EN ISO 80601-2-72:2023
(Main)Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023)
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023)
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
— intended for use in the home healthcare environment;
— intended for use by a lay operator; and
— intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
Medizinische elektrische Geräte - Teil 2-72: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten für vom Gerät abhängige Patienten (ISO 80601-2-72:2023)
No scope available
Appareils électromédicaux - Partie 2-72: Exigences particulières pour la sécurité de base et les performances essentielles des ventilateurs utilisés dans l'environnement des soins à domicile pour les patients ventilo-dépendants (ISO 80601-2-72:2023)
Le présent document s’applique à la sécurité de base et aux performances essentielles d’un ventilateur associé à ses accessoires, ci-après désignés par appareil EM :
— destiné à être utilisé dans l’environnement des soins à domicile ;
— destiné à être utilisé par un opérateur non spécialiste ; et
— prévu pour les patients qui nécessitent différents niveaux d’aide par ventilation artificielle, y compris pour les patients ventilo-dépendants.
Le présent document s’applique également aux accessoires conçus par leur fabricant pour être raccordés au système respiratoire d’un ventilateur ou à un ventilateur, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles du ventilateur.
Medicinska električna oprema - 2-72. del: Posebne zahteve za osnovno varnost in bistvene lastnosti respiratorjev za oskrbo od aparata odvisnih pacientov na domu (ISO 80601-2-72:2023)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-72:2022
01-junij-2022
Medicinska električna oprema - 2-72. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti respiratorjev za oskrbo od aparata odvisnih pacientov na domu
(ISO/DIS 80601-2-72:2022)
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and
essential performance of home healthcare environment ventilators for ventilator-
dependent patients (ISO/DIS 80601-2-72:2022)
Medizinische elektrische Geräte - Teil 2-72: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten für vom
Gerät abhängige Patienten (ISO/DIS 80601-2-72:2022)
Appareils électromédicaux - Partie 2-72: Exigences particulières pour la sécurité de base
et les performances essentielles des ventilateurs utilisés dans l'environnement des soins
à domicile pour les patients ventilo-dépendants (ISO/DIS 80601-2-72:2022)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-72
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-72:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 80601-2-72:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 80601-2-72:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-72
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-04-26 2022-07-19
Medical electrical equipment —
Part 2-72:
Particular requirements for basic safety and essential
performance of home healthcare environment ventilators
for ventilator-dependent patients
Appareils électromédicaux —
Partie 2-72: Exigences particulières pour la sécurité de base et les performances essentielles des
ventilateurs utilisés dans l'environnement des soins à domicile pour les patients ventilo-dépendants
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 circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 80601-2-72:2022(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 2022
---------------------- Page: 3 ----------------------
oSIST prEN ISO 80601-2-72:2022
© ISO/IEC 2022 – All rights reserved
ISO/DIS 80601-2-72:2022(E)
ISO/TC 121/SC 3/
Date: 2022-02-21
ISO 80601-2-72 (Ed 2)
ISO/IEC TC 121/SC 3/JWG 12
Secretariat: ANSI
Medical electrical equipment — Part 2-72: Particular requirements for
basic safety and essential performance of home healthcare environment
ventilators for ventilator-dependent patients
Appareils électromédicaux — Partie 2-72: Exigences particulières pour la sécurité de base et les
performances essentielles des ventilateurs d'environnement de soins de santé à domicile pour les
patients qui en sont dépendants
DIS stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is
subject to change without notice and may not be referred to as an International Standard.
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.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
1 Contents Page
2 CS will add the contents table at the FDIS stage.
3
4
© ISO 2022 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
5 Foreword
6 ISO (the International Organization for Standardization) is a worldwide federation of national standards
7 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
8 through ISO technical committees. Each member body interested in a subject for which a technical
9 committee has been established has the right to be represented on that committee. International
10 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
11 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
12 electrotechnical standardization.
