FprEN ISO 80601-2-12
(Main)Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO/FDIS 80601-2-12:2023)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO/FDIS 80601-2-12:2023)
2022-06-07: BT decided to temporarily remove the link to MDR & M/575 via C088/2022
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege (ISO/FDIS 80601-2-12:2023)
Dieses Dokument gilt für die Basissicherheit und die wesentlichen Leistungsmerkmale von Beatmungsgeräten zusammen mit deren Zubehör, deren Kombination nachfolgend als ME Gerät bezeichnet wird und die:
- vorgesehen sind für den Gebrauch in einer Umgebung, die eine spezielle Pflege für Patienten bietet, deren Zustand lebensgefährlich sein kann und die eine umfassende Pflege sowie ununterbrochene Überwachung in einer professionellen Gesundheitseinrichtung erfordern können;
ANMERKUNG 1 Im Sinne dieses Dokuments wird eine derartige Umgebung eine Intensivpflege-Umgebung genannt. Beatmungsgeräte für diese Umgebung werden als lebenserhaltend erachtet.
ANMERKUNG 2 Im Sinne dieses Dokuments kann ein derartiges Beatmungsgerät den Krankentransport innerhalb einer professionellen Gesundheitseinrichtung ermöglichen (d. h. ein Beatmungsgerät sein, das betriebsfähig bei Bewegung ist).
ANMERKUNG 3 Ein Beatmungsgerät für die Intensivpflege, das für den Krankentransport innerhalb einer professionellen Gesundheitseinrichtung vorgesehen ist, wird nicht als ein in einer Umgebung für den Notfalleinsatz verwendetes Beatmungsgerät betrachtet.
- vorgesehen sind für den Betrieb durch einen medizinisch ausgebildeten Bediener; und
- vorgesehen sind für diejenigen Patienten, die unterschiedliche Unterstützungsniveaus der künstlichen Beatmung benötigen, einschließlich der vom Gerät abhängigen Patienten.
Für ein Beatmungsgerät für die Intensivpflege gilt, dass es kein physiologisches geschlossenes Regelsystem nutzt, solange es keine physiologische Patienten-Größe zum Nachregeln der therapeutischen Beatmungs-Einstellungen verwendet.
Dieses Dokument gilt auch für Zubehör, das vom Hersteller für den Anschluss an ein Beatmungsgerät-Atemsystem oder an ein Beatmungsgerät vorgesehenen ist, wenn die Eigenschaften dieses Zubehörs die Basissicherheit und die wesentlichen Leistungsmerkmale des Beatmungsgeräts beeinträchtigen können.
ANMERKUNG 4 Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf ME-Geräte oder nur auf ME-Systeme vorgesehen, ist dies aus Überschrift und Inhalt des Abschnittes oder Unterabschnittes ersichtlich. Ist das nicht der Fall, trifft der Abschnitt oder Unterabschnitt, wo anwendbar, auf das ME-Gerät und das ME-System zu.
Gefährdungen, die sich aus der vorgesehenen physiologischen Wirkungsweise von ME-Geräten oder ME-Systemen im Anwendungsbereich dieses Dokuments ergeben, sind nicht durch besondere Anforderungen in diesem Dokument erfasst, ausgenommen bei IEC 60601 1:2005+AMD2:2020, 7.2.13 und 8.4.1.
ANMERKUNG 5 Weitere Informationen sind in IEC 60601 1:2005+AMD1:2012+AMD2:2020, 4.2 enthalten.
Dieses Dokument gilt nicht für ME-Geräte und ME-Systeme, die in einer Beatmungsgeräte-Betriebsart arbeiten, die ausschließlich für nicht von künstlicher Beatmung abhängige Patienten vorgesehen sind.
ANMERKUNG 6 Ein Intensivpflege-Beatmungsgerät, das in einer solchen Beatmungsgeräte-Betriebsart benutzt wird, wird nicht als lebenserhaltend angesehen.
Dieses Dokument gilt nicht für ME-Geräte, die in einer professionellen Gesundheitseinrichtung ausschließlich zum Verstärken der Beatmung von spontan atmenden Patienten vorgesehen sind.
[...]
