oSIST prEN ISO 80601-2-84:2022
(Main)Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO/DIS 80601-2-84:2022)
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO/DIS 80601-2-84:2022)
This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
– intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
– intended to be operated by a healthcare professional operator;
– intended for use in the EMS environment; and
– intended for invasive or non-invasive ventilation.
NOTE 1 An EMS ventilator can also be used for transport within a professional healthcare facility.
* An EMS ventilator is not considered to utilize physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 2 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
This document does not specify the requirements for the following:
– ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
– ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72[3].
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‐2‐13[4].
– ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79[5] and ISO 80601-2-80[6] 1.
– obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70[7].
– operator-powered resuscitators, which are given in ISO 10651‐4[8].
– gas-powered emergency resuscitators, which are given in ISO 10651‐5[9].
– continuous positive airway pressure (CPAP) ME equipment .
– high‐frequency jet ventilators (HFJVs), which are given ISO 80601-2-87[11].
– high‐frequency oscillatory ventilators (HFOVs)[10], which are given ISO 80601-2-87[11].
– NOTE 4 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
– cuirass or “iron‐lung” ventilators.
Medizinische elektrische Geräte - Teil 2-84: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Notfall- und Transportbeatmungsgeräten (ISO/DIS 80601-2-84:2022)
IEC 60601 1:2005+AMD1:2012+AMD2:2020, Abschnitt 1 gilt mit der folgenden Ausnahme:
201.1.1 Anwendungsbereich
Ersatz:
ANMERKUNG 1 Abschnitt AA.2 enthält eine Anleitung oder Begründung für diesen Unterabschnitt.
Dieses Dokument gilt für die Basissicherheit und die wesentlichen Leistungsmerkmale eines EMS-Beatmungsgeräts in Kombination mit seinem Zubehör, im Folgenden auch als ME-Gerät bezeichnet:
— bestimmt für Patienten, die in unterschiedlichem Maße Unterstützung durch künstliche Beatmung benötigen, einschließlich beatmungsabhängiger Patienten;
— bestimmt für die Bedienung durch einen medizinisch ausgebildeten Bediener;
— vorgesehen für die Anwendung in der EMS Umgebung; und
— bestimmt für die invasive oder nicht-invasive Beatmung.
ANMERKUNG 2 Ein EMS-Beatmungsgerät kann auch für den Transport innerhalb einer professionellen Gesundheitseinrichtung verwendet werden.
Bei einem EMS-Beatmungsgerät wird nicht davon ausgegangen, dass es ein physiologisches geschlossenes Regelsystem verwendet, es sei denn, es verwendet eine physiologische Patientenvariable, um die Einstellungen der Beatmungstherapie anzupassen.
Dieses Dokument gilt auch für Zubehör, für das der Hersteller den Anschluss an ein Atemsystem des Beatmungsgeräts oder an ein EMS-Beatmungsgerät vorsieht, bei dem die Merkmale dieses Zubehörs die Basissicherheit und die wesentlichen Leistungsmerkmale des EMS-Beatmungsgeräts beeinflussen können.
ANMERKUNG 3 Ist ein Abschnitt oder Unterabschnitt speziell für die Anwendung nur auf ME Geräten oder nur auf ME Systemen vorgesehen, ist dies aus Überschrift und Inhalt des Abschnitts oder Unterabschnitts ersichtlich. Ist dies nicht der Fall, gilt der Abschnitt oder Unterabschnitt, je nach Zutreffen, für das ME Gerät und das ME System.
Gefährdungen, die der vorgesehenen physiologischen Funktion der in den Anwendungsbereich dieses Dokuments fallenden ME‑Geräte oder ME‑Systeme inhärent sind, werden nicht durch die spezifischen Anforderungen dieses Dokuments abgedeckt, ausgenommen sind IEC 60601 1:2005+AMD2:2020 7.2.13 und 8.4.1.
ANMERKUNG 4 Zusätzliche Angaben können IEC 60601 1:2005+AMD1:2012+AMD2:2020, 4.2, entnommen werden.
