SIST EN ISO 18778:2023

SLOVENSKI STANDARD
oSIST prEN ISO 18778:2021
01-september-2021
Respiratorna oprema - Posebne zahteve za osnovno varnost in bistveno
učinkovitost opreme za srčnospiratorne monitorje za otroke (ISO/DIS 18778:2021)
Respiratory equipment - Particular requirements for basic safety and essential
performance of equipment for infant cardiorespiratory monitors (ISO/DIS 18778:2021)
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von kardiorespiratorischen
Überwachungsgeräten für Kleinkinder (ISO/DIS 18778:2021)
Appareils électromédicaux - Exigences particulières relatives à la sécurité de base et
aux performances essentielles des appareils de surveillance cardiorespiratoire des
nourrissons (ISO/DIS 18778:2021)
Ta slovenski standard je istoveten z: prEN ISO 18778
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 18778:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 18778:2021

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oSIST prEN ISO 18778:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18778
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-04-26 2021-07-19
Respiratory equipment — Particular requirements for 6
basic safety and essential performance of equipment for 7
infant cardiorespiratory monitors —
Part :
Particular requirements for basic safety and essential
performance of equipment for infant cardiorespiratory
monitors
ICS: 11.040.55; 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 18778:2021(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 2021

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oSIST prEN ISO 18778:2021
ISO DIS 80601-2-88  ISO 2021 – 3 –
ISO/DIS 18778:2021(E)

33 CONTENTS
34 CONTENTS . 3
35 FOREWORD . 5
36 INTRODUCTION . 7
37 201.1 Scope, object and related standards . 9
38 201.2 Normative references . 11
39 201.3 Terms and definitions. 12
40 201.4 General requirements . 17
41 201.5 General requirements for testing of ME equipment . 18
42 201.6 Classification of ME equipment and ME systems . 18
43 201.7 ME equipment identification, marking and documents . 19
44 201.8 Protection against electrical hazards from ME equipment . 22
45 201.9 Protection against mechanical hazards of ME equipment and ME systems . 22
46 201.10 Protection against unwanted and excessive radiation hazards . 23
47 201.11 Protection against excessive temperatures and other hazards . 23
48 201.12 Accuracy of controls and instruments and protection against hazardous
49 outputs . 26
50 201.13 Hazardous situations and fault conditions for ME equipment . 30
51 201.14 Programmable electrical medical systems (PEMS) . 30
52 201.15 Construction of ME equipment . 30
53 201.16 ME systems . 31
54 201.17 Electromagnetic compatibility of ME equipment and ME systems . 31
55 201.101 Requirements for the accessories . 31
56 201.102 * Training . 31
57 201.103 Functional connection . 31
58 202 Electromagnetic disturbances – Requirements and tests . 32
59 206 Usability . 32
60 208 General requirements, tests and guidance for alarm systems in medical
61 electrical equipment and medical electrical systems . 33
62 211 Requirements for medical electrical equipment and medical electrical
63 systems used in the home healthcare environment . 34
COPYRIGHT PROTECTED DOCUMENT
64 Annex C (informative) Guide to marking and labelling requirements for
65 ME equipment and ME systems . 36
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
66 Annex D (informative) Symbols on marking . 39
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
67 Annex AA (informative) Particular guidance and rationale. 40
below or ISO’s member body in the country of the requester.
68 Annex BB (informative) Data interface requirements . 46
ISO copyright office
CP 401 • Ch. de Blandonnet 8
69 Annex CC (informative) Considerations for a clinical performance study . 49
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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oSIST prEN ISO 18778:2021
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33 CONTENTS
34 CONTENTS . 3
35 FOREWORD . 5
36 INTRODUCTION . 7
37 201.1 Scope, object and related standards . 9
38 201.2 Normative references . 11
39 201.3 Terms and definitions. 12
40 201.4 General requirements . 17
41 201.5 General requirements for testing of ME equipment . 18
42 201.6 Classification of ME equipment and ME systems . 18
43 201.7 ME equipment identification, marking and documents . 19
44 201.8 Protection against electrical hazards from ME equipment . 22
45 201.9 Protection against mechanical hazards of ME equipment and ME systems . 22
46 201.10 Protection against unwanted and excessive radiation hazards . 23
47 201.11 Protection against excessive temperatures and other hazards . 23
48 201.12 Accuracy of controls and instruments and protection against hazardous
49 outputs . 26
50 201.13 Hazardous situations and fault conditions for ME equipment . 30
51 201.14 Programmable electrical medical systems (PEMS) . 30
52 201.15 Construction of ME equipment . 30
53 201.16 ME systems . 31
54 201.17 Electromagnetic compatibility of ME equipment and ME systems . 31
55 201.101 Requirements for the accessories . 31
56 201.102 * Training . 31
57 201.103 Functional connection . 31
58 202 Electromagnetic disturbances – Requirements and tests . 32
59 206 Usability . 32
60 208 General requirements, tests and guidance for alarm systems in medical
61 electrical equipment and medical electrical systems . 33
62 211 Requirements for medical electrical equipment and medical electrical
63 systems used in the home healthcare environment . 34
64 Annex C (informative) Guide to marking and labelling requirements for
65 ME equipment and ME systems . 36
66 Annex D (informative) Symbols on marking . 39
67 Annex AA (informative) Particular guidance and rationale. 40
68 Annex BB (informative) Data interface requirements . 46
69 Annex CC (informative) Considerations for a clinical performance study . 49

