ISO TR 21954:2018

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

ISO TR 21954:2018 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.

General Information

• Status: Published
• Publication Date: 18-Jul-2018
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 30-Aug-2018
• Completion Date: 23-Jul-2018

Standards Content (Sample)

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
ISO/TR 21954:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2018 – All rights reserved

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/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

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/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 tab
...