80601-2-90 - Arg - Allocations

Compliance Standard Check List
Standard: ISO 80601-2-90

Date : 18-07-2022
# Clause
201.4.3.101 * Additional requirements for essential

performance
201.4.6.aa * ME equipment or ME system parts that

contact the patient
201.4.11.101.1.a.1 Overpressure requirement
201.4.11.101.1.a.2 Overpressure requirement
201.4.11.101.1.b Overpressure requirement

201.4.11.101.2.a Compatibility requirement
201.4.11.101.2.b.1 Compatibility requirement
201.4.11.101.2.b.2 Compatibility requirement
201.4.11.101.2.b.3.i Compatibility requirement
201.4.11.101.2.b.3.ii Compatibility requirement
201.4.11.101.2.b.3.iii Compatibility requirement
Respiratory high-flow therapy equipment

201.5.101.1.a.1 test conditions
201.5.101.1.a.2 Respiratory high-flow therapy equipment

test conditions
201.5.101.2 * Gas flowrate specifications

* Respiratory high-flow therapy equipment
201.5.101.3.a
testing errors
* Respiratory high-flow therapy equipment

201.5.101.3.b
testing errors
201.5.101.3.c * Respiratory high-flow therapy equipment

testing errors
201.5.101.3.d * Respiratory high-flow therapy equipment

testing errors
201.7.1.101 Information to be supplied by the

manufacturer
Information to be supplied by the

201.7.1.101.a
manufacturer

201.7.1.101.b manufacturer
201.7.1.101.c Information to be supplied by the

manufacturer
201.7.1.101.d manufacturer
201.7.2.4.101.a Additional requirements for accessories
201.7.2.4.101.b Additional requirements for accessories
201.7.2.4.101.b.1 Additional requirements for accessories
201.7.2.18.aa External gas source
201.7.2.18.bb External gas source
201.7.2.18.cc External gas source
201.7.2.18.dd External gas source
Additional requirements for marking on the

201.7.2.101.a.1 outside of ME equipment or ME equipment
parts

201.7.2.101.a.2 outside of ME equipment or ME equipment
parts

201.7.2.101.b.1 outside of ME equipment or ME equipment
parts
201.7.4.3 Units of measurement
201.7.9.2.1 General
201.7.9.2.1.101.b Additional general requirements
201.7.9.2.1.101.c Additional general requirements
201.7.9.2.2.101.a * Additional requirements for warnings and

safety notices
* Additional requirements for warnings and

201.7.9.2.2.101.b safety notices
201.7.9.2.2.101.c safety notices

201.7.9.2.2.101.d safety notices

201.7.9.2.2.101.e safety notices

201.7.9.2.2.101.f
safety notices
201.7.9.2.2.101.g * Additional requirements for warnings and

safety notices

201.7.9.2.2.101.h
safety notices
201.7.9.2.2.101.i safety notices

201.7.9.2.2.101.j
safety notices
201.7.9.2.2.101.k * Additional requirements for warnings and

safety notices

201.7.9.2.2.101.l safety notices

201.7.9.2.2.101.m
safety notices
201.7.9.2.2.101.n * Additional requirements for warnings and

safety notices

201.7.9.2.2.101.o
safety notices
201.7.9.2.2.101.p
safety notices

201.7.9.2.2.101.q safety notices

201.7.9.2.2.101.r
safety notices
* Additional requirements for start-up

201.7.9.2.8.101.b.1
procedure
201.7.9.2.8.101.b.2.i * Additional requirements for start-up

procedure
* Additional requirements for start-up

201.7.9.2.8.101.b.2.ii
procedure
Healthcare professional operator operating
201.7.9.2.9.101.2.a.1 instructions

201.7.9.2.9.101.2.a.2 instructions

201.7.9.2.9.101.2.a.3 instructions

201.7.9.2.9.101.2.a.4 instructions

201.7.9.2.9.101.2.a.5 instructions

201.7.9.2.9.101.2.b.1
instructions
201.7.9.2.9.101.2.b.2 Healthcare professional operator operating

instructions
201.7.9.2.9.101.2.c.1
instructions
201.7.9.2.9.101.2.c.2 Healthcare professional operator operating

instructions
201.7.9.2.12.aa.1 Cleaning, disinfection and sterilization
201.7.9.2.12.aa.2 Cleaning, disinfection and sterilization
201.7.9.2.13.101.a Additional requirements for maintenance
201.7.9.2.13.101.b Additional requirements for maintenance
Additional requirements for accessories,

201.7.9.2.14.101.a supplementary equipment, used material
201.7.9.2.14.101.b
supplementary equipment, used material

201.7.9.2.14.101.c
supplementary equipment, used material

201.7.9.2.14.101.d supplementary equipment, used material
201.7.9.3.1.101.a Additional general requirements
201.7.9.3.1.101.b Additional general requirements
201.7.9.3.1.101.c Additional general requirements
*Additional requirements for the technical

201.7.9.3.101.a description
*Additional requirements for the technical

201.7.9.3.101.b description
Additional requirements for audible

201.9.6.2.1.101.a acoustic energy
Additional requirements for audible

201.9.6.2.1.101.b
acoustic energy
201.9.6.2.1.101.c Additional requirements for audible
acoustic energy
201.11.1.2.2.aa * Applied parts not intended to supply heat

to a patient
* Applied parts not intended to supply heat

201.11.1.2.2.bb to a patient
201.11.1.2.2 * Applied parts not intended to supply heat
to a patient
201.11.2.2.1 Risk of fire in an oxygen rich environment
* Cleaning and disinfection of ME equipment