13 The procedures used to develop this document and those intended for its further maintenance are
14 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
15 different types of ISO documents should be noted. This document was drafted in accordance with the
16 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
17 Attention is drawn to the possibility that some of the elements of this document may be the subject of
18 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
19 patent rights identified during the development of the document will be in the Introduction and/or on
20 the ISO list of patent declarations received (see www.iso.org/patents).
21 Any trade name used in this document is information given for the convenience of users and does not
22 constitute an endorsement.
23 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
24 expressions related to conformity assessment, as well as information about ISO's adherence to the World
25 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
26 www.iso.org/iso/foreword.html.
27 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
28 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care and
29 Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62D, Electric
30 equipment, in collaboration with the European Committee for Standardization (CEN) Technical
31 Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the Agreement on
32 technical cooperation between ISO and CEN (Vienna Agreement).
33 This second edition cancels and replaces the first edition (ISO 80601-2-72:2015), which has been
34 technically revised. The main changes compared to the previous edition are as follows:
35 The most significant changes are the following modifications:
36 — alignment with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020
37 IEC 60601-1-6:2010+AMD1:2013+AMD2:2020, IEC 60601-1-8:2006+AMD1:2012+AMD2:2020
38 and IEC 60601-1-11:2015+AMD1:2020;
39 — reformatted according to most recent Central Secretariat editing rules;
40 — added requirements for display during calibration of gas monitors;
41 — clarified maximum limited pressure requirements;
42 — clarified high airway pressure alarm condition requirements;
43 — added requirements for ventilator system recovery;
44 — added requirements for response to an increase in set oxygen (O ) concentration; and
2
iv © ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
45 — harmonization with ISO 20417, where appropriate.
46 A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
47 Any feedback or questions on this document should be directed to the user’s national standards body. A
48 complete listing of these bodies can be found at www.iso.org/members.html.
49
© ISO 2022 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
50 Introduction
51 This part of ISO 80601 specifies requirements for lung ventilators that are intended for use in the home
52 healthcare environment for patients who are dependent for ventilation for their life support. These
53 ventilators are frequently used in locations where the supply mains driving the ventilator is not reliable.
54 These ventilators are often supervised by non-healthcare personnel (lay operators) with varying levels of
55 training. Lung ventilators conforming with this standard can be used elsewhere (i.e. in healthcare
56 facilities).
57 In referring to the structure of this part of ISO 80601,
58 — “clause” means one of the 5 numbered divisions within the table of contents, inclusive of all
59 subdivisions (e.g. Clause 201 includes 201.7, 201.8, etc.), and
60 — “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all subclauses
61 of Clause 201).
62 References to clauses within this part of ISO 80601 are preceded by the term “Clause” followed by the
63 clause number. References to subclauses within this particular part of ISO 80601 are by number only.
64 In this part of ISO 80601, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
65 combination of the conditions is true.
66 For the purposes of this document, the auxiliary verb:
67 — “shall” indicates a requirement;
68 — “should” indicates a recommendation;
69 — “may” indicates a permission;
70 — "can" is used to describe a possibility or capability; and
71 — "must" is used to express an external constraint.
72 Annex C contains a guide to the marking and labelling requirements in this document.
73 Annex D contains a summary of the symbols referenced in this document.
74 Requirements in this document have been decomposed so that each requirement is uniquely delineated.
75 This is done to support automated requirements tracking.
76
vi © ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
77 Medical electrical equipment — Part 2-72: Particular
78 requirements for basic safety and essential performance of home
79 healthcare environment ventilators for ventilator-dependent
80 patients
81 201.1 Scope, object, and related standards
82 IEC 60601 1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
83 201.1.1 Scope
84 Replacement:
85 NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
86 This part of ISO 80601 applies to the basic safety and essential performance of a ventilator in combination
87 with its accessories, hereafter referred to as ME equipment:
88 — intended for use in the home healthcare environment;
89 NOTE 2 In the home healthcare environment, the supply mains driving the ventilator is often not reliable.
90 NOTE 3 Such ventilators can also be used in non-critical care applications of professional healthcare facilities.
91 — intended for use by a lay operator; and
92 — intended for those patients who need differing levels of support from artificial ventilation including
93 for ventilator-dependent patients.
