White Paper

Introduction to ISO/TR 21954:2018, Guidance on

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

1. Introduction ...................................................................................................................................................................... 3
2. Scope .................................................................................................................................................................................... 3
3. Structure and Content ................................................................................................................................................... 4
4. Comparison of Ventilator Product Standards ..................................................................................................... 5
5. References.......................................................................................................................................................................... 8
1. Introduction
ISO TR 21954 was developed by ISO TC 121/SC 3/JWG 12 – Joint Working Group on Home
Respiratory Equipment. It contains guidelines for the selection of appropriate ventilator equipment,
which comply with different product standards based on the following:

 the clinical condition of the patient;

 the environment where the ventilator is going to be used; and
 the person expected to operate the ventilator.

This white paper contains a condensed overview of the content and comparison information
extracted from selected annexes of ISO/TR 21954. It is aimed at clinicians, ventilator-selection
parties, respiratory therapists and other interested individuals. Users of this document are
encouraged to consider it as a starting point for ventilator selection and refer to ISO/TR 21954 for
more comprehensive guidance material.

2. Scope
ISO/TR 21954 considers all ventilation equipment types including those for critical care, homecare
(for dependent patients, ventilators for insufficiency and impairment), transport and emergency
medical services and emergency resuscitators. Sleep Apnoea devices are also included but are not
classified as ventilators. The ventilation equipment considered in ISO/TR 21954 is used in the
following environments:

 Professional Healthcare facilities

o Critical care
o Emergency care
o General care
o Outpatient clinic, step down/long term care
 Medical transport
o Road ambulance
o Air ambulance
 Home healthcare
o Domicile, dwelling
o Nursing home
o Mobile use including wheelchair, walking
o Personal use in transport including cars, buses, trains, ships, aircraft
The following considerations are also outlined in ISO/TR 21954:

 The state of the patient's health (fragility/acuity/stability);

 The patient's dependency on artificial ventilation;
 The consequence of loss of artificial ventilation;
 The required range of ventilation modes and corresponding patient monitoring;
 How often the patient needs assessment by a healthcare professional; and
 How often the patient needs respiratory-related care.

3. Structure and Content

ISO TR 21954 discusses the intended application of each type of ventilation equipment based upon
the:

a) clinical state of the patient;

b) use environment;
c) operator.

Additionally, there are the following seven annexes within ISO/TR 21954:

Annex Content
A* Explanation for ISO/TR 21954
Table outlining the important use environment characteristics (e.g.
B* temperature, humidity, electrical supply, mechanical stresses, interference from
other equipment)
Table mapping the standards referenced in ISO/TR 21954 to the intended use
C*
environments
Table mapping the intended patient, intended use environment and intended
D*
operator to the standards referenced in ISO/TR 21954
E* Table mapping the types of ventilation equipment with regard to patient acuity
Table comparing technical requirements of the standards referenced in
F*
ISO/TR 21954

*Section 4 of this White Paper contains a comparison table with information extracted from Annexes
D and F of ISO/TR 21954.

4. Comparison of Ventilator Product Standards

Table 1 contains information extracted from Annexes D and F of ISO/TR 21954. It compares the
intended PATIENT, intended USE ENVIRONMENT and intended OPERATOR for each ventilator product
standard, in addition to a selection of technical requirements within these standards.
 Table 1 — Comparison of appropriate ventilator product standard to the intended PATIENT, USE
ENVIRONMENT, OPERATOR and respiratory standards technical requirements

Emergency and Transport

ventilatory insufficiency

ISO 80601-2-79:2018 [5] d

ISO 80601-2-80:2018 [6] d
Home dependent patient
ISO 80601-2-72:2015 [7]

ISO 80601-2-70:2015 [8]

ventilatory impairment
Critical care ventilator

ISO 10651-3:1997 [11] b

ISO 80601-2-12:— [3] a

ISO 10651-6:2004 [9] c

Home non-dependent

Home non-dependent

Home non-dependent

[1]

ISO 10651-4:2002 [2]