201.11.6.6.aa.1
or ME system

201.11.6.6.aa.2 or ME system

201.11.6.6.aa.3
or ME system
201.11.6.6.bb * Cleaning and disinfection of ME equipment

or ME system

201.11.6.6.cc
or ME system
201.11.6.6 or ME system
Biocompatibility of ME equipment and ME

201.11.7.aa system
Biocompatibility of ME equipment and ME

201.11.7.bb
system
201.11.8.101.1.b.1 Alarm conditions

201.11.8.101.1.c.1.i Alarm conditions
201.11.8.101.1.c.1.ii Alarm conditions
201.11.8.101.1.c.1.iii Alarm conditions
201.11.8.101.1.c.1.iv Alarm conditions
201.11.8.101.1.d.1.i Alarm conditions
201.11.8.101.1.d.1.ii Alarm conditions

201.11.8.101.1.d.4 Alarm conditions
201.11.8.101.1.d.5 Alarm conditions
201.12.1.cc.2 * Accuracy of controls and instruments
201.12.1.101.1.a Flowrate accuracy
201.12.1.101.1.b Flowrate accuracy

201.12.1.101.1.c Flowrate accuracy
201.12.1.101.1.d.1 Flowrate accuracy
201.12.1.101.1.d.2 Flowrate accuracy
201.12.1.101.1.e Flowrate accuracy
201.12.1.101.1 Flowrate accuracy
201.12.1.101.2.a Accuracy of delivered oxygen concentration
201.12.1.101.2.b.1 Accuracy of delivered oxygen concentration
201.12.1.101.2.b.2 Accuracy of delivered oxygen concentration
201.12.1.101.2.c Accuracy of delivered oxygen concentration

201.12.1.101.2.d.2 Accuracy of delivered oxygen concentration
201.12.1.101.2.e Accuracy of delivered oxygen concentration
201.12.1.101.2 Accuracy of delivered oxygen concentration
201.12.2.101.a Usability of ME equipment
201.12.2.101.b Usability of ME equipment
201.12.2.101.c.1 Usability of ME equipment
201.12.2.101.c.2 Usability of ME equipment
201.12.4.101.a.1 Oxygen monitor

201.12.4.101.a.2 Oxygen monitor
201.12.4.101.b Oxygen monitor
201.12.4.101.d Oxygen monitor
201.12.4.101.e.1 Oxygen monitor
* Maximum limited pressure protection

201.12.4.102.a.1 device
201.12.4.102.a.2 * Maximum limited pressure protection

device

201.12.4.102.b device
201.12.4.102.c
device
201.12.4.103.a Flowrate monitoring
201.12.4.103.b.1 Flowrate monitoring
201.12.4.103.c.1.iv Flowrate monitoring
201.12.4.103.c.2 Flowrate monitoring
201.12.4.104.a Obstruction alarm condition
201.12.4.104.b.1 Obstruction alarm condition
201.12.101.a.1 * Protection against accidental adjustments

201.12.101.b.1 * Protection against accidental adjustments
201.12.101.b.2 * Protection against accidental adjustments
201.12.101.c * Protection against accidental adjustments
201.13.2.101.a * Additional specific singlefault conditions
201.13.2.101.b * Additional specific singlefault conditions
201.13.2.101.c * Additional specific singlefault conditions
* Independence of delivery control function

201.13.2.102.a.1
and related risk control measures

201.13.2.102.a.2 and related risk control measures
201.13.2.102.b.1

201.13.2.102.b.2
* Failure of one gas supply to respiratory

201.13.2.103.a
high-flow therapy equipment

201.13.2.103.b

201.13.2.103.c.1
201.14.1.aa General
201.15.101 Mode of operation
201.15.102.b.1 Pre-use check
201.15.102.b.2 Pre-use check
201.15.103.a Delivered oxygen concentration

201.15.103.b Delivered oxygen concentration
Additional general requirements for ME

201.16.1.101.a systems
Additional general requirements for ME

201.16.1.101.b
systems
201.16.2 *Accompanying documents of an ME system
201.101.1.1.a * General
201.101.1.1.b * General
201.101.1.2.2 Patient-connection port
201.101.1.2.6 Flow-direction-sensitive components
201.101.2.a High-pressure oxygen inlet connector
201.101.2.b High-pressure oxygen inlet connector
201.101.3 Gas intake port
201.102.1 *General
201.102.2.a Labelling
201.102.2.b.1 Labelling
201.102.3.a Breathing sets
201.102.4.b * Humidification system
201.102.5 Breathing system filter (BSF)
201.102.6 Airway devices
201.103.a.1 * Indication of duration of operation
201.103.a.2 * Indication of duration of operation

201.103.b.1 * Indication of duration of operation
201.103.b.2 * Indication of duration of operation
201.104.1.a General
201.104.1.b General
201.104.2 * Connection to an electronic health record
201.104.3 * Connection to a distributed alarm system
201.104.4.a Connection for remote control
201.105 Power supply cords
201.105 Power supply cords

Respiratory high-flow therapy equipment
201.106 security
202.4.3.1 * Compliance criteria
202.8.1.101.b.1 * Additional general requirements

202.8.1.101.b.6 Additional general requirements
202.8.1.101.c Additional general requirements
206.101.a Primary operating functions
206.101.b Primary operating functions
206.101.c Primary operating functions
206.101.d Primary operating functions
206.101.e Primary operating functions
206.101.f Primary operating functions
206.101.g Primary operating functions
206.101.h Primary operating functions
206.101.i Primary operating functions
206.101.l Primary operating functions

206.101.m Primary operating functions
206.101.n Primary operating functions
206.101.o Primary operating functions
206.101.p Primary operating functions
206.101.q Primary operating functions
206.101.r Primary operating functions
206.101.s Primary operating functions
206.102.bb * Training
206.102.cc * Training
208.6.5.4.2.aa.1 Selection of default alarm preset

