FprEN ISO 80601-2-69

SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-69:2024
01-november-2024
Medicinska električna oprema - 2-69. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti naprav za koncentriranje kisika (ISO/DIS 80601-2-69:2024)
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and
essential performance of oxygen concentrator equipment (ISO/DIS 80601-2-69:2024)
Medizinische elektrische Geräte - Teil 2-69: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren
(ISO/DIS 80601-2-69:2024)
Appareils électromédicaux - Partie 2-69: Exigences particulières pour la sécurité de base
et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO/DIS
80601-2-69:2024)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-69
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-69:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 80601-2-69:2024

oSIST prEN ISO 80601-2-69:2024
DRAFT
International
Standard
ISO/DIS 80601-2-69
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-69:
Voting begins on:
Particular requirements for 2024-09-16
the basic safety and essential
Voting terminates on:
2024-12-09
performance of oxygen
concentrator equipment
Appareils électromédicaux —
Partie 2-69: Exigences particulières pour la sécurité de base
et les performances essentielles des dispositifs concentrateurs
d'oxygène
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.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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 80601-2-69:2024(en)
oSIST prEN ISO 80601-2-69:2024
DRAFT
ISO/DIS 80601-2-69:2024(en)
International
Standard
ISO/DIS 80601-2-69
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-69:
Voting begins on:
Particular requirements for
the basic safety and essential
Voting terminates on:
performance of oxygen
concentrator equipment
Appareils électromédicaux —
Partie 2-69: Exigences particulières pour la sécurité de base
et les performances essentielles des dispositifs concentrateurs
d'oxygène
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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 80601-2-69:2024(en)
ii
oSIST prEN ISO 80601-2-69:2024
ISO/DIS 80601-2-69:2024(en)
1 Contents
2 Contents . iii
3 Foreword . v
4 Introduction . vii
5 201. 1 Scope, object and related standards . 1
6 201. 2 Normative references . 3
7 201. 3 Terms and definitions . 5
8 201. 4 General requirements . 17
9 201. 5 General requirements for testing of ME equipment . 18
10 201. 6 Classification of ME equipment and ME systems . 19
11 201. 7 ME equipment identification, marking and documents . 19
12 201. 8 Protection against electrical hazards from ME equipment . 26
13 201. 9 Protection against mechanical hazards of ME equipment and ME systems . 26
14 201. 10 Protection against unwanted and excessive radiation hazards . 29
15 201. 11 Protection against excessive temperatures and other hazards . 29
16 201. 12 Accuracy of controls and instruments and protection against hazardous
17 outputs . 33
18 201. 13 Hazardous situations and fault conditions for ME equipment . 39
19 201. 14 Programmable electrical medical systems (PEMS) . 39
20 201. 15 Construction of ME equipment . 40
21 201. 16 ME systems . 40
22 201. 17 Electromagnetic compatibility of ME equipment and ME systems . 40
23 201.101 Outlet connector . 40
24 201.102 Requirements for parts and accessories . 41
25 201.103 Functional connection . 42
26 201.104 Indication of duration of operation . 43
27 201.105 Integrated conserving equipment function . 43
28 202 Electromagnetic disturbances – Requirements and tests . 43
29 202.4.3.1 Configurations . 44
30 206 Usability . 44
31 211 Requirements for medical electrical equipment and medical electrical systems used
32 in the home healthcare environment . 45
33 211.4.2.2 Environmental operating conditions . 45
34 Annex C (informative) Guide to marking and labelling requirements for ME equipment and
35 ME systems . 46
36 Annex D (informative) Symbols on marking . 51
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37 Annex AA (informative) Particular guidance and rationale . 53
38 Annex BB (informative) Reference to the IMDRF essential principles and labelling
39 guidances . 62
40 Annex CC (informative) Terminology — alphabetized index of defined terms . 67
41 Bibliography . 71
42 Table ZA.2 — Applicable Standards to confer presumption of conformity as described in
43 this Annex ZA . 75
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45 Foreword
46 ISO (the International Organization for Standardization) is a worldwide federation of national standards
47 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
48 through ISO technical committees. Each member body interested in a subject for which a technical
49 committee has been established has the right to be represented on that committee. International
50 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
51 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
52 electrotechnical standardization.
53 The procedures used to develop this document and those intended for its further maintenance are
54 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
55 different types of ISO documents should be noted. This document was drafted in accordance with the
56 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
57 Attention is drawn to the possibility that some of the elements of this document may be the subject of
58 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
59 patent rights identified during the development of the document will be in the Introduction and/or on
60 the ISO list of patent declarations received (see www.iso.org/patents).
