Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

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 a 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 in ISO 80601-2-87[11].
- high‐frequency oscillatory ventilators (HFOVs)[10], which are given in 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.
[1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.

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

Le présent document s'applique à la sécurité de base et aux performances essentielles d'un ventilateur SMU associé à ses accessoires, appelés ci-après appareil EM:
- destinés aux patients ayant besoin de différents niveaux d'assistance respiratoire artificielle, y compris aux patients ventilo-dépendants;
- destinés à être utilisés par un opérateur professionnel de soins de santé;
- destinés à être utilisés dans l'environnement SMU; et
- destinés à la ventilation invasive ou non invasive.
NOTE 1 Un ventilateur SMU peut également être utilisé lors d'un transport dans un établissement de santé.
* Un ventilateur SMU n'est pas censé utiliser de système physiologique de commande en boucle fermée, sauf s'il utilise une variable physiologique du patient pour ajuster les paramètres de thérapie respiratoire.
Le présent document s'applique également aux accessoires conçus par leur fabricant pour être connectés au système respiratoire du ventilateur, ou à un ventilateur SMU, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base et les performances essentielles du ventilateur SMU.
NOTE 2 Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de l'IEC 60601-1:2005, 7.2.13 et 8.4.1.
NOTE 3 Des informations supplémentaires peuvent être trouvées dans l'IEC 60601-1:2005+AMD1:2012, 4.2.
Le présent document ne spécifie pas les exigences applicables:
- aux ventilateurs ou accessoires prévus pour les patients ventilo-dépendants dans les applications de soins intensifs. Celles-ci sont données dans l'ISO 80601-2-12;
- aux ventilateurs ou accessoires prévus pour les patients ventilo-dépendants dans l'environnement des soins à domicile. Celles-ci sont données dans l'ISO 80601-2-72[3];
- aux ventilateurs ou accessoires prévus pour des applications anesthésiques. Celles-ci sont données dans l'ISO 80601‐2‐13[4];
- aux ventilateurs ou accessoires prévus pour les équipements d'assistance respiratoire (uniquement destinés à augmenter la ventilation des patients respirant spontanément). Celles-ci sont données dans l'ISO 80601‑2-79[5] et dans l'ISO 80601-2-80[6] [1]);
- aux appareils EM de traitement de l'apnée du sommeil. Celles-ci sont données dans l'ISO 80601‑2‑70[7];
- aux ressuscitateurs à puissance motrice manuelle. Celles-ci sont données dans l'ISO 10651‐4[8];
- aux appareils de réanimation d'urgence alimentés par gaz. Celles-ci sont données dans l'ISO 10651‑5[9];
- aux appareils EM délivrant une pression continue (CPAP);
- aux ventilateurs de jet haute fréquence (VJHF). Celles-ci sont données dans l'ISO 80601-2-87[11];
- aux ventilateurs à oscillation haute fréquence (VOHF)[10]. Celles-ci sont données dans l'ISO 80601‑2‑87[11];
NOTE 4 Un ventilateur SMU peut incorporer des modes de ventilation à jet haute fréquence ou à oscillation haute fréquence.
- aux cuirasses ou «poumons d'acier».
[1]) L'ISO 80601-2-79 et l'ISO 80601-2-80 remplacent l'ISO 10651-6, qui a été retirée.

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Published
Publication Date
20-Jul-2020
Current Stage
PPUB - Publication issued
Completion Date
27-Jul-2020
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INTERNATIONAL ISO
STANDARD 80601-2-84
First edition
2020-07
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'urgence
Reference number
ISO 80601-2-84:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 80601-2-84:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 80601-2-84:2020(E)
Contents

Foreword ...................................................................................................................................... vi

Introduction .............................................................................................................................. viii

201.1 Scope, object and related standards .......................................................................... 1

201.1.1 * Scope.................................................................................................................. 1

201.1.2 Object ................................................................................................................... 2