208.6.5.4.2.aa.2 Selection of default alarm preset
208.6.5.4.2.bb.1 Selection of default alarm preset
208.6.5.4.2.bb.2 Selection of default alarm preset
208.6.5.4.2.cc Selection of default alarm preset
208.6.12.2.a.1 * Operator alarm system logging

208.6.12.2.b.1 * Operator alarm system logging
208.6.12.2.b.2 * Operator alarm system logging
208.6.12.2.c.1 * Operator alarm system logging
208.6.12.2.d * Operator alarm system logging

208.6.12.2.e * Operator alarm system logging
208.6.12.2.f * Operator alarm system logging
208.6.12.2.g * Operator alarm system logging
208.6.12.2.h * Operator alarm system logging
208.6.12.2.k * Operator alarm system logging

Category
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Management
Management
Management
Testing
Testing
Management
Testing
Testing
Testing
Management
Technical
Technical
Technical
Technical
Technical
Management
Management
Management
Technical
Technical
Technical
Technical
Management
Management
Management
Technical
Risk Management
Risk Management
Risk Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Technical
Technical
Technical
Technical
Technical
Risk Management
Risk Management
Risk Management
Risk Management
Risk Management
Risk Management
Technical
Biocompatibility
Biocompatibility
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Testing
Management
Management
Management
Technical
Management
Risk Management
Testing
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Management
Management
Management
Management
Management
Management
Management
Management
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Testing
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Management
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Standard Statement
Additional essential performance requirements are found in the subclauses listed in Ta
aa) The breathing system or its parts or accessories that can come into contact with the
requirements for applied parts according to this subclause (i.e., 4.6 of IEC 60601-1:2005
a) If the respiratory high-flow therapy equipment is intended to be connected to a med

ISO 7396-1, then it
1) shall operate and meet the requirements of this document throughout its rated rang
2) shall not cause an unacceptable risk under the singlefault condition of 1 000 kPa.
If the respiratory high-flow therapy equipment has a maximum rated input pressure in
flow therapy equipment shall not cause an unacceptable risk under the singlefault cond
pressure.
If the respiratory high-flow therapy equipment is intended to be connected to a medica
ISO 7396-1, then
a) the rated range of input pressure shall cover the range specified in ISO 7396-1, and
b) under normal condition
1) the maximum 10 s average input flowrate required by the respiratory high-flow ther
exceed 60 1/min at a pressure of 280 kPa, measured at the gas intake port, and
b) under normal condition

2) the transient input flowrate shall not exceed 200 1/min averaged for 3 s. or
3) the accompanying documents shall disclose the following:

i) the maximum 10 s average input flowrate required by the respiratory high-flow thera
of 280 kPa, measured at the gas intake port;
ii) the maximum transient input flowrate averaged for 3 s required by the respiratory h
at a pressure of 280 kPa, measured at the gas intake port;

iii) a warning to the effect that this equipment is a high-flow device and should only be
designed using a diversity factor that allows for the indicated high flowrate at a specifie
avoid exceeding the pipeline design flowrate, thereby minimizing the risk that the equi
adjacent equipment.
a) For testing, the respiratory high-flow therapy equipment:

1)shall be connected to gas supplies as specified for normal use;
a) For testing, the respiratory high-flow therapy equipment:

2) except that industrial grade oxygen and air may be subsütuted for the equivalent me
otherwise stated.
In this document, requirements for the flowrate are expressed at standard temperatur
those associated with the breathing system, which are expressed under the conditions
Correct all test measurements to STPD or BTPS, as appropriate
a) For the purposes of this document, acceptance criteria for testing declared tolerance
(statistical uncertainty) procedure from IEC Guide 115:2021, 4.4.2.
b) Test equipment and methods shall be selected and controlled to ensure that the unc
confidence of 95%) is no more than 30% of the disclosed tolerance for the parameter b
c) For the purposes of this document, declared tolerances shall be adjusted by the mea
uncertainty.
d) The manufacturer shall disclose the measurement uncertainty of each disclosed tole
The information supplied by the manufacturer of respiratory high-flow therapy equipm

with ISO 20417:2021.
In applying ISO 20417:2021, the terms in this document and those in the general stand
a) The term "accompanying information" shall assume the same meaning as accompan
b) The term "medical device" shall assume the same meaning as ME equipment.
C) The term "user" shall assume the same meaning as operator.
d) The term "patient" shall include animals.
Accessories supplied separately shall fulfil the requirements of

a) 201.7.2.101; and
Accessories supplied separately shall fulfil the requirements of

b) be marked with an indication of any limitations or adverse effects of the accessory o
performance of the respiratory high-flow therapy equipment, if applicable.
1) If marking the accessory is not practicable, this information may be placed in the ins
aa) the gas name or chemical symbol in accordance with ISO 5359:2014+AMD1:2017;
bb) the rated range of gas pressure;
cc) for oxygen gas inputs, the rated range of oxygen concentration;
dd) gas-specific colour coding in accordance with ISO 32:1977 if colour coding is used
a) If applicable, marking of operator-detachable ME equipment parts or accessories sha

1) be clearly legible; and
a) If applicable, marking of operator-detachable ME equipment parts or accessories sha