61 Any trade name used in this document is information given for the convenience of users and does not
62 constitute an endorsement.
63 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
64 expressions related to conformity assessment, as well as information about ISO's adherence to the World
65 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
66 www.iso.org/iso/foreword.html.
67 This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
68 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
69 Technical Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC D, Particular
70 medical equipment, software, and systems, in collaboration with the European Committee for
71 Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
72 accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
73 This third edition cancels and replaces the second edition (ISO 80601-2-69:2020), which has been
74 technically revised.
75 The main changes compared to the previous edition are as follows:
76 — updated references, where appropriate;
77 — harmonization with ISO 20417, where appropriate;
78 — updated uncertainty of measurement requirements;
79 — added marking requirements for gas intake port, external gas sources and MR compatibility;
80 — requirements for processing of the enclosure;
81 — added cybersecurity recommendations; and
82 — updated connector requirements.
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83 A list of all parts in the ISO and IEC 80601 series can be found on the ISO and IEC websites.
84 Any feedback or questions on this document should be directed to the user’s national standards body. A
85 complete listing of these bodies can be found at www.iso.org/members.html.
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86 Introduction
87 Oxygen supplementation can be part of management of patients with chronic, acute-on-chronic or acute
88 respiratory disorders. The amount of supplemental oxygen depends on the individual patient’s needs
89 under various conditions. The managing healthcare team typically prescribes the endpoint of treatment,
90 for example a target value for oxygen saturation. The amount of supplemental oxygen can be controlled
91 by the flowrate.
92 The goal of long-term oxygen therapy is to keep the oxygen saturation above a target value in patients
93 that require supplemental oxygen. The flowrate should be adjusted for rest, exertion and sleep to meet
94 the individual patient’s needs under these various conditions. Ideally, the resting flowrate is adjusted to
95 maintain SpO greater than the target value as indicated by pulse oximetry.
96 Supplemental oxygen is supplied by various sources: medical gas pipeline systems, oxygen concentrators,
97 compressed gas cylinders and liquid oxygen reservoirs. Oxygen concentrators produce oxygen-enriched
98 air from room air for delivery to a patient requiring oxygen therapy. The most common oxygen
99 concentrator uses molecular sieve beds to filter and concentrate oxygen molecules from the ambient air,
100 generating oxygen concentrations of typically 90 % to 96 %. The main component of this type of oxygen
101 concentrator is the molecular sieve, which adsorbs nitrogen from air to produce a product gas, which is a
102 mixture of typically up to 95 % oxygen and 5 % of other gases. The periodic adsorbing and purging of
103 nitrogen is referred to as the pressure swing adsorption process.
104 Long-term oxygen therapy has been demonstrated in randomized, controlled clinical trials to prolong
105 survival in patients with chronic respiratory disease and documented hypoxemia. Typical sources of
106 therapeutic long-term oxygen therapy include gaseous oxygen from cylinders or from liquid oxygen and
107 oxygen from an oxygen concentrator.
108 In this document, the following print types are used:
109 — requirements and definitions: roman type;
110 — test specifications and terms defined in Clause 3 of the general standard, in this particular document or
111 as noted: italic type; and
112 — informative material appearing outside of tables, such as notes, examples and references: in smaller type.
113 Normative text of tables is also in a smaller type.
114 In referring to the structure of this document, the term.
115 — “clause” means one of the three numbered divisions within the table of contents, inclusive of all
116 subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.); and
117 — “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all subclauses
118 of Clause 201).
119 References to clauses within this document are preceded by the term “Clause” followed by the clause
120 number. References to subclauses within this particular document are by number only.
121 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
122 of the conditions is true.
123 For the purposes of this document, the auxiliary verb:
124 — “shall” indicates a requirement;
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125 — "should” indicates a requirement;
126 — "may” indicates a permission;
127 — "can" indicates a possibility or capability; and
128 — "must" is used to express an external constraint.
129 Annex C contains a guide to the marking and labelling requirements in this document.
130 Annex D contains a summary of the symbols referenced in this document.
131 Requirements in this document have been decomposed so that each requirement is uniquely delineated.
132 This is done to support automated requirements tracking .
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134 Medical electrical equipment
135 Part 2-69:
136 Particular requirements for the basic safety and
137 essential performance of oxygen concentrator equipment
138 201.1 Scope, object and related standards
139 NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
140 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
141 NOTE 2 The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
142 201.1.1 Scope
143 IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.1 is replaced by:
144 This document specifies requirements for the basic safety and essential performance of an oxygen
145 concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to
146 increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen
147 concentrators are typically intended for use in the home healthcare environment by a single patient in
148 various environments including any private and public transportation as well as in commercial aircraft.