Appareils électromédicaux - Partie 2-12: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs (ISO/FDIS 80601-2-12:2023)
Medicinska električna oprema - 2-12. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ventilatorjev za intenzivno nego (ISO/FDIS 80601-2-12:2022)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-12:2021
01-oktober-2021
Medicinska električna oprema - 2-12. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ventilatorjev za intenzivno nego (ISO/DIS 80601-2-12:2021)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and
essential performance of critical care ventilators (ISO/DIS 80601-2-12:2021)
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die
Intensivpflege (ISO/DIS 80601-2-12:2021)
Appareils électromédicaux - Partie 2-12: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation
en soins intensifs (ISO/DIS 80601-2-12:2021)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-12
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-12:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80601-2-12:2021
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oSIST prEN ISO 80601-2-12:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-12
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-08-03 2021-10-26
Medical electrical equipment —
Part 2-12:
Particular requirements for basic safety and essential
performance of critical care ventilators
Appareils électromédicaux —
Partie 2-12: Exigences particulières relatives à la sécurité de base et aux performances essentielles des
ventilateurs pulmonaires pour utilisation en soins intensifs
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-12:2021(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 80601-2-12:2021
ISO 80601-2-12:2021(E)
ISO/DIS 80601-2-12:2021(E)
1 Contents
2 201.1 Scope, object and related standards. 7
3 201.2 Normative references. 10
4 201.3 Terms and definitions . 12
5 201.4 General requirements . 30
6 201.5 General requirements for testing of ME equipment. 33
7 201.6 Classification of ME equipment and ME systems. 35
8 201.7 ME equipment identification, marking and documents. 35
9 201.8 Protection against electrical hazards from ME equipment . 41
10 201.9 Protection against mechanical hazards of ME equipment and ME systems. 41
11 201.10 Protection against unwanted and excessive radiation hazards. 46
12 201.11 Protection against excessive temperatures and other hazards. 46
13 201.12 Accuracy of controls and instruments and protection against
14 hazardous outputs . 50
15 201.13 Hazardous situations and fault conditions for ME equipment. 68
16 201.14 Programmable electrical medical systems (PEMS) . 70
17 201.15 Construction of ME equipment. 70
18 201.16 ME systems . 74
19 201.17 Electromagnetic compatibility of ME equipment and ME systems . 74
20 201.101 Gas connections . 74
21 201.102 Requirements for the VBS and accessories. 78
22 201.103 Spontaneous breathing during loss of ventilation. 80
23 201.104 Indication of duration of operation. 80
24 201.105 Functional connection . 81
25 201.106 Display loops. 82
26 201.107 Timed ventilatory pause. 82
27 202 Electromagnetic disturbances — Requirements and tests. 84
28 206 Usability. 85
29 208 General requirements, tests and guidance for alarm systems in
30 medical electrical equipment and medical electrical systems. 87
31 Annex C (informative) Guide to marking and labelling requirements for ME equipment
COPYRIGHT PROTECTED DOCUMENT
32 and ME systems. 90
© ISO 2021
33 Annex D (informative) Symbols on marking . 95
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
34 Annex AA (informative) Particular guidance and rationale . 97
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
35 Annex BB (informative) Data interfaces . 135
below or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 80601-2-12:2021
ISO/DIS 80601-2-12:2021(E)
1 Contents
2 201.1 Scope, object and related standards. 7
3 201.2 Normative references . 10
4 201.3 Terms and definitions . 12
5 201.4 General requirements . 30
6 201.5 General requirements for testing of ME equipment . 33
7 201.6 Classification of ME equipment and ME systems . 35
8 201.7 ME equipment identification, marking and documents . 35
9 201.8 Protection against electrical hazards from ME equipment . 41
10 201.9 Protection against mechanical hazards of ME equipment and ME systems. 41
11 201.10 Protection against unwanted and excessive radiation hazards . 46
12 201.11 Protection against excessive temperatures and other hazards . 46
13 201.12 Accuracy of controls and instruments and protection against
14 hazardous outputs . 50
15 201.13 Hazardous situations and fault conditions for ME equipment . 68
16 201.14 Programmable electrical medical systems (PEMS) . 70
17 201.15 Construction of ME equipment . 70
18 201.16 ME systems . 74
19 201.17 Electromagnetic compatibility of ME equipment and ME systems . 74
20 201.101 Gas connections . 74
21 201.102 Requirements for the VBS and accessories. 78
22 201.103 Spontaneous breathing during loss of ventilation . 80
23 201.104 Indication of duration of operation . 80
24 201.105 Functional connection . 81
25 201.106 Display loops . 82
26 201.107 Timed ventilatory pause . 82
27 202 Electromagnetic disturbances — Requirements and tests . 84
28 206 Usability . 85
29 208 General requirements, tests and guidance for alarm systems in
30 medical electrical equipment and medical electrical systems . 87
31 Annex C (informative) Guide to marking and labelling requirements for ME equipment
32 and ME systems . 90
33 Annex D (informative) Symbols on marking . 95
34 Annex AA (informative) Particular guidance and rationale . 97
35 Annex BB (informative) Data interfaces . 135
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oSIST prEN ISO 80601-2-12:2021
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ISO 80601-2-12:2021(E)
36 Annex CC (informative) Reference to the IMDRF essential principles and
37 labelling guidances . 144
38 Annex DD (informative) Reference to the essential principles . 147
