Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator

This document considers and identifies criteria about the intended patient, intended use environment, and intended operator across the spectrum of the types of ventilation-related equipment as listed below: — gas-powered resuscitator as specified in ISO 10651-5[1] [1]; — operator-powered resuscitator as specified in ISO 10651-4[2]; — ventilator for critical care as specified in ISO 80601-2-12[3] [2]; — ventilator for emergency medical services environment as specified in ISO 80601-2-84[4] [3], the future replacement for ISO 10651-3[5]; NOTE 1 ISO 80601‐2‐84 updates the content of ISO 10651‐3 and harmonizes it with IEC 60601-1:2005+AMD1:2012[6] and IEC 60601-1-12:2014[7]. — ventilator for ventilatory impairment in the home healthcare environment as specified in ISO 80601‑2‑79[8]; — ventilator for ventilatory insufficiency in the home healthcare environment as specified in ISO 80601‑2‑80[9]; — ventilator for ventilator-dependent patients in the home healthcare environment as specified in ISO 80601-2-72[10]; — sleep apnoea breathing therapy equipment as specified in ISO 80601-2-70[11]. NOTE 2 Sleep apnoea breathing therapy equipment is not considered to be an artificial ventilator. It is included in this discussion to highlight the differences, which indicate why sleep apnoea breathing therapy equipment is not considered a ventilator. This document is intended to provide guidance that can assist manufacturers, authorities having jurisdiction and users in the development, selection and application of different types of ventilatory equipment based on the intended patient, intended use environment and intended operator. [1] Numbers in square brackets refer to the Bibliography. [2] Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-12:2018. [3] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2018.

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Status
Published
Publication Date
18-Jul-2018
Current Stage
6060 - International Standard published
Start Date
24-May-2018
Completion Date
19-Jul-2018
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TECHNICAL ISO/TR
REPORT 21954
First edition
2018-07
Guidance on the selection of the
appropriate means of ventilation
based on the intended patient, use
environment, and operator
Reference number
ISO/TR 21954:2018(E)
ISO 2018
---------------------- Page: 1 ----------------------
ISO/TR 21954:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2018 – All rights reserved
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ISO/TR 21954:2018(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

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

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 * Applications of means of ventilation ........................................................................................................................................12

4.1 Critical care ventilator ............................................................................................................................................................12

4.1.1 Appropriate standard ...............................................................................................................................................12

4.1.2 Intended patient ........................................................................................................................................................12

4.1.3 Use environment .....................................................................................................................................................12

4.1.4 Intended operator ...................................................................................................................................................13

4.2 Ventilator for a ventilator-dependent patient in the home healthcare

environment .......................................................................................................................................................................................13

4.2.1 Appropriate standard ...............................................................................................................................................13

4.2.2 Intended patient ........................................................................................................................................................13

4.2.3 Use environment .....................................................................................................................................................14

4.2.4 Intended operator ...................................................................................................................................................14

4.3 Ventilator for the emergency medical services environment ......................................................14

4.3.1 Appropriate standard ...............................................................................................................................................14

4.3.2 Intended patient ........................................................................................................................................................14

4.3.3 Use environment .....................................................................................................................................................15

4.3.4 Intended operator ...................................................................................................................................................15

4.4 Home healthcare environment ventilator for a patient with ventilatory

insufficiency ......................................................................................................................................................................................15

4.4.1 Appropriate standard ...............................................................................................................................................15

4.4.2 Intended patient ........................................................................................................................................................15

4.4.3 Use environment .....................................................................................................................................................16

4.4.4 Intended operator ...................................................................................................................................................16

4.5 Home healthcare environment ventilator for a patient with ventilatory

impairment ...........................................................................................................................................................................................16

4.5.1 Appropriate standard ...............................................................................................................................................16

4.5.2 Intended patient ........................................................................................................................................................16

4.5.3 Use environment .....................................................................................................................................................17

4.5.4 Intended operator ...................................................................................................................................................17

4.6 Gas-powered emergency resuscitators ..........................................................................................................................17

4.6.1 Appropriate standard ...............................................................................................................................................17

4.6.2 Intended patient ...................................................................... ....................................................................................18

4.6.3 Use environment ......................................................................................................................................................18

4.6.4 Intended operator ....................................................................................................................................................18

4.7 Operator-powered resuscitators ......................................................................................................................................18

4.7.1 Appropriate standard ...............................................................................................................................................18

4.7.2 Intended patient ...................................................................... ....................................................................................18

4.7.3 Use environment .....................................................................................................................................................18

4.7.4 Intended operator ...................................................................................................................................................18

4.8 Sleep apnoea breathing therapy equipment ..................................................................................................18

4.8.1 Appropriate standard ...............................................................................................................................................18