O PERATOR powered
ISO 10651-5:2006
EN 794-3:1998

Sleep apnoea
Gas powered
resuscitator

resuscitator
ventilator

ventilator

ventilator
Intended PATIENT

Ventilatory VENTILATOR PATIENTS for

VENTILATOR- VENTILATOR- Moderate Minimal
support - whom
dependence DEPENDENT DEPENDENT dependence dependence All PATIENTS
DEPENDENT resuscitatio
as backup
n is
to primary
essential at
means of
scene of PATIENTS
Mild to ventilation,
Mild to emergency with
severe (e.g., No Mild to during
Mild to moderate Mild (e.g., where obstructive
Illness dependence intubation,
ARDS, moderate temporary sleep
acuity, severe (e.g., (e.g., mild to emergency
sepsis, life- (e.g., severe medical apnoea
fragility or ARDS, sepsis, severe moderate situations
instability threatening COPD, ALS, care can be
etc.) COPD, ALS, COPD, etc.) and for
bodily etc.) given prior
etc.) short term
injury, etc.) to use of
ventilation
EMS
VENTILATOR

Intended USE ENVIRONMENT

PROFESSION
Required Emergency Required as Required as Required as Required as
AL Medical
as dictated dictated by dictated by dictated by dictated by
HEALTHCARE Required Services Required
ENVIRONMEN
by patient patient patient patient patient
need environmen need need need Rescue or need
T
t emergency
HOME PROFESSIONA use
HEALTHCARE L
ENVIRONMEN
No Required Required Required Required Required Required
HEALTHCARE
T
FACILITIES

Intended OPERATOR
PROFESSION
AL healthcare healthcare healthcare healthcare healthcare healthcare healthcare
HEALTHCARE professional profession professiona professiona professiona professiona professiona
ENVIRONMEN operator al operator healthcare l operator l operator l operator minimally l operator l operator
T
professiona trained first
HOME l operator responders
HEALTHCARE Not trained lay trained lay trained lay trained lay trained lay trained lay
ENVIRONMEN applicable operator operator operator operator operator operator
T

Therapy Attributes
Intended
Invasive or Invasive or Invasive or Invasive or Invasive or
type of Invasive or Non-
non- No No non- non- non- non-
PATIENT non-invasive invasive
interface invasive invasive invasive invasive invasive
 Emergency and Transport

ventilatory insufficiency

ISO 80601-2-79:2018 [5] d

ISO 80601-2-80:2018 [6] d
Home dependent patient
ISO 80601-2-72:2015 [7]

ISO 80601-2-70:2015 [8]

ventilatory impairment
Critical care ventilator

ISO 10651-3:1997 [11] b

ISO 80601-2-12:— [3] a

ISO 10651-6:2004 [9] c

Home non-dependent

Home non-dependent

Home non-dependent

[1]

ISO 10651-4:2002 [2]

O PERATOR powered
ISO 10651-5:2006
EN 794-3:1998

Sleep apnoea
Gas powered
resuscitator

resuscitator
ventilator

ventilator

ventilator
Volume-
controlled Required Optional Optional No Optional Optional Required Optional No
breath
Pressure-
controlled Required Optional Optional No Optional Optional No No Required
breath

Safety Attributes
O2
MONITORING Required f Required f Optional No No No No No No
EQUIPMENT

Required f,
Required f, if
if expired
CO 2 expired
monitoring volume
volume No No No No No No No
equipment monitorin
monitoring
g not
not provided
provided

Required f, if Required f,
Expired > 50 ml if end-tidal
volume delivered CO2
Optional Optional Optional Optional No No No
MONITORING monitorin
Recommended
EQUIPMENT g not
, if < 50 ml
delivered provided

A IRWAY
PRESSURE
Required Required Required Required Required Required No No No
MONITORING
EQUIPMENT