201.1.3 Collateral standards ......................................................................................... 2

201.1.4 Particular standards ........................................................................................ 3

201.2 Normative references .................................................................................................... 4

201.3 Terms and definitions .................................................................................................... 6

201.4 General requirements .................................................................................................... 6

201.4.3 Essential performance ...................................................................................... 6

201.4.3.101 * Additional requirements for essential performance ............................ 6

201.4.4 Additional requirements for expected service life ................................... 7

201.4.6 * ME equipment or ME system parts that contact the patient ............... 7

201.4.11.101 * Additional requirements for pressurized gas input ........................... 7

201.4.11.101.1 Overpressure requirement ........................................................................ 7

201.4.11.101.2 Compatibility requirement for medical gas pipeline systems .......... 8

201.4.11.101.3 Compatibility requirements for pressure regulators ........................ 8

201.5 General requirements for testing of ME equipment ............................................... 9

201.5.101 * Additional requirements for general requirements for testing

of ME equipment ................................................................................................ 9

201.5.101.1 EMS ventilator test conditions ...................................................................... 9

201.5.101.2 * Gas flowrate and leakage specifications ................................................. 9

201.5.101.3 * EMS ventilator testing errors ..................................................................... 9

201.6 Classification of ME equipment and ME systems ...................................................... 9

201.7 ME equipment identification, marking and documents ......................................... 9

201.7.2.3 * Consult accompanying documents ............................................................. 9

201.7.2.4.101 Additional requirements for accessories ............................................... 10

201.7.2.13.101 Additional requirements for physiological effects .......................... 10

201.7.2.17.101 Additional requirements for protective packaging ......................... 10

201.7.2.18 External gas source ....................................................................................... 10

201.7.2.101 * Additional requirements for marking on the outside of

ME equipment or ME equipment parts ..................................................... 11

201.7.4.2 * Control devices ............................................................................................ 12

201.7.4.3 * Units of measurement ............................................................................... 12

201.7.4.101 Labelling of units of measurement ........................................................... 12

201.7.9.1 Additional general requirements .............................................................. 12

201.7.9.2.1.101 Additional general requirements ........................................................ 12

201.7.9.2.2.101 * Additional requirements for warnings and safety notices........ 13

201.7.9.2.8.101 * Additional requirements for start-up procedure ......................... 13

201.7.9.2.9.101 * Additional requirements for operating instructions .................. 14

201.7.9.2.12 Cleaning, disinfection, and sterilization ................................................... 15

201.7.9.2.14.101 * Additional requirements for accessories, supplementary

equipment, used material……. .................................................................... 15

201.7.9.3.1.101 * Additional general requirements ..................................................... 15

201.7.9.3.101 Additional requirements for the technical description .................... 16

201.8 Protection against electrical hazards from ME equipment ................................. 16

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ISO 80601-2-84:2020(E)

201.9 Protection against mechanical hazards of ME equipment and ME systems ..... 16

201.9.4.3.101 * Additional requirements for instability from unwanted

lateral movement……………….. ..................................................................... 16

201.9.4.4 Grips and other handling devices ............................................................. 17

201.9.6.2.1.101 Additional requirements for audible acoustic energy ................... 17

201.10 Protection against unwanted and excessive radiation hazards ................... 18

201.11 Protection against excessive temperatures and other hazards ................... 18

201.11.1.2.2 * Applied parts not intended to supply heat to a patient .................... 18

201.11.6.6 * Cleaning and disinfection of ME equipment or ME system ............... 19

201.11.6.7 Sterilization of ME equipment or ME system .......................................... 20

201.11.7 Biocompatibility of ME equipment and ME systems .............................. 20

201.12 Accuracy of controls and instruments and protection against

hazardous outputs ........................................................................................................ 21

201.12.1.101 * Volume-control inflation-type ................................................................. 21

201.12.1.102 * Pressure-controlled inflation-type ........................................................ 24

