:2012, Clause 2 applies, except as follows:
259 Replacement:
260 IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic
261 safety and essential performance — Collateral standard: Electromagnetic disturbances —
262 Requirements and tests
263 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
264 safety and essential performance – Collateral standard: Usability
3)
265 +Amendment 1:2013
4)
266 +Amendment 2:—
267 IEC 60601-1-8:2006, Medical electrical equipment - Part 1-8: General requirements for basic
268 safety and essential performance - Collateral Standard: General requirements, tests and guidance
269 for alarm systems in medical electrical equipment and medical electrical systems
5)
270 +Amendment 1:2012
6)
271 +Amendment 2:—
272 IEC 60601-1-10:2007, Medical electrical equipment -- Part 1-10: General requirements for basic
273 safety and essential performance -- Collateral standard: Requirements for the development of
274 physiologic closed-loop controllers
275 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic
276 safety and essential performance – Collateral Standard: Requirements for medical electrical
277 equipment and medical electrical systems used in the home healthcare environment
278 IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
279 ISO 7010:2011, Graphical symbols -- Safety colours and safety signs -- Registered safety signs
280 +Amendment 1:2012
281 +Amendment 2:2012
282 +Amendment 3:2012
283 +Amendment 4:2013
284 +Amendment 5:2013
285 +Amendment 6:2014
286 ISO 15223-1:2016, Medical devices — Symbols to be used wi
...