Dieses Dokument legt keine Anforderungen an Folgendes fest:
— Beatmungsgeräte oder deren Zubehör für die Intensivpflege von beatmungsabhängigen Patienten, die in ISO 80601 2 12 [17] enthalten sind;
— Beatmungsgeräte oder deren Zubehör für die medizinische Versorgung in häuslicher Umgebung von beatmungsabhängigen Patienten, die in ISO 80601 2 72 [20] enthalten sind;
— Beatmungsgeräte oder deren Zubehör für anästhetische Anwendungen, die in ISO 80601 2 13 [18] sind;
[…]
Appareils électromédicaux - Partie 2-84: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs utilisés dans l'environnement des services médicaux d'urgence (ISO/DIS 80601-2-84:2022)
Medicinska električna oprema - 2-84. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ventilatorjev v okolju nujne medicinske pomoči (ISO/DIS 80601-2-84:2022)
General Information
RELATIONS
Standards Content (sample)
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-84:2022
01-april-2022
Medicinska električna oprema - 2-84. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ventilatorjev v okolju nujne medicinske pomoči (ISO/DIS 80601-
2-84:2022)Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and
essential performance of ventilators for the emergency medical services environment
(ISO/DIS 80601-2-84:2022)Medizinische elektrische Geräte - Teil 2-84: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Notfall- undTransportbeatmungsgeräten (ISO/DIS 80601-2-84:2022)
Appareils électromédicaux - Partie 2-84: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des ventilateurs utilisés dans l'environnement
des services médicaux d'urgence (ISO/DIS 80601-2-84:2022)Ta slovenski standard je istoveten z: prEN ISO 80601-2-84
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.160 Prva pomoč First aid
oSIST prEN ISO 80601-2-84:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80601-2-84:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-84
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-01-25 2022-04-19
Medical electrical equipment —
Part 2-84:
Particular requirements for the basic safety and essential
performance of ventilators for the emergency medical
services environment
Appareils électromédicaux —
Partie 2-84: Exigences particulières relatives à la sécurité de base et aux performances essentielles des
ventilateurs utilisés dans l'environnement des services médicaux d'urgenceICS: 11.040.10
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 80601-2-84:2022(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
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oSIST prEN ISO 80601-2-84:2022
ISO/TC121/SC3/
ISO 80601-2-84:2021 (E)
ISO/DIS 80601-2-84:2022(E)
ISO/TC 121/SC 3/JWG 12
ISO 80601-2-84:2021(Ed 2)
2021-11-22
Secretariat: ANSI
Medical electrical equipment — Part 2-84: Particular
requirements for the basic safety and essential performance of
ventilators for the emergency medical services environment
Appareils électromédicaux — Partie 2-84: Exigences particulières relatives à la sécurité de
base et aux performances essentielles des ventilateurs utilisés dans l'environnement des
services médicaux d'urgenceDIS 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
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Published in Switzerland
© ISO 2022 – All rights reserved
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oSIST prEN ISO 80601-2-84:2022
ISO/DIS 80601-2-84:2022(E)
ISO 80601-2-84:2021(E)
1 Contents
2 Foreword ..................................................................................................................................... vii
3 Introduction .............................................................................................................................. viii
4 201.1 Scope, object and related standards .......................................................................... 1
5 201.1.1 Scope..................................................................................................................... 1
6 201.1.2 Object ................................................................................................................... 2
7 201.1.3 Collateral standards ......................................................................................... 2
8 201.1.4 Particular standards ........................................................................................ 3
9 201.2 Normative references .................................................................................................... 4
10 201.3 Terms and definitions .................................................................................................... 5
11 201.4 General requirements .................................................................................................. 22
12 201.4.3 Essential performance ................................................................................... 22
13 201.4.3.101 Additional requirements for essential performance ............................ 22
14 201.4.3.102 System recovery .............................................................................................. 22
15 201.4.4 Additional requirements for expected service life ................................ 23
16 201.4.5 Alternative risk control measures or test methods for17 ME equipment or ME system ........................................................................ 24
18 201.4.6 ME equipment or ME system parts that contact the patient ............... 24
19 201.4.11.101 Additional requirements for pressurized gas input ............................ 24
20 201.4.11.101.1 Overpressure requirement ..................................................................... 24
21 201.4.11.101.2 Compatibility requirement for medical gas pipeline systems ....... 24
22 201.4.11.101.3 Compatibility requirements for pressure regulators ..................... 25
23 201.5 General requirements for testing of ME equipment ............................................. 25
24 201.5.101 Additional requirements for general requirements for testing25 of ME equipment ............................................................................................. 25
26 201.5.101.1 EMS ventilator test conditions ................................................................... 25
27 201.5.101.2 Gas flowrate and leakage specifications ................................................. 26
28 201.5.101.3 EMS ventilator testing errors ..................................................................... 26
29 201.6 Classification of ME equipment and ME systems .................................................... 26
30 201.7 ME equipment identification, marking and documents ....................................... 26
31 201.7.1.101 Information to be supplied by the manufacturer ................................... 27
32 201.7.2.3 Consult accompanying documents ............................................................. 27
33 201.7.2.4.101 Additional requirements for accessories ................................................. 27
34 201.7.2.18 External gas source ....................................................................................... 27
35 201.7.2.101 Additional requirements for marking on the outside of36 ME equipment or ME equipment parts ..................................................... 28
37 201.7.4.2 Control devices ............................................................................................... 29