4.8.2 Intended patient ........................................................................................................................................................18

4.8.3 Use environment ......................................................................................................................................................19

4.8.4 Intended operator ...................................................................................................................................................19

Annex A (informative) Rationale and guidance .....................................................................................................................................20

Annex B (informative) Comparison of the most important environmental characteristics ....................22

Annex C (informative) Applicable standard for the use environment ..........................................................................25

© ISO 2018 – All rights reserved iii
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ISO/TR 21954:2018(E)

Annex D (informative) Comparison of the appropriate product standard to the intended

patient, use environment and operator ..............................................................................................................................27

Annex E (informative) Comparison of the categories of patient acuity to the appropriate

product standard ..............................................................................................................................................................................................29

Annex F (informative) Comparison of respiratory standards technical requirements ................................32

Annex G (informative) Terminology — Alphabetized index of defined terms .......................................................37

Bibliography .............................................................................................................................................................................................................................39

iv © ISO 2018 – All rights reserved
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ISO/TR 21954:2018(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 on 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 the following

URL: www .iso .org/iso/foreword .html.

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

equipment, Subcommittee SC 3, Lung ventilators and related equipment, and IEC/TC 62, Electrical

equipment in medical practice, Subcommittee SC 62D, Electromedical equipment.
© ISO 2018 – All rights reserved v
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ISO/TR 21954:2018(E)
Introduction

This document uses common language to describe and clarify the intended patient, intended use

environment and intended operator that are applicable to the ventilation categories and sleep

apnoea breathing therapy equipment for which there are ISO standards. There is confusion in the

marketplace as to which standard (and therefore the related equipment) is appropriate for which type

of patient. This document is intended to help answer that question. This document does not categorize

patients by size, weight or age. Throughout this document, the following considerations are delineated:

— the state of the patient's health (fragility/acuity/stability);
— the patient's dependency on artificial ventilation;
— the consequence of loss of ventilation;
— the required range of ventilation modes and corresponding patient monitoring;
— how often the patient needs assessing by a healthcare professional;
— how often the patient needs respiratory-related care.
Additionally, there are seven annexes.
— Annex A contains the rationale for this document.

— Annex B contains a table that compares some of the most important environmental characteristics

and requirements of the home healthcare environment, professional healthcare facility

environment, and emergency medical services environment.

— Annex C contains a table that highlights where the ventilators that are covered by each of the

standards are intended to be utilized.

— Annex D contains a table that compares the intended operator, intended patient and intended use

environment for each of the standards discussed in this document.

— Annex E contains a table that numerically compares the types of ventilation-related equipment with

regard to intended patient care.

— Annex F contains a comparison of selected technical requirements between various international

standards for ventilation-related devices.
— Annex G contains an alphabetized list of defined terms used in this document.

Terms used throughout this document that have been defined in Clause 3 appear in small capitals.

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 A.
vi © ISO 2018 – All rights reserved
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TECHNICAL REPORT ISO/TR 21954:2018(E)
Guidance on the selection of the appropriate means
of ventilation based on the intended patient, use
environment, and operator
1 * Scope

This document considers and identifies criteria about the intended patient, intended use environment,

and intended operator across the spectrum of the types of ventilation-related equipment as listed below:

[1]
— gas-powered resuscitator as specified in ISO 10651-5 ;
[2]
— operator-powered resuscitator as specified in ISO 10651-4 ;
[3]
— ventilator for critical care as specified in ISO 80601-2-12 ;
[4]

— ventilator for emergency medical services environment as specified in ISO 80601-2-84 ,

[5]
the future replacement for ISO 10651-3 ;

NOTE 1 ISO 80601-2-84 updates the content of ISO 10651-3 and harmonizes it with IEC 60601-

[6] [7]
1:20 05+A M D1: 2012 and IEC 60601-1-12:2014 .

— ventilator for ventilatory impairment in the home healthcare environment as specified in

[8]
ISO 80601-2-79 ;

— ventilator for ventilatory insufficiency in the home healthcare environment as specified

[9]
in ISO 80601-2-80 ;

— ventilator for ventilator-dependent patients in the home healthcare environment as

[10]
specified in ISO 80601-2-72 ;
[11]
— sleep apnoea breathing therapy equipment as specified in ISO 80601-2-70 .

NOTE 2 Sleep apnoea breathing therapy equipment is not considered to be an artificial ventilator.

It is included in this discussion to highlight the differences, which indicate why sleep apnoea breathing

therapy equipment is not considered a ventilator.

This document is intended to provide guidance that can assist manufacturers, authorities having

jurisdiction and users in the development, selection and application of different types of ventilatory

equipment based on the intended patient, intended use environment and intended operator.

2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
1) Numbers in square brackets refer to the Bibliography.

2) Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-12:2018.

3) Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2018.
© ISO 2018 – All rights reserved 1
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ISO/TR 21954:2018(E)

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp

NOTE For convenience, an alphabetical index of all defined terms used in this document is given in Annex G.

3.1
accessory
additional part for use with equipment in order to
— achieve the intended use,
— adapt it to some special use,
— facilitate its use,
— enhance its performance, or
— enable its functions to be integrated with those of other equipment
[SOURCE: IEC 60601-1:2005, 3.3]
3.2
accompanying document

document accompanying me equipment, an me system, equipment or an accessory and containing

information for the responsible organization or operator, particularly regarding basic safety and

essential performance
[SOURCE: IEC 60601-1:2005, 3.4]
3.3
airway pressure
pressure at the patient-connection port
[SOURCE: ISO 80601-2-12:—, 201.3.201]
3.4
alarm condition

state of the alarm system when it has determined that a potential or actual hazardous situation

exists for which operator awareness or response is required

Note 1 to entry: An alarm condition can be invalid, i.e. a false positive alarm condition.

Note 2 to entry: An alarm condition can be missed, i.e. a false negative alarm condition.

[SOURCE: IEC 60601-1-8:2006+AMD1: 2012, 3.1]
3.5
alarm signal

type of signal generated by the alarm system to indicate the presence (or occurrence) of an alarm

condition
[SOURCE: IEC 60601-1-8:2006, 3.9]
3.6
alarm system

parts of me equipment or a me system that detect alarm conditions and, as appropriate, generate

alarm signals
[SOURCE: IEC 60601-1-8:2006, 3.11]
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ISO/TR 21954:2018(E)
3.7
applied part

part of me equipment that, in normal use, necessarily comes into physical contact with the patient

for me equipment or an me system to perform its function
[SOURCE: IEC 60601-1:2005, 3.8, modified — deleted notes.]
3.8
basic safety

freedom from unacceptable risk directly caused by physical hazards when me equipment is used

under normal condition and single fault condition
[SOURCE: IEC 60601-1:2005, 3.10]
3.9
body-worn

transportable equipment whose intended use includes operation while being worn by a patient or

attached to a patient’s clothing
Note 1 to entry: Transportable equipment can be both body-worn and hand-held.
[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.144]
3.10
class i

electrical equipment in which protection against electric shock does not rely on basic insulation only,

but which includes an additional safety precaution in that means are provided for accessible parts of

metal or internal parts of metal to be protectively earthed
[SOURCE: IEC 60601-1:2005, 3.13, modified — deleted note.]
3.11
class ii

electrical equipment in which protection against electric shock does not rely on basic insulation only,

but in which additional safety precautions such as double insulation or reinforced insulation are

provided, there being no provision for protective earthing or reliance upon installation conditions

[SOURCE: IEC 60601-1:2005, 3.14, modified — deleted note.]
3.12
continuous positive airway pressure
cpap
therapeutic continuous positive airway pressure during the respiratory cycle
[SOURCE: ISO 80601-2-70:2015, 201.3.205]
3.13
distributed alarm system
alarm system that involves more than one item of equipment of a me system

Note 1 to entry: The parts of a distributed alarm system can be widely separated in distance.

[SOURCE: IEC 60601-1-8:2006, 3.17]
3.14
ems ventilator
ventilator for emergency medical services environment
ventilator intended for use in the ems environment
[SOURCE: ISO 80601-2-84:—, 201.3.201]
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ISO/TR 21954:2018(E)
3.15
* ems environment
emergency medical services environment

actual conditions and settings, in which operators interact with the me equipment or me system,

in and around the scene of an emergency outside of a professional healthcare facility where a

patient can be given medical care, basic or advanced life support as well as during professional

transport to a professional healthcare facility or between professional healthcare facilities

[SOURCE: IEC 60601-1-12:2014, 3.1, modified — deleted notes.]
3.16
essential performance

performance of a clinical function, other than that related to basic safety, where loss or degradation

beyond the limits specified by the manufacturer results in an unacceptable risk

Note 1 to entry: Essential performance is most easily understood by considering whether its absence or

degradation would result in an unacceptable risk.
[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.27]
3.17
fixed

fastened or otherwise secured at a specific location either permanently or so that it can only be

detached by means of a tool
EXAMPLE 1 Permanently affixed by welding, etc.