39 Annex EE (informative) Reference to the general safety and performance requirements
40 . 150
41 Bibliography . 153
42 Terminology — Alphabetized index of defined terms . 158
43
44 Figures
45 Figure 201.101 — Typical closed suctioning test setup . 44
46 Figure 201.102 — Typical test setup for volume- and pressure-control
47 inflation-type accuracy . 52
48 Figure 201.103 — Oxygen concentration change test setup . 59
49 Figure AA.1 — Pressure drop calculation for 3,0 mm ETT, 100 % RH room
50 air at sea level, 37°C, using approach specified in Reference [57] . 115
51 Figure AA.2 — Pressure waveforms as a function of time during
52 volume-controlled breath delivery to a patient with acute severe asthma . 121
53 Figure AA.3 — VBS leakage flowrate limits as a function of pressure as
[19]
54 specified in ISO 80601-2-12 and ISO 80601-2-13 . 131
55
56 Tables
57 201. Table 201.101 — Distributed essential performance requirements . 31
58 Table 201.102 — Test conditions for acoustic tests . 43
59 Table 201.103 — Examples of permissible combinations of temperature and relative
60 humidity 46
61 Table 201.104 — Volume-control inflation-type testing . 53
62 Table 201.105 — Pressure-control inflation-type testing . 56
63 Table 201.106 — Test conditions for oxygen concentration change tests . 59
64 Table 201.C.101 — Marking on the outside of a ventilator, its parts
65 or accessories . 90
66 Table 201.C.102 — Accompanying documents, general . 91
67 Table 201.C.103 — Instructions for use . 91
68 Table 201.C.104 — Technical description . 94
69 Table 201.D.2.101 — Additional symbols on marking . 95
70 Table AA.1 — Flow and pressure drop for linear and parabolic resistors . 115
71 Table AA.2 — Flow and pressure drop for linear and parabolic resistors . 116
72 Table AA.3 — Calculated conductance values by tidal volume range . 130
73 Table BB.101 — Parameters and units of measurement . 136
74 Table BB.102 — Equipment identification . 137
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75 Table BB.103 — Usage monitoring . 137
76 Table BB.104 — Equipment settings . 138
77 Table BB.105 — Ventilation monitoring . 141
78 Table BB.106 — Ventilator alarm limits . . 142
79 Table BB.107 — Event information . 143
80 Table BB.108 —Service monitoring . 143
81 Table CC.1 — Correspondence between this document and the essential
82 principles 144
83 Table CC.2 — Correspondence between this document and the labelling
84 principles . 146
85 Table DD.1 — Correspondence between this document and the essential
86 principles 147
87 Table EE.1 — Correspondence between this document and the general
88 safety and performance requirements . 150
89
90
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oSIST prEN ISO 80601-2-12:2021
ISO/DIS 80601-2-12:2021(E)
ISO 80601-2-12:2021(E)
91 Foreword
92 ISO (the International Organization for Standardization) is a worldwide federation of national standards
93 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
94 through ISO technical committees. Each member body interested in a subject for which a technical
95 committee has been established has the right to be represented on that committee. International
96 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
97 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
98 electrotechnical standardization.
99 The procedures used to develop this document and those intended for its further maintenance are
100 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
101 different types of ISO documents should be noted. This document was drafted in accordance with the
102 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
103 Attention is drawn to the possibility that some of the elements of this document may be the subject of
104 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
105 patent rights identified during the development of the document will be in the Introduction and/or on
106 the ISO list of patent declarations received (see www.iso.org/patents).
107 Any trade name used in this document is information given for the convenience of users and does not
108 constitute an endorsement.
109 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
110 expressions related to conformity assessment, as well as information about ISO's adherence to the World
111 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
112 www.iso.org/iso/foreword.html.
113 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
114 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care and
115 Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62D, Electric
116 equipment, in collaboration with the European Committee for Standardization (CEN) Technical
117 Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the Agreement on
118 technical cooperation between ISO and CEN (Vienna Agreement).
119 This third edition cancels and replaces the second edition (ISO 80601-2-12:2020), which has been
120 technically revised. The main changes compared to the previous edition are as follows:
121 — alignment with IEC 60601-1:2005+AMD1:2012+AMD2:2020,
122 IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020 and IEC 60601-
123 1-6:2010+AMD1:2013+AMD2:2020.
124 — reformatted according to most recent Central Secretariat editing rules;
125 — added requirements for the display legibility for operators wearing personal protective equipment;
126 — added requirements for display during calibration of gas monitors;
127 — clarified maximum limited pressure requirements;
128 — clarified high airway pressure alarm condition requirements;
129 — added requirements for ventilator system recovery; and
130 — harmonization with ISO 20417, where appropriate.
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oSIST prEN ISO 80601-2-12:2021
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ISO 80601-2-12:2021(E)
131 A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
132 Any feedback or questions on this document should be directed to the user’s national standards body. A
133 complete listing of these bodies can be found at www.iso.org/members.html.