45 hPa if
M AXIMUM body mass
LIMITED 60 hPa NC 60 hPa NC 30 hPa NC
105 hPa 90 hPa 60 hPa 90 hPa 60 hPa < 10 kg or
PRESSURE
PROTECTION
Required Required 100 hPa SFC Required Required Required 80 hPa SFC 60 hPa with 40 hPa SFC
DEVICE override
mechanism

Required if Required if
High
SFC SFC
pressure
Required Required Required delivered delivered No Required No No
ALARM
CONDITION pressure is pressure is
> 30 cm H20 > 40 cm H20
Low
pressure
No Required No No Required No No No No
ALARM
CONDITION
 Emergency and Transport

ventilatory insufficiency

ISO 80601-2-79:2018 [5] d

ISO 80601-2-80:2018 [6] d
Home dependent patient
ISO 80601-2-72:2015 [7]

ISO 80601-2-70:2015 [8]

ventilatory impairment
Critical care ventilator

ISO 10651-3:1997 [11] b

ISO 80601-2-12:— [3] a

ISO 10651-6:2004 [9] c

Home non-dependent

Home non-dependent

Home non-dependent

[1]

ISO 10651-4:2002 [2]

O PERATOR powered
ISO 10651-5:2006
EN 794-3:1998

Sleep apnoea
Gas powered
resuscitator

resuscitator
ventilator

ventilator

ventilator
S UPPLY Required
MAINS
for AC, DC,
failure Required Required No Required No No No No
ALARM
Battery or
CONDITION gas failure

Technical Attributes
Battery
backup Optional e Required Optional e Optional Required Optional No No No

Gas
pipeline
Required Optional Optional No Optional No Optional Optional No
Gas input
connection
T RANSIT -
OPERABLE
Optional Optional Required Optional Required Optional Required No Optional

No: Feature or attribute is not mentioned or requirement is specifically excluded.

Required: Feature is explicitly required by the standard.
Optional: Feature is optional - one way to implement a requirement.
Should: Feature is recommended by the standard.
a A new edition is being developed.
b Is being replaced by ISO 80601-2-84 [4].
c Is being replaced by ISO 80601-2-79 [5] and ISO 80601-2-80 [6].
d Is a partial replacement for ISO 10651-6 [9].
e Under consideration with next revision.
f Required to be equipped with or an external MONITORING EQUIPMENT is required prior to being put into service.
5. References
[1] ISO 10651-5:2006, Lung ventilators for medical use -- Particular requirements for basic
safety and essential performance -- Part 5: Gas-powered emergency resuscitators

[2] ISO 10651-4:2002, Lung ventilators -- Part 4: Particular requirements for operator
powered resuscitators

[3] ISO 80601-2-12:— , Medical electrical equipment -- Part 2-12: Particular requirements for
basic safety and essential performance of critical care ventilators

[4] ISO 80601-2-84:— , Medical electrical equipment -- Part 2-84: Particular requirements for
basic safety and essential performance of emergency and transport ventilators (future
replacement for ISO 10651-3)

[5] ISO 80601-2-79:2018, Medical electrical equipment -- Part 2-79: Particular requirements
for basic safety and essential performance of ventilatory support equipment for
ventilatory impairment

[6] ISO 80601-2-80:2018, Medical electrical equipment -- Part 2-80: Particular requirements
for basic safety and essential performance of ventilatory support equipment for
ventilatory insufficiency

[7] ISO 80601-2-72:2015, Medical electrical equipment -- Part 2-72: Particular requirements
for basic safety and essential performance of home healthcare environment ventilators for
ventilator-dependent patients

[8] ISO 80601-2-70:2015, Medical electrical equipment -- Part 2-70: Particular requirements
for basic safety and essential performance of sleep apnoea breathing therapy equipment

[9] ISO 10651-6:2004, Lung ventilators for medical use – Particular requirements for basic
safety and essential performance – Part 6: Home-care ventilatory support devices

[10] ISO/TR 21954:2018, Guidance on the selection of the appropriate types of ventilator
equipment based on the intended patient, use environment and operator

[11] ISO 10651-3:1997, Lung ventilators for medical use -- Part 3: Particular requirements for
emergency and transport ventilators