94 A ventilator is not considered to utilize a physiologic closed-loop control system unless it uses a
95 physiological patient variable to adjust the ventilation therapy settings.
96 This part of ISO 80601 is also applicable to those accessories intended by their manufacturer to be
97 connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories
98 can affect the basic safety or essential performance of the ventilator.
99 EXAMPLE Breathing tubes, connectors, water traps, expiratory valve, humidifier, breathing system filter,
100 external electrical power source, and distributed alarm system.
101 NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only or to ME systems
102 only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies
103 both to ME equipment and to ME systems, as relevant.
104 Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope
105 of this part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in
106 IEC 60601-1:2005+AMD2:2020, 7.2.13 and 8.4.1.
107 NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
108 This part of ISO 80601 does not specify the requirements for:
109 — ventilators or accessories intended for critical care applications, which are given in ISO 80601-2-12;
110 — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13;
111 — ventilators or accessories intended for emergency and transport which are given in ISO 80601-2-84;
© ISO 2022 – All rights reserved 1
---------------------- Page: 9 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
112 — ventilators or accessories intended for homecare ventilatory support equipment (intended only to
113 augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79 and
114 ISO 80601-2-80;
115 — obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;
116 — high-frequency ventilators, which are given in ISO 80601-2-87.
117 — respiratory high-flow therapy equipment, which are given in ISO 80601-2-90;
118 NOTE 6 An ISO 80601-2-72 ventilator can incorporate high-flow therapy operational mode, but such a mode is
119 only for spontaneously breathing patients.
120 — user-powered resuscitators, which are given in ISO 10651-4;
121 — gas-powered emergency resuscitators, which are given in ISO 10651-5;
122 — oxygen therapy constant flow ME equipment; and
123 — cuirass and “iron-lung” ventilators.
124 201.1.2 Object
125 Replacement:
126 The object of this part of ISO 80601 is to establish particular basic safety and essential performance
127 requirements for a ventilator, as defined in 201.3.217, and its accessories.
128 Accessories are included because the combination of the ventilator and the accessories needs to be
129 adequately safe. Accessories can have a significant impact on the basic safety or essential performance of a
130 ventilator.
[31] [32]
131 NOTE 1 This document has been prepared to address the relevant essential principles and labelling guidances
132 of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.
133 NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance of
134 ISO 16142-1:2016 as indicated in Annex DD.
135 NOTE 3 This document has been prepared to address the relevant general safety and performance requirements
[33]
136 of European regulation (EU) 2017/745 as indicated in Annex EE.
137 201.1.3 Collateral standards
138 Amendment (add after existing text):
139 This document refers to those applicable collateral standards that are listed in Clause 2 of the general
140 standard and in 201.2 of this document.
141 NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
142 IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
143 IEC 60601-1-8:2016+AMD1:2012+AMD2:2020 and IEC 60601-1-11:2015+AMD1:2020 apply as
144 modified in Clauses 202, 206, 208 and 211 respectively. IEC 60601-1-3, IEC 60601-1-9 and
145 IEC 60601-1-12 do not apply.
146 201.1.4 Particular standards
147 Replacement:
2 © ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
148 In the IEC 60601 series, particular standards can modify, replace, or delete requirements contained in
149 the general standard, including the collateral standards, as appropriate for the particular ME equipment
150 under consideration, and may add other basic safety or essential performance requirements.
151 A requirement of a particular standard takes priority over IEC 60601-1:2005+AMD1:2012+AMD2:2020
152 or the collateral standards.
153 For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this part of ISO 80601 as the
154 general standard. Collateral standards are referred to by their document number.