2) include an arrow indicating the direction of the flow forflow-direction-sensitive comp
without the use of a tool;
b) If applicable, a clearly legible marking shall warn not to obstruct the gas intake port.
1) A symbol evaluated according to IEC 62366-1 as information for safety may be utilize
bb) except those associated with the breathing system which shall be expressed under
instructionsfor use as either:
1) STPD; or
2) BTPS
Amendment (add between the second and third bullet following the first paragraph):
- the intended position of the operator;
b) The manufacturer may choose in which instructions for use to place the information
otherwise indicated in this document based on risk management and usability consider
c) The healthcare professional operator instructions for use shall include the informatio
instructions for use.
The instructions for use shall include the following.

a) A warning statement to the effect that "WARNING: Do not cover the equipment or p
operation", including applicable examples
The instructionsfor use shall include the following.

b) A warning statement to the effect that "WARNING: Do not add any attachments or a
confravene the instructions for use of the equipment or accessory, as the equipment m
risk of degradation of health of the patient."
c) A warning statement to the effect that "WARNING: Do not use the equipment at an
altitude] or outside a temperature of [insert rated temperature range]. Using the equip
or above this altitude can compromise the equipment performance which consequentl
of the patient."

d) If applicable, a warning statement to the effect that "WARNING: Do not connect the
powered wheelchair unless the connection is listed in the instructions for use of the eq
compromise the equipment performance which consequently can result in degradation

e) A warning statement to the effect that "WARNING: To reduce the likelihood of disco
equipment performance use only accessories compatible with the equipment. Compati
instructions for use of either the equipment or the accessories"

f) A warning statement to the effect that "WARNING: The high-flow mode of this equip
breathing patient."

g) If applicable, a warning statement to the effect that "WARNING: The therapy supplie
affected by the gas added by the use of a pneumatic nebuliser."

h) A warning statement to the effect that "WARNING: It is the responsibility of the resp
oxygen source is compatible with the rated range of pressure, flowrate and oxygen con
and indicated in the instructions for use as this can affect the performance of the equip
consequently result in serious deterioration of health."
i) A warning statement to the effect that "WARNING: To prevent disconnection of the t
especially during ambulatory use, only use tubes with a retention force in conformance

j) A warning statement to the effect that "WARNING: Do not use sealed patient interfac
of suffocation or barotrauma".

k) A warning statement to the effect that "WARNING: There is a risk of fire associated w
therapy. Do not use the equipment or accessories near sparks or open flames."

l) A warning statement to the effect that "WARNING: Use only water-based lotions or s
and during oxygen therapy. Never use petroleum-based or oil-based lotions or salves to

m) A warning statement to the effect that "WARNING: Do not lubricate fittings, connec
equipment to avoid the risk of fire and burns."

n) A warning statement to the effect frat "WARNING: Use only spare parts recommend
function and to avoid the risk of fire and burns."

o) A warning statement to the effect that "WARNING: Oxygen makes it easier for a fire
nasal cannula or mask on bed coverings or chair cushions, if the equipment is turned on
the materials more flammable. Turn the equipment off when not in use to prevent oxy
p) A warning statementto the effect that "WARNING: Smoking during oxygen therapy is
burns or death. Do not allow smoking or open flames within the same room as the equ
accessories. If the patient intends to smoke, always turn the equipment off, remove th
equipment is located. If unable to leave the room, wait 10 minutes after you have turn

q) A warning statement to the effectthat"WARNING: Open flames during oxygen therap
in fire or death. Do not allow open flames within 2 m of the equipment or any oxygen-c

r) A warning statement to the effect that "WARNING: Ensure a sufficient intended leaka
the patient to allow the patient to exhale."
b) The instructionsfor use for the healthcare professional operator shall disclose a test
1) by which functions necessary for normal use can be tested to determine if they are o
2) which can determine whether or not the assembled breathing tubes and related acc
i) These test methods, or portions thereof, may be performed automatically by the resp
may require operator action
2) which can determine whether or not the assembled breathing tubes and related acc
ii) These test methods should be as automated as practicable.
a) The instructions for use intended for the healthcare professional operator shall inclu
of all therapy modes provided by the respiratory high-flow therapy equipment includin
1) the working principle of each of the respiratory high-flow therapy equipment's thera
2) the parameter settings;
3) the range of parameter settings;
4) any limitation of parameter settings; and
5) how to change breathing system configurations when necessary for a specific therap
b) The instructions for use intended for the healthcare professional operator shall inclu
following alarm conditions can be functionally tested:
1) flowrate, if equipped; and
b) The instructions for use intended for the healthcare professional operator shall inclu
following alarm conditions can be functionally tested:
2) obstruction
c) The instructions for use intended for the healthcare professional operator shall indic
flow therapy equipment
1) is intended for use with nebulized medications, and if so,
c) The instructions for use intended for the healthcare professional operator shall indic
flow therapy equipment
2) any constraints.
amendment: (add after normal use)

and single fault condition
amendment: (add after bulleted list)
aa) The instructions for use shall identify any portions of the gas pathways through the
that can become contaminated with body fluids or by microbial material conveyed by t
1) normal condition; and
amendment: (add after normal use)

and single fault condition
amendment: (add after bulleted list)
aa) The instructions for use shall identify any portions of the gas pathways through the
that can become contaminated with body fluids or by microbial material conveyed by t
2) single fault condition.
The instructionsfor use shall disclose:

a) a description of periodic safety inspections that should be performed by the operato
The instructionsfor use shall disclose:

b) if applicable, the care and maintenance procedures for the internal electrical power
recharging and replacement
The instructions for use of a respiratory high-flow therapy equipment shall identify:
a) at least one set of accessories; and
The instructions for use of a respiratory high-flow therapy equipment shall identify:
b) if applicable, the ME equipment necessary for the respiratory high-flow therapy equ
If applicable, the instructionsfor use shall disclose

c) any restrictions on the positioning of components within the breathing system.
If applicable, the instructionsfor use shall disclose