201.12.1.103 Other inflation-types…………… .................................................................... 27

201.12.1.104 Inspiratory volume monitoring equipment ............................................. 28

201.12.4 Protection against hazardous output ....................................................... 28

201.12.4.101 Oxygen monitor………………… ...................................................................... 28

201.12.4.102 * Measurement of airway pressure .......................................................... 29

201.12.4.103 * Measurement of expired volume and low volume alarm

conditions…………………………… ..................................................................... 30

201.12.4.104 * Maximum limited pressure protection device ..................................... 31

201.12.4.105 * High airway pressure alarm condition and protection device ........ 31

201.12.4.106 * Expiratory end-tidal CO monitoring equipment .............................. 33

201.12.4.107 Protection against inadvertent setting of high airway pressure ..... 33

201.13 Hazardous situations and fault conditions for ME equipment ....................... 33

201.13.2.101 * Additional specific single fault conditions .......................................... 33

201.13.102 Failure of one gas supply to an EMS ventilator ..................................... 34

201.13.103 * Independence of ventilation control function and related risk

control measures ............................................................................................ 34

201.14 Programmable electrical medical systems (PEMS) ........................................... 35

201.14.101 Software life cycle .......................................................................................... 35

201.15 Construction of ME equipment .............................................................................. 35

201.15.3.5.101 * Additional requirements for rough handling ................................. 35

201.15.4.1 Construction of connectors ......................................................................... 36

201.15.101 Mode of operation ......................................................................................... 36

201.15.102 * Delivered oxygen concentration ............................................................ 36

201.15.103 Accessory self-check ...................................................................................... 36

201.16 ME systems .................................................................................................................. 36

201.16.1.101 Additional general requirements for ME systems ................................ 36

201.16.3.101 Additional requirements for power supply .......................................... 37

201.17 Electromagnetic compatibility of ME equipment and ME systems................ 37

201.101 Gas connections ....................................................................................................... 37

201.101.1 * Protection against reverse gas leakage ................................................ 37

201.101.2 Connection to a high-pressure input port ................................................ 37

201.101.2.1 Connector………………………….. ...................................................................... 37

201.101.2.2 * Filter……………………………….. ...................................................................... 37

201.101.3 VBS connectors ............................................................................................... 38

201.101.3.1 * General…………………… .................................................................... 38

iv © ISO 2020 – All rights reserved
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ISO 80601-2-84:2020(E)

201.101.3.2 Other named ports………… ............................................................... 38

201.101.3.2.1 Patient-connection port ................................................................ 38

201.101.3.2.2 Gas output port and gas return port .......................................... 38

201.101.3.2.3 Flow-direction-sensitive components ........................................ 38

201.101.3.2.4 * Accessory port…………….. ............................................................ 39

201.101.3.2.5 Gas exhaust por…………………. ....................................................... 39

201.102 Requirements for the VBS and accessories ....................................................... 39

201.102.1 * General ........................................................................................................... 39

201.102.2 Labelling ........................................................................................................... 39

201.102.3 Breathing tubes .............................................................................................. 40

201.102.4 * Water vapour management ..................................................................... 40

201.102.4.1 * Humidification system .................................................................. 40

201.102.4.2 Heat and moisture exchanger (HME) ............................................ 40

201.102.5 Breathing system filters ................................................................................ 40

201.102.6 * Leakage from complete VBS ..................................................................... 40

201.103 Spontaneous breathing during loss of power supply..................................... 41

201.104 * Indication of duration of operation ................................................................. 41

201.105 Functional connection ............................................................................................. 41

201.105.1 General .............................................................................................................. 41

201.105.2 * Connection to an electronic health record .......................................... 42

201.105.3 * Connection to a distributed alarm system ............................................ 42

201.106 Display loops ............................................................................................................ 42

201.106.1 Pressure-volume loops ................................................................................. 42

201.106.2 Flow-volume loops ........................................................................................ 42

201.107 Timed ventilatory pause ....................................................................................... 43

201.107.1 Expiratory pause ............................................................................................. 43

201.107.2 Inspiratory pause ............................................................................................ 43