155 The numbering of clauses and subclauses of this part of ISO 80601 corresponds to those of the general
156 standard with the prefix “201” (e.g. 201.1 in this part of ISO 80601 addresses the content of Clause 1 of
157 the general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of
158 the collateral standard document number (e.g. 202.4 addresses the content of IEC 60601-1-2, Clause 4
159 collateral standard, 208.4 addresses the content of IEC 60601-1-8, Clause 4 collateral standard, etc.). The
160 changes to the text of the general standard are specified by the use of the following words:
161 — “Replacement” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+AMD2:2020
162 or the applicable collateral standard is replaced completely by the text of this part of ISO 80601.
163 — “Addition” means that the text of this particular standard is additional to the requirements of
164 IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard.
165 — “Amendment” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+AMD2:2020 or
166 the applicable collateral standard is amended as indicated by the text of this part of ISO 80601.
167 Subclauses or figures that are additional to those of the general standard are numbered starting from
168 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through
169 3.154, additional definitions in this document are numbered beginning from 201.3.201. Additional
170 annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
171 Subclauses or figures that are additional to those of a collateral standard are numbered starting from 20x,
172 where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
173 The term “this standard” is used to make reference to IEC 60601-1:2005+AMD1:2012+AMD2:2020, any
174 applicable collateral standards, and this part of ISO 80601 taken together.
175 Where there is no corresponding clause or subclause in this part of ISO 80601, the clause or subclause of
176 IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly not
177 relevant, applies without modification; where it is intended that any part of
178 IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly
179 relevant, is not to be applied, a statement to that effect is given in this part of ISO 80601.
180 201.2 Normative references
181 The following documents, in whole or in part, are normatively referenced in this document and are
182 indispensable for its application. For dated references, only the edition cited applies. For undated
183 references, the latest edition of the referenced document (including any amendments) applies.
184 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
185 Replacement:
186 ISO 15223-1:2021, Medical devices — Symbols to be used with medical device labels, labelling and
187 information to be supplied — Part 1: General requirements
188 IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
189 Addition:
© ISO 2022 – All rights reserved 3
---------------------- Page: 11 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
190 ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
191 ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
192 using sound pressure — Engineering methods for an essentially free field over a reflecting plane
193 ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
194 equipment
195 ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
196 sockets
197 ISO 5359:2008+AMD1:2017, Low-pressure hose assemblies for use with medical gases
1
198 ISO 5367:— , Breathing tubes intended for use with anaesthetic apparatus and ventilators
199 ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed
200 medical gases and vacuum
201 ISO 9360-1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
202 humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
203 ISO 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
204 humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having
205 minimum tidal volumes of 250 ml
206 ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
207 sterilizing agent and the development, validation and routine control of a sterilization process for medical
208 devices
209 ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
210 manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
211 ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
212 manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
213 ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
214 Part 1: Evaluation and testing within a risk management process
215 ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
216 ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
217 to assess filtration performance
218 ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
219 aspects
220 ISO 80369-1:2021, Small-bore connectors for liquids and gases in healthcare applications — Part 1:
221 General requirements
222 ISO 80601-2-55:2018, Medical electrical equipment — Part 2-55: Particular requirements for the basic
223 safety and essential performance of respiratory gas monitors
224 ISO 80601-2-74:2021, Medical electrical equipment — Part 2-74: Particular requirements for basic safety
225 and essential performance of respiratory humidifying equipment
226 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
227 requirements for basic safety and essential performance
228 IEC 62304:2006+AMD1:2015, Medical device software - Software life cycle processes
1
Under preparation. Stage at the time of publication: ISO/FDIS 5367:2022.