d) any adverse effect of any recommended accessory on the essential performance or b
therapy equipment.
The technical description shall disclose:

a) the interdependence of control functions;

b) a pneumatic diagram of the respiratory high-flow therapy equipment, including a dia
the breathing system either supplied or recommended in the instructions for use; and

c) a statement to the effect that prior to use the responsible organization needs to ens
and all of the parts and accessories with which the equipment is intended to be used.
a) The technical description shall include a description of a method for checking the pro
each of the alarm conditions specified in this document, if not performed automatically
b) The technical description shall disclose which checks are performed automatically
a) The A-weighted sound pressure level emitted by the respiratory high-flow therapy e
accordance with ISO 4871 : 1996 and ISO 3744:2010 using engineering method grade 2
b) The A-weighted sound power level shall be calculated according to 8.1 of ISO 3744:2
use.
Check conformance with thefollowing test:
c) Place the respiratory high-flow therapy equipment on the sound-reflecting plane and attach the
device rated as capable of delivering the maximum rated flowratefrom those indicated in the instru
d) Include the humidifier, provided with the respiratory high-flow therapy equipment or specified i
respiratory high-flow therapy equipment, in the test andfill to the least favourable level.
e) Acoustically isolate the breathing tube, airwaydeviceandgas leaving the breathing system bya su
noise caused by these does not interfere with the sound measurement ofthe respiratory high-flow
f) Set the respiratory high-flow therapy equipment to its maximum flowrate
g) Using a microphone of the sound level meter, conforming with the requirements of type 1 instru
the maximum time-weighted sound pressure level using frequency weighting A and the time weigh
10 positions in a hemisphere with a radiusfrom the geometric centre ofthe respiratory high-flow th
reflecting plane as specified in 8.1.1 of ISO 3744:2010. Average the values in conformance with 8.2.
h) Calculate the A-weighted sound pressure level averaged over the measurement surface accordin
i) Calculate the A-weighted sound power level according to 8.6 ofISO 3744:2010
j) Confirm that the criteria for background noise specified in 4.2 ofISO 3744:2010 arefulfilled.
k) Ensure that the measured sound pressure level is less than that disclosed in the instructionsfor u
In normal use and single fault conditions and over the rated flowrate range and at the m
the temperature of the gas delivered by the respiratory high-flow therapy equipment a
and without each humidifier specified for use in the instruction for use, when averaged
aa) 70◦c; and
In normal use and single fault conditions and over the rated flowrate range and at the m
the temperature of the gas delivered by the respiratory high-flow therapy equipment a
and without each humidifier specified for use in the instruction for use, when averaged
bb) an energy equivalent to 43◦c and 100 % relative humidity (a specific enthalpy not to
Table 201.102 contains examples of combinations of temperature and relative humidit
It is reasonably foreseeable that the ambient room air where respiratory high-flow the
concentration exceeding 25%
aa) Gas pathways through the respiratory high-flow therapy equipment and its accesso
become contaminated with body fluids or by microbial material conveyed by the expire
singlefault condition shall be designed to allow for:
1) cleaning and disinfection, or
2) cleaning and sterilization.
3) Dismantling or parts replacement may be performed.
bb) Respiratory high-flow therapy equipment enclosures shall be designed to allow for
reduce to acceptable levels the risk of infection of operators, bystanders, or the patien
CC) Processing instructions for the respiratory high-flow therapy equipment and its acc
1) conform with ISO 17664:2017; and
2) be disclosed in the instructionsfor use
Check conformance by inspection of the risk management file. When conformance wit
cleaning or the disinfection of the respiratory high-flow therapy equipment or its parts
for the number of cycles determined by the expected service life in accordance with th
for use, including any cooling or drying period. After these procedures, ensure that bas
maintained. Confirm that the manufacturer has evaluated the effects ofmultiple proces
cycles.
aa) The manufacturers of the respiratory high-flow therapy equipment, the breathing s
address in the risk management process the risks associated with the biocompatibility
stream arising from the gas pathway.
bb) The gas pathways shall be evaluated for biocompatibility according to ISO 18562-1:
b) If equipped with an internal electrical power source, respiratory high-flow therapy e

1) equipped with an automatic switchover to the internal electrical power source when
necessary to maintain normal operation.

2) capable of powering the respiratory high-flow therapy equipment for at least 30 min
power source.

3) provided with a means for determining the remaining capacity or operation time pro
source.

4) provided with a means to indicate that the respiratory high-flow therapy equipment
electrical power source.
c) The respiratory high-flow therapy equipment with an internal electrical power sourc
1) be equipped with an alarm system that:
i) detects an alarm condition of at least a low priority to indicate the switchover to the
ii) detects an alarm condition of at least a low priority to indicate there is at least 10 mi
internal electrical power source;
iii) detects an alarm condition of at least a medium priority to indicate there is at least
internal electrical power source;
iv) provides at least 5 min between the start of these two internal electrical power sou
d) If equipped with an internal electrical power source, the instructionsfor use shall dis
1) the operational time of the respiratory high-flow therapy equipment when powered
following conditions:
i) a fully charged power source; and
1) the operational time of the respiratory high-flow therapy equipment when powered
following conditions:
ii) the conditions of Table 201.104.
2) the behaviour of the respiratory high-flow therapy equipment after a switchover to
i) the internal electrical power source, and
2) the behaviour of the respiratory high-flow therapy equipment after a switchover to
ii) an alternative supply mains.
3) the behaviour of the respiratory high-flow therapy equipment during the recharging
i) the internal electrical power source, and
3) the behaviour of the respiratory high-flow therapy equipment during the recharging
ii) an alternative supply mains.
4) the minimum time between complete loss of internal electrical power source and
i) the start of the low priority impending internal electrical power source failure alarm
4) the minimum time between complete loss of internal electrical power source and
ii) the medium priority impending internal electrical power source failure alarm conditi
5) the maximum time required to fully charge the internal electrical power source.
cc) The controls and indicators related to the essential performance of respiratory high
legible under the conditions specified in IEC 60601-1:2005+AMD1:2012+ AMD2:2020, 7
2) with the intended position of the operator for the purpose evaluating the legibility o
respiratory high-flow therapy equipment.
a)With a breathing-therapy mode of continuous flow selected and the respiratory high
normal condition, the delivered flowrate accuracy, as determined for the test settings a
document, shall be disclosed in the instructionsfor use.
b) This disclosure shall include at least the maximum error of the delivered flowrate in
c) The errors may be reported separately for the following ranges of intended flowrate
1) Q > 30 1/min;
2) 30 1/min Q > 15 1/min; and
3) Q' 15 1/min.
d) The accuracy of the performance of the respiratory high-flow therapy equipment sh