202 Electromagnetic disturbances — Requirements and tests ................................... 44

206 Usability ............................................................................................................................. 45

206.101 Primary operating functions ....................................................................... 45

206.102 * Training ......................................................................................................... 47

208 General requirements, tests and guidance for alarm systems in medical

electrical equipment and medical electrical systems ......................................... 47

212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services

environment ................................................................................................................... 48

Annex C (informative) Guide to marking and labelling requirements for

ME equipment and ME systems ................................................................................... 51

Annex D (informative) Symbols on marking ..................................................................... 56

Annex AA (informative) Particular guidance and rationale .......................................... 58

Annex BB (informative) Data interfaces ............................................................................. 92

Annex CC (informative) Reference to the essential principles ................................... 100

Annex DD (informative) Terminology — Alphabetized index of defined terms ... 103

Bibliography ............................................................................................................................ 108

© ISO 2020 – All rights reserved v
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ISO 80601-2-84:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national

standards bodies (ISO member bodies). The work of preparing International Standards is

normally carried out through ISO technical committees. Each member body interested in a subject

for which a technical committee has been established has the right to be represented on that

committee. International organizations, governmental and non-governmental, in liaison with ISO,

also take part in the work. ISO collaborates closely with the International Electrotechnical

Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed

for the different types of ISO documents should be noted. This document was drafted in

accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject

of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

Details of any patent rights identified during the development of the document will be in the

Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does

not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see

www.iso.org/iso/foreword.html.

This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and

respiratory equipment, Subcommittee SC 3, Respiratory devices and related equipment used

for patient care, and Technical Committee IEC/TC 62, Electrical equipment in medical

practice, Subcommittee 62D, Electromedical equipment.

This first edition cancels and replaces ISO 10651-3:1997, which has been technically

revised. The main changes compared to the previous edition are as follows:

— extension of the scope to include the EMS ventilator and its accessories, where the

characteristics of those accessories can affect the basic safety or essential performance

of the ventilator for the emergency medical services environment, and thus not only the

ventilator for the emergency medical services environment itself;

— identification of essential performance for ventilator for the emergency medical services

environment and its accessories;
— modification of the tests for environmental conditions (via IEC 60601-1-12);
— modification of the tests for alarm conditions (via IEC 60601-1-8);

— modification of the tests for electromagnetic disturbances (via IEC 60601-1-2);

— addition of the following:
— tests for ventilation performance;
— test for instability from unwanted lateral movement;
vi © ISO 2020 – All rights reserved
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ISO 80601-2-84:2020(E)
— test for audible acoustic energy;
— tests for mechanical strength (via IEC 60601-1-12);
— tests for environmental conditions (via IEC 60601-1-12);
— tests for alarm conditions (via IEC 60601-1-8);
— tests for electromagnetic disturbances (via IEC 60601-1-2);
— inclusion of the usability engineering process (via IEC 60601-1-6);
— new symbols;

— requirements for ventilator for the emergency medical services environment as a

component of an ME system;
— tests for enclosure integrity (water ingress via IEC 60601-1-12);
— tests for cleaning and disinfection;

— determination of probability of component failure during the expected service life;

— delivered gas maximum enthalpy requirement;
— performance test and disclosure requirements for other inflation-types;
— enhanced inspired oxygen monitoring equipment requirements;
— consideration of input gas of Oxygen 93 %;
— use of the vocabulary and semantics of ISO 19223:2019;

— consideration of contamination of the breathing gas delivered to the patient from

the gas pathways.

A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the

ISO website.