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70 Annex DD (informative) Reference to the IMDRF essential principles and labelling
71 guidances . 51
72 Annex EE (informative) Reference to the essential principles . 53
73 Annex FF (informative) Reference to the general safety and performance
74 requirements . 56
75 Bibliography . 59
76 Terminology — Alphabetized index of defined terms . 60
77
78 Table 201.101— Distributed essential performance requirements . 18
79 Table 201.C.101 — Marking on the outside of an infant cardiorespiratory monitor,
80 its parts or accessories . 36
81 Table 201.C.102 — Accompanying documents, general . 36
82 Table 201.C.103 — Instructions for use . 37
83 Table 201.C.104 — Technical description . 38
84 Table 201.D.2.101 — Additional symbols on marking . 39
85 Table BB.102 — Equipment Identification . 47
86 Table BB.102 — Usage monitoring . 48
87 Table BB.103 — Event information . 48
88 Table BB.108 — Service monitoring . 48
89 Table DD.1 — Correspondence between this document and the
90 IMDRF essential principles . 51
91 Table DD.2 — Correspondence between this document and the
92 IMDRF labelling principles . 52
93 Table EE.1 — Correspondence between this document and the essential principles . 53
94 Table FF.1 — Correspondence between this document and the general safety and
95 performance requirements . 56
96
97

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98 INTERNATIONAL ORGANIZATION for STANDARDISATION
99 ____________
100
101 Respiratory Equipment –Particular requirements for the basic
102 safety and essential performance of equipment for infant
103 cardiorespiratory monitors
104
105 FOREWORD
106 ISO (the International Organization for Standardization) is a worldwide federation of
107 national standards bodies (ISO member bodies). The work of preparing International
108 Standards is normally carried out through ISO technical committees. Each member body
109 interested in a subject for which a technical committee has been established has the right
110 to be represented on that committee. International organizations, governmental and non-
111 governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with
112 the International Electrotechnical Commission (IEC) on all matters of electrotechnical
113 standardization.
114 The procedures used to develop this document and those intended for its further
115 maintenance are described in the ISO/IEC Directives, Part 1. In particular the different
116 approval criteria needed for the different types of ISO documents should be noted. This
117 document was drafted in accordance with the editorial rules of the ISO/IEC Directives,
118 Part 2. www.iso.org/directives
119 Attention is drawn to the possibility that some of the elements of this document may be
120 the subject of patent rights. ISO shall not be held responsible for identifying any or all such
121 patent rights. Details of any patent rights identified during the development of the
122 document will be in the Introduction and/or on the ISO list of patent declarations received.
123 www.iso.org/patents
124 Any trade name used in this document is information given for the convenience of users
125 and does not constitute an endorsement.
126 ISO 18778 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
127 equipment, Subcommittee SC 3, Lung ventilators and related equipment, in collaboration
128 with the European Committee for Standardization (CEN) Technical Committee CEN/TC
129 215, Respiratory and anaesthetic equipment, in accordance with the Agreement on
130 technical cooperation between ISO and CEN (Vienna Agreement). The draft was circulated
131 for voting to the national bodies of ISO.