38 201.7.4.3 Units of measurement .................................................................................. 29
39 201.7.4.101 Labelling of units of measurement ........................................................... 29
40 201.7.9.2.1 General .............................................................................................................. 29
41 201.7.9.2.1.101 Additional general requirements ......................................................... 29
42 201.7.9.2.2.101 Additional requirements for warnings and safety notices ........... 29
43 201.7.9.2.8.101 Additional requirements for start-up procedure ............................. 30
44 201.7.9.2.9.101 Additional requirements for operating instructions ...................... 31
45 201.7.9.2.12 Cleaning, disinfection, and sterilization ................................................... 32
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46 201.7.9.2.14.101 Additional requirements for accessories, supplementary
47 equipment, used material ............................................................................ 32
48 201.7.9.3.1.101 Additional general requirements ......................................................... 32
49 201.7.9.3.101 Additional requirements for the technical description ....................... 33
50 201.8 Protection against electrical hazards from ME equipment ................................. 33
51 201.9 Protection against mechanical hazards of ME equipment and ME systems ..... 33
52 201.9.4.3.101 Additional requirements for instability from unwanted lateral53 movement ........................................................................................................ 33
54 201.9.4.4 Grips and other handling devices ............................................................. 34
55 201.9.6.2.1.101 Additional requirements for audible acoustic energy.................... 34
56 201.10 Protection against unwanted and excessive radiation hazards ................... 35
57 201.11 Protection against excessive temperatures and other hazards ................... 36
58 201.11.1.2.2 Applied parts not intended to supply heat to a patient ....................... 36
59 201.11.6.6 Cleaning and disinfection of ME equipment or ME system .................. 36
60 201.11.6.7 Sterilization of ME equipment or ME system .......................................... 37
61 201.11.7 Biocompatibility of ME equipment and ME systems .............................. 37
62 201.12 Accuracy of controls and instruments and protection against63 hazardous outputs ........................................................................................................ 37
64 201.12.1.101 Volume-control inflation-type ..................................................................... 37
65 201.12.1.102 Pressure-control inflation-type ................................................................... 41
66 201.12.1.103 Other inflation-types ..................................................................................... 44
67 201.12.1.104 Inspiratory volume monitoring equipment .............................................. 45
68 201.12.4 Protection against hazardous output ....................................................... 45
69 201.12.4.101 Oxygen monitor .............................................................................................. 45
70 201.12.4.102 Measurement of airway pressure .............................................................. 46
71 201.12.4.103 Measurement of expired volume and low volume alarm72 conditions ......................................................................................................... 46
73 201.12.4.104 Maximum limited pressure protection device ......................................... 48
74 201.12.4.105 High airway pressure alarm condition and protection device ............ 48
75 201.12.4.106 Expiratory end-tidal CO monitoring equipment .................................. 49
76 201.12.4.107 Protection against inadvertent setting of high airway pressure ...... 50
77 201.13 Hazardous situations and fault conditions for ME equipment ....................... 50
78 201.13.2.101 Additional specific single fault conditions .............................................. 50
79 201.13.102 Failure of one gas supply to an EMS ventilator ..................................... 51
80 201.13.103 Independence of ventilation control function and related risk81 control measures ............................................................................................ 51
82 201.14 Programmable electrical medical systems (PEMS) ........................................... 51
83 201.14.101 Software life cycle .......................................................................................... 51
84 201.14.102 Cybersecurity capabilities of EMS ventilators ........................................ 52
85 201.15 Construction of ME equipment .............................................................................. 52
86 201.15.3.5.101 Additional requirements for rough handling .................................... 52
87 201.15.4.1 Construction of connectors.......................................................................... 53
88 201.15.101 Mode of operation ......................................................................................... 53
89 201.15.102 Delivered oxygen concentration ............................................................... 53
90 201.15.103 Accessory self-check ...................................................................................... 53
91 201.16 ME systems .................................................................................................................. 54
92 201.16.1.101 Additional general requirements for ME systems ................................. 54
93 201.16.2.101 Additional requirements for power supply ........................................... 54
94 201.17 Electromagnetic compatibility of ME equipment and ME systems................ 54
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95 201.101 Gas connections ........................................................................................................ 54
96 201.101.1 Protection against reverse gas leakage ................................................... 54
97 201.101.2 Connection to a high-pressure inlet .......................................................... 55
98 201.101.2.1 Low-pressure hose assembly ..................................................................... 55
99 201.101.2.2 Filter .................................. ................................................................................ 55
100 201.101.3 VBS connectors ................................................................................................ 55
101 201.101.3.1 General .............................................................................................................. 55
102 201.101.3.2 Other named ports......................................................................................... 55
103 201.101.3.2.1 Patient-connection port ................................................................................ 55
104 201.101.3.2.2 Gas output port and gas return port ......................................................... 56
105 201.101.3.2.3 Flow-direction-sensitive components ........................................................ 56