149 NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities.
150 This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This
151 document is applicable to an oxygen concentrator integrated into or used with other medical devices,
152 ME equipment or ME systems.

153 EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function.
154 EXAMPLE 2 An oxygen concentrator used with a flowmeter stand.
155 EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies
[2]
156 of electricity and anaesthetic gases .
157 EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system
158 function.
159 This document is also applicable to those accessories intended by their manufacturer to be connected to
160 an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or
161 essential performance of the oxygen concentrator.
162 NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts,
163 carrying cases, external power sources and oxygen conserving equipment.
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164 This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline
165 system.
166 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems
167 only, the title and content of that clause or subclause will say so. If that is not the case, the clause or
168 subclause applies both to ME equipment and to ME systems, as relevant.
169 Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope
170 of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of
171 the general standard.
172 NOTE 3 See also 4.2 of the general standard.
173 201.1.2 Object
174 IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.2 is replaced by:
175 The object of this document is to establish particular basic safety and essential performance requirements
176 for an oxygen concentrator (as defined in 201.3.238) and its accessories.
177 NOTE 1 Accessories are included because the combination of the oxygen concentrator and the accessories needs to
178 be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of an oxygen
179 concentrator.
[11]
180 NOTE 2 This document has been prepared to address the relevant essential principles and labelling
[12]
181 principles guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex BB.
182 NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of
183 ISO 16142-1:2016 as indicated in Annex CC.
184 NOTE 4 This document has been prepared to address the relevant general safety and performance requirements
[10]
185 of European regulation (EU) 2017/745 as indicated in Annex DD.
186 201.1.3 Collateral standards
187 IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:
188 IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 and
189 IEC 60601-1-11:2015+AMD1:2020 apply as modified in Clauses 202, 206 and 211 respectively.
190 IEC 60601-1-3 and IEC 60601-1-9 do not apply. All other published collateral standards in the
191 IEC 60601-1 series apply as published.
192 201.1.4 Particular standards
193 Replacement:
194 In the IEC 60601 series, particular standards define basic safety and essential performance requirements,
195 and may modify, replace or delete requirements contained in the general standard and collateral
196 standards as appropriate for the particular ME equipment under consideration.
197 A requirement of a particular standard takes priority over the general standard.
198 For brevity, IEC 60601-1+AMD1:2012+AMD2:2020 is referred to in this document as the general
199 standard. Collateral standards are referred to by their document number.
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200 The numbering of clauses and subclauses of this document corresponds to that of the general standard
201 with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general
202 standard) or applicable collateral standard with the prefix “20x”, where x is the final digit(s) of the
203 collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of
204 the IEC 60601-1-2 collateral standard, 211.4 in this document addresses the content of Clause 4 of the
205 IEC 60601-1-11collateral standard, etc.). The changes to the text of the general standard are specified by
206 the use of the following words.
207 — "Replacement" means that the clause or subclause of the general standard or applicable collateral
208 standard is replaced completely by the text of this document.
209 — "Addition" means that the text of this document is additional to the requirements of the general
210 standard or applicable collateral standard.
211 — "Amendment" means that the clause or subclause of the general standard or applicable collateral
212 standard is amended as indicated by the text of this document.
213 Clauses, subclauses, figures or tables which are additional to those of the general standard are numbered
214 starting from 201.101. However, due to the fact that definitions in the general standard are numbered
215 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201.
216 Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
217 Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting
218 from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 211 for
219 IEC 60601-1-11, etc.
220 The term "this document" is used to make reference to the general standard, any applicable collateral
221 standards and this particular document taken together.
222 Where there is no corresponding clause or subclause in this document, the clause or subclause of the
223 general standard or applicable collateral standard, although possibly not relevant, applies without
224 modification; where it is intended that any part of the general standard or applicable collateral standard,
225 although possibly relevant, is not to be applied, a statement to that effect is given in this document.
226 201.2 Normative references
227 The following documents are referred to in the text in such a way that some or all of their content
228 constitutes requirements of this document. For dated references, only the edition cited applies. For
229 undated references, the latest edition of the referenced document (including any amendments) applies.