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oSIST prEN ISO 18778:2021
ISO DIS 80601-2-88  ISO 2021 – 6 –
132 This second edition of ISO 18778, cancels and replaces the first edition of
1
[3]
133 ISO 18778:2005 . This edition of ISO 18778 constitutes a major technical revision of
134 ISO 18778:2005 and includes harmonization with the third edition of IEC 60601-1 and its
135 two amendments, the fourth edition of IEC 60601-1-2 and its amendment, the third edition
136 of IEC 60601-1-6 and its two amendments, the second edition of IEC 60601-1-8 and its two
137 amendments and the second edition of IEC 60601-1-11 and its amendment.
138 The most significant changes are the following modifications:
139 – extending the scope to include the infant cardiorespiratory monitor and its accessories,
140 where the characteristics of those accessories can affect the basic safety or essential
141 performance of the infant cardiorespiratory monitor, and thus not only the infant
142 cardiorespiratory monitor itself;
143 – identification of essential performance of an infant cardiorespiratory monitor and its
144 accessories;
145 and the following additions:
146 – tests for infant cardiorespiratory monitor performance;
147 – tests for mechanical strength (via IEC 60601-1-11);
148 – requirements for transit-operable use;
149 – new symbols;
150 – requirements for an infant cardiorespiratory monitor as a component of an ME system;
151 – tests for enclosure integrity (water ingress via IEC 60601-1-11);
152 – tests for cleaning and disinfection procedures (via IEC 60601-1-11); and
153 – harmonization with ISO 20417.
154

1
 Numbers in square brackets refer to the Bibliography.

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155 INTRODUCTION
156 This document specifies requirements for an infant cardiorespiratory monitor called in
157 previous working documents “infant apnoea monitors or infant monitors”. Infant
158 cardiorespiratory monitors are intended to be used primarily to monitor cardiorespiratory
159 parameters for patients less than 3 years of age. Infant cardiorespiratory monitors are
160 required to include at least one direct measurement of respiration and one indirect
161 measurement of apnoeic activity such as heart rate or oxygen saturation. Infant
162 cardiorespiratory monitors are intended for use in the home healthcare environment. Infant
163 cardiorespiratory monitors are frequently used in locations where supply mains is not
164 reliable. Infant cardiorespiratory monitors are often supervised by non-healthcare
165 personnel (lay operators) with varying levels of training. An infant cardiorespiratory
166 monitor conforming with this document can be used elsewhere (i.e., in healthcare
167 facilities).
168 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
169 In this document, the following print types are used:
170 – Requirements and definitions: roman type
171 – Test specifications and terms defined in clause 3 of the general standard, in this document
172 or as noted: italic type
173 – Informative material appearing outside of tables, such as notes, examples and references: in smaller
174 type. Normative text of tables is also in a smaller type
175 In referring to the structure of this document, the term
176 – “clause” means one of the five numbered divisions within the table of contents,
177 inclusive of all subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);
178 – “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are
179 all subclauses of Clause 201).
180 References to clauses within this document are preceded by the term “Clause” followed by
181 the clause number. References to subclauses within this particular document are by
182 number only.
183 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if
184 any combination of the conditions is true.
185 The verbal forms used in this document conform to usage described in ISO/IEC Directives,
186 Part 2. For the purposes of this document, the auxiliary verb:
187 – “shall” means that conformance with a requirement or a test is mandatory for
188 conformance with this document;
189 – “should” means that conformance with a requirement or a test is recommended but is
190 not mandatory for conformance with this document;
191 – “may” is used to describe permission (e.g. a permissible way to achieve conformance
192 with a requirement or test);
193 – "can" is used to describe a possibility or capability; and

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oSIST prEN ISO 18778:2021
ISO DIS 80601-2-88  ISO 2021 – 8 –
194 – "must" is used to express an external constraint.
195 Annex C contains a guide to the marking and labelling requirements in this document.
196 Annex D contains a summary of the symbols referenced in this document.
197 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table
198 title indicates that there is guidance or rationale related to that item in 0.
199 The ISO and IEC 80601 family of documents are also parts of the IEC 60601 family of
200 documents.
201