Any feedback or questions on this document should be directed to the user’s national

standards body. A complete listing of these bodies can be found at
www.iso.org/members.html.
© ISO 2020 – All rights reserved vii
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ISO 80601-2-84:2020(E)
Introduction

This document is a major update of the requirements for a ventilator for the emergency

medical services environment. It includes harmonizing the requirements from ISO 10651-3,

which it replaces, with the third edition of IEC 60601-1 including its first amendment, the

fourth edition of IEC 60601-1-2, the second edition of IEC 60601-1-6 including its first

amendment, the third edition of IEC 60601-1-8 including its first amendment and the first

edition of IEC 60601-1-12.
In this document, the following print types are used:
— Requirements and definitions: roman type;

— Instructions, test specifications and terms defined in clause 3 of the general standard, in

this particular document or as noted: italic type;

— Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative

text of tables is also in a smaller type.
In referring to the structure of this document, the term

— “clause” means one of the five numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);

— “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are

all subclauses of Clause 201).

References to clauses within this document are preceded by the term “Clause” followed by

the clause number. References to subclauses within this particular document are by

number only.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if

any combination of the conditions is true.
For the purposes of this document, the auxiliary verb:
— “shall” means that conformance with a requirement or a test is mandatory for
conformance with this document;

— “should” means that conformance with a requirement or a test is recommended but is

not mandatory for conformance with this document;

— “may” is used to describe permission (e.g. a permissible way to achieve conformance

with a requirement or test);
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.

Annex C contains a guide to the marking and labelling requirements in this document.

Annex D contains a summary of the symbols referenced in this document.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table

title indicates that there is guidance or rationale related to that item in Annex AA.

viii © ISO 2020 – All rights reserved
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INTERNATIONAL STANDARD ISO 80601-2-84:2020(E)
Medical electrical equipment —
Part 2-84:
Particular requirements for basic safety and essential
performance of ventilators for the emergency medical services
environment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012.
201.1.1 * Scope
Replacement:

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 a 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:
© ISO 2020 – All rights reserved
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ISO 80601-2-84:2020(E)

⎯ 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

[3]
environment, which are given in ISO 80601-2-72 .

⎯ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‐

[4]
2‐13 .

⎯ ventilators or accessories intended for ventilatory support equipment (intended only to augment the

[5]

ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79 and

[6]
ISO 80601-2-80 .
[7]

⎯ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70 .

[8]
⎯ operator-powered resuscitators, which are given in ISO 10651‐4 .
[9]
⎯ gas-powered emergency resuscitators, which are given in ISO 10651‐5 .
⎯ continuous positive airway pressure (CPAP) ME equipment .
[11]
⎯ high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87 .
[10] [11]

⎯ high‐frequency oscillatory ventilators (HFOVs) , which are given in ISO 80601-2-87 .

NOTE 4 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-

modes.
⎯ cuirass or “iron‐lung” ventilators.
201.1.2 Object
Replacement:

The object of this particular document is to establish basic safety and essential performance

requirements for an EMS ventilator, as defined in 201.3.201, and its accessories.

Accessories are included because the combination of the EMS ventilator and the accessories needs

to have acceptable risk. Accessories can have a significant impact on the basic safety or essential

performance of an EMS ventilator.

NOTE 1 This document has been prepared to address the relevant essential principles of safety and performance of

ISO 16142-1:2016 as indicated in Annex CC.

NOTE 2 This document has been prepared to address the relevant general safety and performance requirements

of European regulation (EU) 2017/745.

ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.

© ISO 2020 – All rights reserved
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ISO 80601-2-84:2020(E)
201.1.3 Collateral standards
Amendment (add at the end of the subclause):

This document refers to those applicable collateral standards that are listed in Clause 2 of the

general standard and in 201.2 of this document.

IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8 and IEC 60601-1-12 apply as modified in Clauses

[12]

202, 206, 208 and 212 respectively. IEC 60601-1-3 and IEC 60601-1-11 do not apply. All other

published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard, including the collateral standards, as appropriate for the

particular ME equipment under consideration, and may add other basic safety or essential

performance requirements.

A requirement of a particular standard takes priority over IEC 60601-1:2005+AMD1:2012 or the

collateral standards.

For brevity, IEC 60601-1:2005+AMD1:2012 is referred to in this particular document as the

general standard. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular document corresponds to those of the

general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of

Clause 1 of the gene
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