230 IEC 60601-1:2005+AMD1:2012+AMD2: 2020, Clause 2 applies, except as follows:
231 Replacement:
232 ISO 15223-1:2021, Medical devices — Symbols to be used with medical device labels, labelling and
233 information to be supplied — Part 1: General requirements
234 IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
235 Addition:
236 ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
237 using sound pressure — Engineering methods for an essentially free field over a reflecting plane
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238 ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
239 equipment
240 ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed
241 medical gases and vacuum
242 ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
243 sterilizing agent and the development, validation and routine control of a sterilization process for medical
244 devices
245 ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
246 manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
247 ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
248 manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
249 ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
250 Part 1: Evaluation and testing within a risk management process
251 ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
252 ISO 80601-2-67:— , Medical Electrical Equipment — Part 2-67: Particular requirements for basic safety
253 and essential performance of oxygen conserving equipment
254 IEC 60601-1:2005+AMD1:2012+AMD2: 2020, Medical electrical equipment — Part 1: General
255 requirements for basic safety and essential performance
256 IEC 60601-1-2:2014+AMD1:2020, Medical electrical equipment — Part 1-2: General requirements for
257 basic safety and essential performance — Collateral Standard: Electromagnetic disturbances —
258 Requirements and tests
259 IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1-8: General
260 requirements for basic safety and essential performance — Collateral Standard: General requirements,
261 tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
262 IEC 60601-1-11:2015+AMD1:2020, Medical electrical equipment — Part 1-11: General requirements for
263 basic safety and essential performance — Collateral standard: Requirements for medical electrical
264 equipment and medical electrical systems used in the home healthcare environment
265 IEC 62366-1:2015+AMD1:2020, Medical devices – Application of usability engineering to medical devices
266 IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
267 resonance environment
268 IEC Guide 115:2023, Application of uncertainty of measurement to conformity assessment activities in the
269 electrotechnical sector
270 EN 13544-2:2002+AMD1:2009, Respiratory therapy equipment — Part 2: Tubing and connectors

Under preparation. Stage at the time of publication: ISO/DIS 80601-2-67:2024.
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271 201.3 Terms and definitions
272 For the purposes of this document, the terms and definitions given in
273 IEC 60601-1:2005+AMD1:2012+AMD2:2020, and the following apply.
274 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
275 — ISO Online browsing platform: available at https://www.iso.org/obp
276 — IEC Electropedia: available at http://www.electropedia.org/
277 NOTE An index of defined terms is found in Annex EE.
278 Addition:
279 201.3.201
280 accompanying information
281 information accompanying or marked on a medical device or accessory for the user or those accountable
282 for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or
283 accessory, particularly regarding safe use
284 Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
285 Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
286 description, installation manual, quick reference guide, etc.
287 Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
288 auditory, visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).
289 [SOURCE: ISO 20417:2021, 3.2, modified — deleted note 4.]
290 201.3.202
291 alarm condition delay
292 time from the occurrence of a triggering event either in the patient, for physiological alarm conditions, or
293 in the equipment, for technical alarm conditions, to when the alarm system determines that an alarm
294 condition exists
295 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.2]
296 201.3.203
297 alarm limit
298 threshold used by an alarm system to determine an alarm condition
299 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]
300 201.3.204
301 alarm setting
302 alarm system configuration, including but not limited to:
303 – alarm limits;
304 – the characteristics of any alarm signal inactivation states; and
305 – the values of variables or parameters that determine the function of the alarm system
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306 Note 1 to entry: Some algorithmically-determined alarm settings can require time to be determined or re-
307 determined.
308 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.8]
309 201.3.205
310 attack
311 attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized use
312 of an asset
313 [SOURCE: IEC 81001-5-1:2021, 3.5]
314 201.3.206
315 biocompatibility
316 ability to be in contact with a living system without producing an unacceptable adverse effect
317 Note 1 to entry: Medical devices may produce some level of adverse effect, but that level may be determined to be
318 acceptable when considering the benefits provided by the medical device.
319 [SOURCE: ISO 18562-1:2024, 3.6]
320 201.3.207
321 cleaning
322 removal of contaminants to the extent necessary for further processing or for intended use
323 Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances, and other debris)
324 from the surfaces, crevices, serrations, joints, and lumens of a medical device by a manual or automated process that
325 prepares the items for safe handling or further processing.
326 [SOURCE: ISO 17664-2:2021, 3.1, modified — replaced 'and/or' with 'or'.]