106 201.101.3.2.4 Accessory port ................................................................................................. 56
107 201.101.3.2.5 Gas exhaust port ............................................................................................. 56
108 201.101.3.2.6 Gas intake port ................................................................................................ 57
109 201.102 Requirements for the VBS and accessories ........................................................ 57
110 201.102.1 General .............................................................................................................. 57
111 201.102.2 Labelling ........................................................................................................... 57
112 201.102.3 Breathing tubes .............................................................................................. 57
113 201.102.4 Water vapour management......................................................................... 58
114 201.102.4.1 Humidification system ................................................................................. 58
115 201.102.4.2 Heat and moisture exchanger (HME) ........................................................ 58
116 201.102.5 Breathing system filters ................................................................................ 58
117 201.102.6 Leakage from complete VBS ........................................................................ 58
118 201.103 Spontaneous breathing during loss of ventilation ........................................... 59
119 201.104 Indication of duration of operation ..................................................................... 59
120 201.105 Functional connection .............................................................................................. 59
121 201.105.1 General .............................................................................................................. 59
122 201.105.2 Connection to an electronic health record ............................................. 60
123 201.105.3 Connection to a distributed alarm system ............................................... 60
124 201.106 Display loops ............................................................................................................. 60
125 201.106.1 Pressure-volume loops ................................................................................. 60
126 201.106.2 Flow-volume loops ........................................................................................ 60
127 201.107 Timed ventilatory pause......................................................................................... 60
128 201.107.1 Expiratory pause ............................................................................................. 61
129 201.107.2 Inspiratory pause ............................................................................................ 61
130 202 Electromagnetic disturbances — Requirements and tests ................................... 62
131 206 Usability ............................................................................................................................. 63
132 206.101 Primary operating functions ....................................................................... 63
133 206.102 Training ............................................................................................................ 65
134 208 General requirements, tests and guidance for alarm systems in medical135 electrical equipment and medical electrical systems ............................................ 65
136 212 Requirements for medical electrical equipment and medical electrical137 systems intended for use in the emergency medical services environment .... 67
138 Annex C (informative) Guide to marking and labelling requirements for139 ME equipment and ME systems ................................................................................... 70
140 201.C.1 Marking on the outside of ME equipment, ME systems or their141 parts ................................................................................................................... 70
142 201.C.2 Accompanying documents, general ............................................................ 71
143 201.C.3 Accompanying documents, instructions for use ...................................... 71
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144 201.C.4 Accompanying documents, technical description ................................... 74
145 Annex D (informative) Symbols on marking ...................................................................... 75
146 Annex AA (informative) Particular guidance and rationale .......................................... 77
147 AA.1 General guidance............................................................................................ 77
148 AA.2 Rationale for particular clauses and subclauses .................................. 77
149 Annex BB (informative) Data interfaces .......................................................................... 111
150 BB.1 Background and purpose ........................................................................... 111
151 BB.2 Data definition .............................................................................................. 112
152 Annex CC (informative) Reference to the IMDRF essential principles and153 labelling guidances .................................................................................................... 119
154 Annex DD (informative) Reference to the essential principles .................................. 123
155 Annex EE (informative) Reference to the general safety and performance156 requirements............................................................................................................... 130
157 Bibliography ............................................................................................................................ 126
158 Terminology — Alphabetized index of defined terms .................................................. 130
159vi © ISO 2021 – All rights reserved
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ISO 80601-2-84:2021(E)
160 Foreword
161 ISO (the International Organization for Standardization) is a worldwide federation of national
162 standards bodies (ISO member bodies). The work of preparing International Standards is
163 normally carried out through ISO technical committees. Each member body interested in a subject
164 for which a technical committee has been estab lished has the right to be represented on that
165 committee. International organizations, governmental and non-governmental, in liaison with ISO,
166 also take part in the work. ISO collaborates closely with the International Electrotechnical
167 Commission (IEC) on all matters of electrotechnical standardization.168 The procedures used to develop this document and those intended for its further maintenance are
169 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed
170 for the different types of ISO documents should be noted. This document was drafted in
171 accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
172 Attention is drawn to the possibility that some of the elements of this document may be the subject
173 of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
174 Details of any patent rights identified during the development of the document will be in the
175 Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).