1) determined for each breathing system and airway device configuration indicated in t
d) The accuracy of the performance of the respiratory high-flow therapy equipment sh

2) determined for the worst-case breathing system and airway device configurations in
e) If worst-case breathing system and airway device configurations are used, the ration
documented in the risk managementfile.
Check conformance by inspection of the risk managementfile for the rationale, if applic
flow rate errors.
For respiratory high-flow therapy equipment incorporating an oxygen concentration co

a) with the respiratmy high-flow therapy equipment operating in normal condition, the
accuracy, as determined for the test settings and conditions specified in this document
use.
b) this disclosure shall include:

1) the maximum error of the delivered oxygen concentration in relation to the set oxyg
b) this disclosure shall include:

2) the effects of the rated range of input oxygen concentration.
c) the errors may be reported separately for the following ranges of intended flowrate,
1) Q > 30 1/min;
2) 30 l/min > Q > 15 1/min; and
3) Q < 151/min
d) the accuracy of the performance of the respiratory high-flow therapy equipment sha
2) determined for the worst-case breathing system configurations indicated in the instr
e) if worst-case breathing system configurations are used, the rationale for their selecti
managementfile.
Check conformance by inspection of the risk managementfile for the rationale, if applic
oxygen concentration delivery.
a) Any flowrate setting change and its relation to any other flowrate settings shall be di
performed.
b) Any setting that affects the delivered oxygen concentration shall be displayed while
c) Respiratory high-flow therapy equipment intended for the home healthcare environ
organization:
1) with a means to allow the healthcare professional operator to have direct access to
201.106); and
c) Respiratory high-flow therapy equipment intended for the home healthcare environ
organization:
2) the healthcare professional operator with a means to restrict the lay operator from
settings (see 201.106).
a) For respiratory high-flow therapy equipment incorporating an oxygen concentration

therapy equipment:
1) shall be equipped with oxygen monitoring equipment for the measurement of the d
breathing tube or at the patient-connection port) that is integral to the respiratory high
a) For respiratory high-flow therapy equipment incorporating an oxygen concentration
therapy equipment:
2) the instructions for use shall contain a statement to the effect that the respiratory h
oxygen monitoring equipment that conforms with ISO 80601- 2-55:2018 for measurem
concentration (e.g. in the breathing tube or at the patient-connection port) before bein
b) Integrated oxygen monitoring equipment shall conform with the following subclause
1) 201.7.4.3;
2) 201.7.9.2.9.101 k);
3) 201.12.1.101;
4) 201.12.1.102;
5) 201.12.1.103; and
6) 208.6.1.2.
d) The oxygen monitoring equipment shall, in addition, be equipped with an alarm syst
alarm condition.
e) The high oxygen level alarm condition:

1) shall be at least medium priority; unless
a) A protection device shall be provided to prevent the airway pressure from exceeding
both:
1) normal condition; and
a) A protection device shall be provided to prevent the airway pressure from exceeding
both:
2) single fault condition.
b) The maximum limited pressure shall not exceed for more than 200 ms 60 hPa (60 cm
c) The protection device need not be a pressure relief valve but may be inherent in the
a) Respiratory high-flow therapy equipment should be equipped with monitoring equip
b) If equipped with flowrate monitoring equipment

1) the accuracy of the flowrate monitoring equipment shall be disclosed in the instructi

2) under steady-state conditions, the indicated delivered flowrate shall be accurate wit
instructionsfor use

3) the flowrate monitoring equipment may be equipped with an alarm system to indica
outside the flowrate alarm limits.
c) If the flowrate monitoring equipment is equipped with an alarm system,

1) the delivered flowrate alarm limits may be:
iv) respiratory high-flow therapy equipment-adjustable; or
c) If the flowrate monitoring equipment is equipped with an alarm system,

2) and if the alarm limits are adjustable by the respiratory high-flow therapy equipmen
algorithm that determines the alarm limit values shall be disclosed in the instructionsfo
a) The respiratory high-flow therapy equipment shall be equipped with monitoring equ
detects a technical alarm condition to indicate when the alarm limit for obstruction is r
b) The obstruction technical alarm condition:

1) shall be at least medium priority, unless
a) Means of protection against accidental adjustrnent of controls that can create a haza
including at least the following.
1) Turning off the flow shall require a very deliberate action.
2) Changing the oxygen level shall require a very deliberate action.
3) Turning the respiratory high-flow therapy equipment off.
b) These means may be accomplished by
1) utilizing hardware and software or a combination of both, or
b) These means may be accomplished by
2) two or more interactions with at least one dedicated confirmation action.
c) The usability of these means of protection shall be evaluated in the usability enginee
Respiratory high-flow therapy equipment shall be so constructed that the following sin
unacceptable risk:
a) misconnection of a breathing system control functional connection, monitoringfuncti
connection;
unacceptable risk:
b) a disruption of the gas delivery to the respiratory high-flow therapy equipment; and
unacceptable risk:
c) failure to install, removal of or failure of an operator-detachable breathing system fil
a) A singlefault condition shall not cause the simultaneous failure of:

1) the delivery-control function; and
a) A singlefault condition shall not cause the simultaneous failure of:

2) the corresponding protection device.
b) A singlefault condition shall not cause failure in such a way that a failure of:
1) the delivery-control function and the corresponding monitoring equipment is not de
b) A singlefault condition shall not cause failure in such a way that a failure of:
2) the delivery-control function and the corresponding alarm system is not detected.
a) Following the failure of one gas supply connected to a high-pressure inlet, the respir
automatically use the remaining gas supply, and otherwise maintain normal operation
concentration.
b) The respiratory high-flow therapy equipment shall be equipped with an alarm system
condition to indicate this gas supply failure.
c) The gas supply failure technical alarm condition:

1) shall be at least low priority; unless
The flowrate control PESS of the respiratory high-flow therapy equipment PEMS shall b
as defined in IEC 62304:2006+AMD1:2015 unless there is an independent risk control m
PESS.
Respiratory high-flow therapy equipment shall be suitable for continuous operation.
b) This test method

1) shall be performed automatically by the respiratory high-flow therapy equipment, b
b) This test method

2) may require operator action.
a) Respiratory high-flow therapy equipment operating in normal condition shall supply

oxygen concentration accuracy indicated in the instructionsfor use.
b) The disclosed oxygen concentration accuracy shall include the effects of
1) the range of the rated input oxygen concentration;
2) the available flow from the oxygen source; and
3) the delivered flowrate to the airway device.
Accessories connected to the breathing system shall be considered to

a) be part of the respiratory high-flow therapy equipment, or
Accessories connected to the breathing system shall be considered to

b) form an ME system with the respiratory high-flow therapy equipment
If applicable, a description of the use scenarios and ranges of flowrates over which elev
output port can lead to the failure of a respiratory gas humidifier to function to specific
a) Operator-detachable breathing system connections through which the main flow of

condition, excluding the patient-connection port shall be:
1) a 15 mm connector conforming with ISO 5356-1:2015;
2) a 22 mm connector conforming with ISO 5356-1:2015;
3) a 11,5 mm; connector conforming with ISO 5356-1:2015 for a neonatal or paediatric
4) a connector that does not engage with a conical connector conforming with ISO 535
engagement, disengagement and leakage requirements of that standard.
b) The breathing system, its parts or accessories shall not be equipped with connectors
the gas pathway with a connector conforming with ISO 80369- 7:2021.
The patient-connection port shall be one of the following:
a) a female 15 mm conical connector conforming with ISO 5356-1:2015;
b) a female 22 mm conical connector conforming with ISO 5356-1:2015;
c) a coaxial 15 mm/22 mm conical connector conforming with ISO 5356-1:2015; or
d) a connector that does not engage with a conical connector conforming with ISO 535
unless it conforms with the engagement, disengagement and leakage requirements of
standard.
If the respiratory high-flow therapy equipment incorporates any flow-direction-sensitiv

therapy equipment shall be so designed that incorrect connection does not present an
a) A high-pressure oxygen inlet connector of the respiratory high-flow therapy equipme

without the use of a tool, shall conform with:
1) ISO 80369-1:2018; or
2) female 9/16-18 UNF-2A-RH fitting; or
3) for connection to either a medical gas pipeline system or a pressure regulator, a hos
b) Respiratory high-flow therapy equipment with this inlet connector shall maintain ba
oxygen supply systems up to 600 kPa, in normal condition.
Respiratory high-flow therapy equipment that incorporates a gas intake port shall be d
cannot be blocked by a flat surface.
All breathing systems, their parts and accessories that can affect the basic safety or ess
conform with the requirements of this document, whether they are produced by the m
therapy equipment or by another entity ("third-party manufacturer").
The accompanying document provided with each breathing system, its parts or access
include at least one model or type reference of compatible respiratory high-flow therap
b) Statements shall be included in the accompanying document of each breathing syste
that:
1) breathing systems, their parts and accessories are validated for use with specific equ

that:
2) incompatible parts can result in degraded performance, and

that:
3) the responsible organization is accountable for the compatibility of the equipment a
to connect to the patient before use.
a) Breathing sets, other than heated breathing sets, intended for use in the breathing s
The respiratory high-flow therapy equipment:

b) the instructionsfor use shall contain a statement to the effect that the respiratory hi
humidifier that conforms with ISO 80601-2-74:2021 before being put into service.
Any BSF, either incorporated into the respiratory high-flow therapy equipment or recom
high-flow therapy equipment, shall conform with the relevant requirements of ISO 233
Airway devices recommended for use with the respiratory high-flow therapy equipmen
and ISO 18562-1:2017.
a) Respiratory high-flow therapy equipment should have means to indicate visually the
respiratory high-flow therapy equipment, either
1) automatically, or
a) Respiratory high-flow therapy equipment should have means to indicate visually the
respiratory high-flow therapy equipment, either
2) by operator action
b) The respiratory high-flow therapy equipment may also have means to indicate visua
1) the time since the last preventive maintenance, or
b) The respiratory high-flow therapy equipment may also have means to indicate visua
2) the time until the next recommended preventive maintenance.
Basic safety and essential performance shall be maintained if connections to the functi
therapy equipment
a) are disrupted; or
Basic safety and essential performance shall be maintained if connections to the functi
therapy equipment
b) if the equipment connected to those parts fails.
Respiratory high-flow therapy equipment should be equipped with a functional connec