327 201.3.208
328 connector
329 fitting to join two or more components
330 EXAMPLE Connectors for low-pressure hose assembly are any of a range of mating components intended to
331 maintain gas specificity by the allocation of a set of different diameters to the mating connectors for each particular
332 gas.
333 [SOURCE: ISO 4135:2022, 3.1.4.5]
334 201.3.209
335 conserving equipment
336 ME equipment intended to conserve supplemental oxygen by delivering gas intermittently and
337 synchronized with the patient's inspiratory cycle
338 Note 1 to entry: Conserving equipment can be electrically or pneumatically powered.
339 [SOURCE: ISO 80601-2-67:—, 201.3.207]
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340 201.3.210
341 continuous flow
342 gas flowing continuously through the breathing system, with a proportion intermittently passing to the
343 patient's lung whenever the airway pressure is raised by the ventilator or an operator action, or flow is
344 demanded by a patient's inspiratory effort
345 Note 1 to entry: For the purposes of this document, ventilator is taken to include oxygen concentrator.
346 [SOURCE: ISO 19223:2019, 3.7.8, modified — deleted notes and added note 1.]
347 201.3.211
348 cybersecurity
349 state where information and systems are protected from unauthorized activities, such as access, use,
350 disclosure, disruption, modification, or destruction to a degree that the related risks to violation of
351 confidentiality, integrity, and availability are maintained at an acceptable level throughout the life cycle
352 [SOURCE: IEC 81001-5-1:2021, 3.30]
353 201.3.212
354 disinfection
355 process to reduce the number of viable microorganisms to a level previously specified as being
356 appropriate for a defined purpose
357 [SOURCE: ISO 17664-1:2021, 3.3]
358 201.3.213
359 distributed alarm system
360 alarm system that involves more than one item of equipment of a ME system intended for delivery of alarm
361 conditions with technical confirmation
362 Note 1 to entry: The parts of a distributed alarm system can be widely separated in distance.
363 Note 2 to entry: A distributed alarm system is intended to notify operators of the existence of an alarm condition.
364 Note 3 to entry: Technical confirmation means that each element of a distributed alarm system confirms or
365 guarantees the successful delivery of the alarm condition to the next element or appropriate technical alarm
366 conditions are created.
367 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.17]
368 201.3.214
369 emergency medical services environment
370 EMS environment
371 actual conditions and settings, in which operators interact with the ME equipment or ME system, in and
372 around the scene of an emergency outside of a professional healthcare facility where a patient can be
373 given medical care, basic or advanced life support as well as during professional transport to a
374 professional healthcare facility or between professional healthcare facilities
oSIST prEN ISO 80601-2-69:2024
ISO/DIS 80601-2-69:2024(en)
375 EXAMPLE 1 Responding to and providing life support at the scene of an emergency to a patient reported as
376 experiencing injury or illness in a pre-hospital setting, and transporting the patient, while continuing such life
377 support care, to an appropriate professional healthcare facility for further care.
378 EXAMPLE 2 Providing monitoring, treatment or diagnosis during transport between professional healthcare
379 facilities.
380 Note 1 to entry: The EMS environment is not considered to be part of the professional healthcare environment.
381 Note 2 to entry: Use of equipment intended for the EMS environment and temporarily used in the home healthcare
382 environment by emergency medical personnel is considered use in the EMS environment.
383 Note 3 to entry: The operators of equipment intended for the EMS environment are presumed to be healthcare
384 professional operators.
385 Note 4 to entry: Emergency medical services are known by various names in different countries and regions.
386 Note 5 to entry: Transport includes road, rotary and fixed-wing ambulances.
387 [SOURCE: IEC 60601-1-12:2014+AMD1:2020, 3.1, modified —replaced “professional medical personnel
388 or personnel with relevant specialized training” with “healthcare professional operators” and replaced
389 original note 3 with new note 1.]
390 201.3.215
391 essential function
392 function or capability that is required to maintain basic safety, essential performance, a minimum of
393 clinical functionality as specified by the manufacturer, and operational availability for the medical device
394 Note 1 to entry: Essential functions include, but are not limited to, the safety instrumented function (basic safety and
395 essential performance), the control function and the availability of urgently needed functions and such allowing the
396 operator to view and manipulate the medical device safely with the most urgently needed performance (operational
397 availability). The loss of essential function is commonly termed loss of protection, loss of control and loss of view
398 respectively.