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oSIST prEN ISO 80601-2-12:2021
ISO/DIS 80601-2-12:2021(E)
ISO 80601-2-12:2021(E)
134 Introduction
135 In referring to the structure of this document, the term
136 — “clause” means one of the four numbered divisions within the table of contents, inclusive of all
137 subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);
138 — “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.12 are all
139 subclauses of Clause 201).
140 References to clauses within this document are preceded by the term “Clause” followed by the clause
141 number. References to subclauses within this document are by number only.
142 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
143 of the conditions is true.
144 In this document, the following verbal forms are used:
145 — “shall” indicates a requirement;
146 — “should” indicates a recommendation;
147 — “may” indicates a permission;
148 — "can" is used to describe a possibility or capability.
149 Annex C contains a guide to the marking and labelling requirements in this document.
150 Annex D contains a summary of the symbols referenced in this document.
151 Requirements in this document have been decomposed so that each requirement is uniquely delineated.
152 This is done to support automated requirements tracking.
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ISO 80601-2-12:2021(E)
153 Medical electrical equipment — Part 2-12: Particular
154 requirements for basic safety and essential performance of
155 critical care ventilators
156 201.1 Scope, object and related standards
157 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
158 201.1.1 Scope
159 Replacement:
160 NOTE 1 There is guidance or rationale for this subclause contained in Clause A.2.
161 This document applies to the basic safety and essential performance of a ventilator in combination with
162 its accessories, hereafter referred to as ME equipment:
163 intended for use in an environment that provides specialized care for patients whose conditions can
164 be life-threatening and who can require comprehensive care and constant monitoring in a
165 professional healthcare facility;
166 NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment.
167 Ventilators for this environment are considered life-sustaining.
168 NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional
169 healthcare facility (i.e. be a transit-operable ventilator).
170 NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not
171 considered as an emergency medical services environment ventilator.
172 intended to be operated by a healthcare professional operator; and
173 intended for those patients who need differing levels of support from artificial ventilation including
174 for ventilator-dependent patients.
175 A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses
176 a physiological patient variable to adjust the ventilation therapy settings.
177 This document is also applicable to those accessories intended by their manufacturer to be connected to
178 a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect
179 the basic safety or essential performance of the ventilator.
180 NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems
181 only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies
182 both to ME equipment and to ME systems, as relevant.
183 Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope
184 of this document are not covered by specific requirements in this document except in IEC 60601-
185 1:2005+AMD2:2020, 7.2.13 and 8.4.1.
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186 NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
187 This document is not applicable to ME equipment or ME system operating in a ventilator-operational mode
188 solely intended for patients who are not dependent on artificial ventilation.
189 NOTE 6 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-
190 sustaining.
191 This document is not applicable to ME equipment that is intended solely to augment the ventilation of
192 spontaneously breathing patients within a professional healthcare facility.
193 This document does not specify the requirements for:
194 ventilators or accessories intended for anaesthetic applications, which are given in
[19]
195 ISO 80601-2-13 ;
196 ventilators or accessories intended for the emergency medical services environment, which are given
[24]
197 in ISO 80601-2-84 ;
198 ventilators or accessories intended for ventilator-dependent patients in the home healthcare
[21]
199 environment, which are given in ISO 80601-2-72 ;
200 ventilators or accessories intended for home-care ventilatory support devices, which are given in
[22] [23]
201 ISO 80601-2-79 and ISO 80601-2-80 ;
[20]
202 obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70 ;
203 continuous positive airway pressure (CPAP) ME equipment;
[25]
204 high-frequency ventilators, which are given in ISO 80601-2-87 ;
205 NOTE 7 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-
206 operational modes.
[26]
207 respiratory high-flow therapy equipment, which are given in ISO 80601-2-90 ;
208 oxygen therapy constant flow ME equipment; and
209 cuirass or “iron-lung” ventilation equipment.
210 201.1.2 Object
211 Replacement:
212 The object of this document is to establish basic safety and essential performance requirements for a
213 ventilator and its accessories.
214 Accessories are included because the combination of the ventilator and the accessories needs to be
215 adequately safe. Accessories can have a significant impact on the basic safety or essential performance of a
216 ventilator.
[39] [40]
217 NOTE 1 This document has been prepared to address the relevant essential principles and labelling
218 guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.
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219 NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance of
220 ISO 16142-1:2016 as indicated in Annex DD.
221 NOTE 3 This document has been prepared to address the relevant general safety and performance requirements
222 of European regulation (EU) 2017/745 as indicated in Annex EE.
223 201.1.3 Collateral standards
224 Amendment (add after existing text):
225 This document refers to those applicable collateral standards that are listed in Clause 2 of the general
226 standard and in 201.2 of this document.
227 NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
228 IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 and
229 IEC 60601-1-8:201
...
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