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oSIST prEN ISO 18778:2021
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202 Respiratory equipment –Particular requirements for the basic
203 safety and essential performance of equipment for infant
204 cardiorespiratory monitors
205
206 201.1 Scope, object and related standards
207 Clause 1 of the general standard, applies, except as follows.
208 NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
209 201.1.1 Scope
210 Replacement:
211 This document applies to the basic safety and essential performance of an infant
212 cardiorespiratory monitor, as defined in 201.3.203, hereafter also referred to as
213 ME equipment, in combination with its accessories:
214 – intended for use in the home healthcare environment;
215 – intended for use by a lay operator;
216 – intended to monitor cardiorespiratory parameters in sleeping or resting children
217 under three years of age; and
218 – intended for transit-operable use.
219 NOTE 1 An infant cardiorespiratory monitor can also be used in professional health care facilities.
220 This document is also applicable to those accessories intended by their manufacturer to be
221 connected to the infant cardiorespiratory monitor, where the characteristics of those
222 accessories can affect the basic safety or essential performance of the infant
223 cardiorespiratory monitor.
224 EXAMPLE probes, cables distributed alarm system
225 If a clause or subclause is specifically intended to be applicable to ME equipment only, or
226 to ME systems only, the title and content of that clause or subclause will say so. If that is
227 not the case, the clause or subclause applies both to ME equipment and to ME systems, as
228 relevant.
229 Hazards inherent in the intended physiological function of ME equipment or ME systems
230 within the scope of this document are not covered by specific requirements in this
231 document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.
232 NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
233 201.1.2 Object
234 Replacement:

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235 The object of this document is to establish particular basic safety and essential performance
236 requirements for an infant cardiorespiratory monitor, as defined in 201.3.203, and its
237 accessories.
238 Accessories are included because the combination of the infant cardiorespiratory monitor
239 and the accessories needs to be adequately safe. Accessories can have a significant impact
240 on the basic safety or essential performance of the infant cardiorespiratory monitor.
[6] [7]
241 NOTE 1 This document has been prepared to address the relevant essential principles and labelling
242 guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex DD.
243 NOTE 2 This document has been prepared to address the relevant essential principles of safety and
244 performance of ISO 16142-1:2016 as indicated in Annex EE.
245 NOTE 3 This document has been prepared to address the relevant general safety and performance
[8]
246 requirements of European regulation (EU) 2017/745 as indicated in Annex FF.
247 201.1.3 Collateral standards
248 Addition:
249 This document refers to those applicable collateral standards that are listed in Clause 2 of
250 the general standard and Clause 201.2 of this document.
251 IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
252 IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 and IEC 60601-1-11:2015+AMD1:2020
253 apply as modified in Clauses 202, 206, 208 and 211 respectively. IEC 60601-1-3 does not
254 apply. All other published collateral standards in the IEC 60601-1 series apply as
255 published.
256 201.1.4 Particular standards
257 Replacement:
258 In the IEC 60601 series, particular standards define basic safety and essential performance
259 requirements, and may modify, replace or delete requirements contained in the general
260 standard, including the collateral standards as appropriate for the particular
261 ME equipment under consideration.
262 A requirement of a particular standard takes priority over the general standard.
263 For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this particular
264 document as the general standard. Collateral standards are referred to by their document
265 number.
266 The numbering of clauses and subclauses of this document corresponds to that of the
267 general standard with the prefix “201” (e.g. 201.1 in this document addresses the content
268 of Clause 1 of the general standard) or applicable collateral standard with the prefix “2xx”,
269 where xx is the final digits of the collateral standard document number (e.g. 202.4 in this
270 document addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard,
271 211.10 in this document addresses the content of Clause 10 of the IEC 60601-1-11

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272 collateral standard, etc.). The changes to the text of the general standard are specified by
273 the use of the following words:
274 "Replacement" means that the clause or subclause of the general standard or applicable
275 collateral standard is replaced completely by the text of this document.
276 "Addition" means that the text of this document is additional to the requirements of the
277 general standard or applicable collateral standard.
278 "Amendment" means that the clause or subclause of the general standard or applicable
279 collateral standard is amended as indicated by the text of this document.
280 Clauses, subclauses, figures or tables that are additional to those of the general standard
281 are numbered starting from 201.101. However, due to the fact that definitions in the
282 general standard are numbered 3.1 through 3.147, additional definitions in this document
283 are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
284 additional items aa), bb), etc.
285 Subclauses, figures or tables which are additional to those of a collateral standard are
286 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202
287 for IEC 60601-1-2, 208 for IEC 60601-1-8, etc.
288 The term "this document" is used to make reference to the general standard, any
289 applicable collateral standards and t
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