399 Note 2 to entry: The term is derived from IEC 62443-4-2:2019, 3.1.20, and has been refined for the purpose and
400 scope of this document.
401 [SOURCE: IEC/TR 60601-4-5:2021, 3.10]
402 201.3.216
403 essential principles
404 essential principles of safety and performance
405 fundamental high-level requirements that when complied with ensure a medical device is safe and
406 performs as intended
407 [SOURCE: ISO 16142-1:2016, 3.3]
408 201.3.217
409 exhaust port
410 port through which exhaust gas is discharged to the atmosphere or to an anaesthetic gas scavenging
411 system
412 [SOURCE: ISO 19223:2019, 3.14.2]
oSIST prEN ISO 80601-2-69:2024
ISO/DIS 80601-2-69:2024(en)
413 201.3.218
414 firecall
415 method established to provide emergency access to a secure medical device
416 Note 1 to entry: In an emergency situation, unprivileged users can gain access to key systems to correct the
417 problem. When a firecall is used, there is usually a review process to ensure that the access was used properly to
418 correct a problem. These methods generally either provide a one-time use user identifier (ID) or one-time password
419 or other suitable measures.
420 Note 2 to entry: Also referred to as "break glass" feature.
421 [SOURCE: IEC/TR 60601-4-5:2021, 3.11]
422 201.3.219
423 flow-direction-sensitive component
424 component or accessory through which gas flow is in one direction only for proper functioning or patient
425 safety
426 [SOURCE: ISO 4135:2022, definition 3.1.7, modified — added ‘or accessory’ and “has to be” with “is”.]
427 201.3.220
428 gas intake port
429 port through which gas is drawn for use by the patient
430 Note 1 to entry: Gas is drawn at a sub-ambient pressure at a gas intake port, in opposition to an inlet, at which gas
431 is provided by a medical gas supply system.
432 [SOURCE: ISO 4135:2022, 3.1.4.21, modified — replaced “apposition” with ”opposition”.]
433 201.3.221
434 gas output port
435 port of the ventilator through which gas is delivered at respiratory pressures to an operator-detachable
436 part of a breathing system
437 Note 1 to entry: For the purposes of this document, ventilator is taken to include respiratory high-flow therapy
438 equipment.
439 [SOURCE: ISO 19223:2019, 3.14.3, modified — added note.]
440 201.3.222
441 gas pathway
442 interior surfaces, over which gases or liquids that can be inspired, in a medical device bounded by the
443 ports through which gases or liquids enter and leave the medical device including the patient interface or
444 the interior surfaces of enclosures that are in contact with gases or liquids that can be inspired
445 EXAMPLE 1 The breathing system, inlet filter, gas mixer, blower and internal piping.
446 EXAMPLE 2 Enclosed chamber of an incubator including the mattress or the inner surface of an oxygen hood.
447 EXAMPLE 3 The inner surfaces of breathing tubes, tracheal tubes or masks and mouthpieces.
oSIST prEN ISO 80601-2-69:2024
ISO/DIS 80601-2-69:2024(en)
448 Note 1 to entry: The gas pathway is bounded by the fluid ports through which gases or liquids enter the medical
449 device or accessory. This can include the patient interface or the interior surfaces of enclosures that are in contact
450 with gases or liquids that can be inspired.
451 Note 2 to entry: The gas pathway can include some surfaces in the expiratory pathway.
452 Note 3 to entry: Patient contact surfaces such as the outer surfaces of a tracheal tube or the cushion of a mask are
453 evaluated according to the ISO 10993 series.
454 [SOURCE: ISO 18562-1:2024, 3.11, modified — replaced “ports” with “fluid ports”.]
455 201.3.223
456 home healthcare environment
457 dwelling place in which a patient lives or other places where patients are present, excluding the
458 professional healthcare environment and the EMS environment
459 EXAMPLE Other places include in a car, bus, train, boat or plane, in a wheelchair or walking outdoors.
460 Note 1 to entry: Nursing homes are considered home healthcare environments.
461 Note 2 to entry: In some countries, nursing homes are considered professional healthcare facilities.
462 [SOURCE: IEC 60601-1-11:2015+AMD1:2020, 3.1, modified —deleted notes 1 and 3, modified note 2 as
463 new note 1 and added note 2.]
464 201.3.224
465 humidifier
466 device that adds water in the form of droplets or vapour, or both, to the inspired gas
467 Note 1 to entry: This term includes vaporising, bubble-through and ultrasonic humidifiers and active heat and
468 moisture exchanger
...