EXAMPLE 2 Affixed by means of fasteners (screws, nuts, etc.) making removal/opening impossible without

using a tool.
[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.30, modified — deleted note.]
3.18
functional connection

connection, electrical or otherwise, including those intended to transfer signals, data, power or

substances

Note 1 to entry: Connection to a fixed supply mains socket-outlet, whether single or multiple, is not considered

to result in a functional connection.
[SOURCE: IEC 60601-1:2005, 3.33]
3.19
hand-held

equipment that, once installed and placed into service, is intended to be supported by the hand

Note 1 to entry: Equipment can refer to accessories or equipment parts.
[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.37, modified — deleted note 2.]
3.20
harm

physical injury or damage to the health of people or animals, or damage to property or the environment

[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.38]
3.21
hazard
potential source of harm
[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.39]
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ISO/TR 21954:2018(E)
3.22
hazardous situation

circumstance in which people, property, or the environment are exposed to one or more hazard(s)

[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.40]
3.23
healthcare professional

individual with relevant specialized training, knowledge and skills who provides preventive, curative,

promotional or rehabilitative health care services in a systematic way to people, families or communities

[SOURCE: ISO 60601-2-12:—, 201.3.210]
3.24
* home healthcare environment

dwelling place in which a patient lives or other places where patients are present, excluding

professional healthcare facility environments where operators with medical training are

continually available when patients are present

EXAMPLE In a car, bus, train, boat or plane, in a wheelchair or walking outdoors.

Note 1 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical

centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms,

multiple treatment facilities and emergency medical services.

Note 2 to entry: For the purpose of this document, nursing homes are considered home healthcare

environments.

Note 3 to entry: Other places where a patient is present include the outdoor environment, while working and in

vehicles.
[SOURCE: IEC 60601-1-11:2015, 3.1]
3.25
intended use

use for which a product, process or service is intended according to the specifications, instructions and

information provided by the manufacturer

Note 1 to entry: Intended use should not be confused with normal use. While both include the concept of use as

intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates

not only the medical purpose, but maintenance, transport, etc. as well.
[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.44]
3.26
lay, adj.
non-professional or professional without relevant specialized training
EXAMPLE Lay operator, lay responsible organization.
[SOURCE: IEC 60601-1-11:2015, 3.2]
3.27
manufacturer

natural or legal person with responsibility for the design, manufacture, packaging, or labelling of

me equipment, assembling an me system, or adapting me equipment or an me system, regardless of

whether these operations are performed by that person or on that person's behalf by a third party

[15]

Note 1 to entry: ISO 13485 defines “labelling” as written, printed or graphic matter

— affixed to a medical device or any of its containers or wrappers, or
— accompanying a medical device,
© ISO 2018 – All rights reserved 5
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ISO/TR 21954:2018(E)

related to identification, technical description, and use of the medical device, but excluding shipping documents.

In this document, that material is described as markings and accompanying documents.

Note 2 to entry: “Adapting” includes making substantial modifications to me equipment or an me system

already in use.

Note 3 to entry: In some jurisdictions, the responsible organization can be considered a manufacturer when

involved in the activities described.
Note 4 to entry: Adapted from ISO 14971:2007, 2.8.

[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.55, modified — replaced 'standard' by 'document'.]

3.28
maximum limited pressure
LIM max
highest airway pressure during normal use or under single fault condition
[SOURCE: ISO 80601-2-12:—, 201.3.214]
3.29
me equipment
medical electrical equipment

electrical equipment having an applied part or transferring energy to or from the patient or detecting

such energy transfer to or from the patient and which is:
a) provided with not more than one connection to a particular supply mains;
b) intended by its manufacturer to be used
1) in the diagnosis, treatment, or monitoring of a patient, or
2) for compensation or alleviation of disease, injury or disability

Note 1 to entry: Me equipment includes those accessories as defined by the manufacturer that are necessary

to enable the normal use of the me equipment.

Note 2 to entry: Not all electrical equipment used in medical practice falls within this definition (e.g. some in

vitro diagnostic equipment).

Note 3 to entry: The implantable parts of active implantable medical devices can fall within this definition, but

they are excluded from the scope of this document by appropriate wording in Clause 1.

Note 4 to entry: This document uses the term “electrical equipment” to mean me equipment or other electrical

equipment.

[SOURCE: IEC 60601-1:2005, 3.63, modified — deleted note 5 and replaced 'standard' by 'document'.]

3.30
me system
medical electrical system

combination, as specified by its manufacturer, of items of equipment, at least one of which is

me equipment to be inter-connected by functional connection or by use of a multiple socket-outlet

Note 1 to entry: Equipment, when mentioned in this document, should be taken to include me equipment.

[SOURCE: IEC 60601-1:2005, 3.64, modified — replaced 'standard' by 'document'.]
3.31
mobile

transportable equipment that, once installed and placed into service, is intended to be moved from

one location to another while supported by its own wheels or equivalent means
[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.65, modified — deleted note.]
6 © ISO 2018 – All rights reserved
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ISO/TR 21954:2018(E)
3.32
monitoring equipment
me equipment or part that continuously or continually measures and in
...

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