176 Any trade name used in this document is information given for the convenience of users and does
177 not constitute an endorsement.178 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
179 expressions related to conformity assessment, as well as information about ISO's adherence to the
180 World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
181 www.iso.org/iso/foreword.html.182 This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and
183 respiratory equipment, Subcommittee SC 3, Respiratory devices and related equipment used for
184 patient care, and Technical Committee IEC/TC 62, Electrical equipment in medical practice,
185 Subcommittee 62D, Electromedical equipment, in collaboration with the European Committee for
186 Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment,
187 in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
188 Agreement).189 This second edition cancels and replaces the first edition (ISO 80601-2-84:2020), which has been
190 technically revised. The main changes compared to the previous edition are as follows:
191 — alignment with IEC 60601-1:2005+AMD1:2012+AMD2:2020,192 IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
193 IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, and IEC 60601-1-12:2014+AMD1:2020.
194 — reformatted according to most recent Central Secretariat editing rules;
195 — clarified maximum limited pressure requirements;
196 — added requirements for a responsible organization log.
197 A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
198 Any feedback or questions on this document should be directed to the user’s national standards
199 body. A complete listing of these bodies can be found at www.iso.org/members.html.
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ISO/DIS 80601-2-84:2022(E)
ISO 80601-2-84:2021(E)
200 Introduction
201 In referring to the structure of this document, the term
202 — “clause” means one of the five numbered divisions within the table of contents, inclusive of all
203 subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);204 — “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all
205 subclauses of Clause 201).206 References to clauses within this document are preceded by the term “Clause” followed by the
207 clause number. References to subclauses within this particular document are by number only.
208 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
209 combination of the conditions is true.210 In this document, the following verbal forms are used:
211 — “shall” indicates a requirement;
212 — “should” indicates a recommendation;
213 — “may” indicates a permission;
214 — "can" is used to describe a possibility or capability; and
215 — "must" indicates an external constraint.
216 Annex C contains a guide to the marking and labelling requirements in this document.
217 Annex D contains a summary of the symbols referenced in this document.218 Requirements in this document have been decomposed so that each requirement is uniquely
219 delineated. This is done to support automated requirements tracking.220
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221 Medical electrical equipment —
222 Part 2-84:
223 Particular requirements for the basic safety and essential
224 performance of ventilators for the emergency medical services
225 environment
226 201.1 Scope, object and related standards
227 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
228 201.1.1 Scope
229 Replacement:
230 NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
231 This document applies to the basic safety and essential performance of an EMS ventilator in combination
232 with its accessories, hereafter also referred to as ME equipment:233 intended for patients who need differing levels of support from artificial ventilation including
234 ventilator-dependent patients;235 intended to be operated by a healthcare professional operator;
236 intended for use in the EMS environment; and
237 intended for invasive or non-invasive ventilation.
238 NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.
239 An EMS ventilator is not considered to utilize a physiologic closed loop-control system unless it uses a
240 physiological patient variable to adjust the ventilation therapy settings.241 This document is also applicable to those accessories intended by their manufacturer to be connected to
242 the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can
243 affect the basic safety or essential performance of the EMS ventilator.244 N
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