4 © ISO 2022 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
229 IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
230 resonance environment
231 IEC 81001-5-1:2021, Health software and health IT systems safety, effectiveness and security — Part 5-1:
232 Security — Activities in the product life cycle
233 IEC Guide 115:2021, Application of uncertainty of measurement to conformity assessment activities in the
234 electrotechnical sector
235 201.3 Terms and definitions
236 For the purposes of this document, the terms and definitions given in
237 IEC 60601-1:2005+AMD1:2012+AMD2:2020, and the following apply.
238 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
239 — ISO Online browsing platform: available at https://www.iso.org/obp
240 — IEC Electropedia: available at http://www.electropedia.org/
241 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 3 applies, except as follows:
242 Addition:
243 201.3.201
244 accompanying information
245 information accompanying or marked on a medical device or accessory for the user or those accountable
246 for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or
247 accessory, particularly regarding safe use
248 Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
249 Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
250 description, installation manual, quick reference guide, etc.
251 Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
252 auditory, visual, or tactile materials and multiple media types (e.g., CD/DVD-ROM, USB stick, website).
253 [SOURCE: ISO 20417:2021, 3.2, modified — deleted note 4.]
254 201.3.202
255 acknowledged
256 state of an alarm system initiated by operator action, where the auditory alarm signal associated with a
257 currently active alarm condition is inactivated until the alarm condition no longer exists or until a
258 predetermined time interval has elapsed
259 Note 1 to entry: Acknowledged only affects alarm signals that are active at the time of the operator action.
260 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.37]
261 201.3.203
262 airway device
263 device intended to provide a gas pathway to and from the patient’s airway
264 [SOURCE: ISO 4135:2021, 3.8.1.2]
© ISO 2022 – All rights reserved 5
---------------------- Page: 13 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
265 201.3.204
266 airway pressure
267 P
aw
268 pressure at the patient-connection port or at the distal outlet of the equipment where there is no patient-
269 connection port
270 Note 1 to entry: The airway pressure can be derived from pressure measurements made anywhere within the
271 equipment.
272 [SOURCE: ISO 4135:2021, 3.1.4.41.1]
273 201.3.205
274 alarm condition delay
275 time from the occurrence of a triggering event either in the patient, for physiological alarm conditions, or
276 in the equipment, for technical alarm conditions, to when the alarm system determines that an alarm
277 condition exists
278 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.2]
279 201.3.206
280 alarm limit
281 threshold used by an alarm system to determine an alarm condition
282 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]
283 201.3.207
284 alarm off
285 state of indefinite duration in which an alarm system or part of an alarm system does not generate alarm
286 signals
287 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.4]
288 201.3.208
289 alarm paused
290 state of limited duration in which the alarm system or part of the alarm system does not generate alarm
291 signals
292 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.5]
293 201.3.209
294 alarm setting
295 alarm system configuration, including but not limited to:
296 – alarm limits;
297 – the characteristics of any alarm signal inactivation states; and
298 – the values of variables or parameters that determine the function of the alarm system
299 Note 1 to entry: Some algorithmically-determined alarm settings can require time to be determined or re-
300 determined.
301 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.8]
302 201.3.210
303 alarm signal generation delay
304 time from the onset of an alarm condition to the generation of its alarm signal(s)
6 © ISO 2022 – All rights reserved
---------------------- Page: 14 ----------------------
oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
305 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.10]
306 201.3.211
307 artificial ventilation
308 intermittent elevation of the pressure in the patient's airway relative to that in the lungs by external
309 means with the intention of augmenting, or totally controlling, the ventilation of a patient
310 EXAMPLE Means used to provide artificial ventilation are manual resuscitation; mouth-to-mouth
311 resuscitation; automatic ventilation; mechanical ventilation.
312 Note 1 to entry: Common classifications of areas of application of artificial ventilation are: emergency; transport;
313 home-care; anaesthesia; critical care; rehabilitation.
314 Note 2 to entry: Classifications used to denote means used for artificial ventilation include: positive-pressure;
315 negative-pressure; gas-powered; operator-powered; electrically-powered.
316 Note 3 to entry: Negative-pressure ventilation elevates the relative pressure in the airway by intermittently
317 lower
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.