the respiratory high-flow therapy equipment to an electronic health record
Respiratory high-flow therapy equipment should be equipped with a functional connec

distributed alarm system.
a) Respiratory High-flow therapy equipment may be equipped with a functional connec

the respiratory high-flow therapy equipment.
Any detachable power supply cord or detachable d.c. power cord of an elecffically pow
equipment shall be protected against accidental disconnection from the respiratory hig
of 30 N.
Check conformance by inspection and, for respiratory high-flow therapy equipment wh

detachable d.c. power cord, by thefollowing test.
a) Subject the detachable power supply cordforl min to an axial pull offorce of30 N.
b) During the test, the mains connector becoming disconnectedfrom the appliance inle
becoming disconnected from the d.c. input connector of the respiratory high-flow ther
Means of restricting access to changing or to the storage of changes shall be described
201.12.2.101 c) and 208.6.12.2].
the respiratory high-flow therapy equipment operated using the conditions and test co
The following degradations, if associated with basic safety or essential performance, sh

1) component failures;

2) changes in programmable parameters or settings;

3) reset to default settings;

1) component failures;

5) initiation of an unintended operation; and
6) during the testing, the error of the delivered flowrate shall not deviate by more than
c) The respiratory high-flow therapy equipmentmay exhibit temporary degradation ofp

performance indicated in the instructions for use during immunity testing) that does no
essential performance.
In the application of the requirements in 5.2 of IEC 62366-1:2015+AMD1:2020, the follo

operating functions:
a) observing monitored therapy parameters from the intended operator's position;
b) configuringthe breathing system including connection ofthe detachable parts ofthe b
flow therapy equipment;
c) connecting or disconnecting the patient-connection port of the breathing system to
d) selecting the appropriate size airway device.
e) attaching the airway device to the patient
f) processing the breathing system components;
g) starting the respiratory high-flow therapy equipment from power off including
1) performing the start-up procedure, and
2) checking the correct function of the system (patient interface, hose, leakage and setti
as the temperature and water-level of the humidifier);
h) connecting or disconnecting the oxygen source;
i) turning off the respiratory high-flow therapy equipment; and
l) performing a basic pre-use functional check of the respiratory high-flow therapy equ
m) setting and inadvertent change of settings of the operator-adjustable controls:
1) setting alarm limits;
2) inactivating alarm signals; and
3) setting therapy control parameters;
n) switching between power sources;
o) connecting and disconnecting the distributed alarm system;
p) testing power sources;
q) starting therapy from standby; and
r) activating standby
The following actions associated with therapy also shall be considered primary operatin
s) humidifying/conditioning gases delivered through the breathing system; and
In the application of the requirements in 5.6 and 5.8 of IEC 62366-1:2015+AMD1:2020,

for both:
bb) the healthcare professional operator; and
In the application of the requirements in 5.6 and 5.8 of IEC 62366-1:2015+AMD1:2020,

for both:
cc) the designee of the responsible organization (e.g. service personnel or processing p
aa) Whenever the respiratory high-flow therapy equipment is in healthcare professiona

professional operator indicates to the respiratory high-flow therapy equipment, prefer
patient has been connected to the respiratory high-flow therapy equipment, then:
1) the default respiratory high-flow therapy settings, including the default alarm preset
aa) Whenever the respiratory high-flow therapy equipment is in healthcare professiona
professional operator indicates to the respiratory high-flow therapy equipment, prefer
patient has been connected to the respiratory high-flow therapy equipment, then:
2) means shall be provided for the healthcare professional operator to select the respir
settings, including the alarm settings.
bb) Whenever the respiratmy high-flow therapy equipment is in lay operator mode and
high-flow therapy equipment on, then:
1) the respiratory high-flow therapy equipment shall assume the retained respiratory h
from previous use, or
bb) Whenever the respiratmy high-flow therapy equipment is in lay operator mode and
high-flow therapy equipment on, then:
2) means shall be provided for the operator to select respiratory high-flow therapy equ
settings.
cc) the manufacturer shall disclose in the instructions for use an estimate of the duratio
the respiratory high-flow therapy equipment is unable to restore the preset and the su
high-flow therapy equipment.
If an alarm system is provided with an operator alarm system log:

a) the alarm system shall log:
1) every alarm condition;
2) the date and time of beginning of the alarm condition;
3) the date and time of end of the alarm condition;
4) the associated alarm limits for that alarm condition, if operator-adjustable; and
5) where feasible, the data that caused the alarm condition;
b) the alarm system shall log for each alarm signal inactivation state:
1) its identity;
b) the alarm system shall log for each alarm signal inactivation state:
2) the date and time of the occurrence; and
c) the operator alarm system log shall include at least the following events:
1) initial state of the respiratory high-flow therapy equipment;
2) change of operator-adjustable alarm settings;
3) change of operator-adjustable therapy settings;
4) power supply source change;
5) access mode (lay operator or healthcare professional operator);
6) result of the last pre-use check;

d) the alarm system shall have a capacity of at least 1 000 events;
e) if a means is provided for the operator to indicate to the alarm system thata differen
event should be logged in the operator alarm system log;

f) the operatoralarm system log shall not lose the contents ofthe alarm system log duri
unless deleted by responsible organization action;

g) means may be provided for the operator to add explanatorynotes or comments to th
provided:
1) means should be provided to record the identity of the annotator and the date and ti

h) means shall not be provided for the operator to edit or delete entries in the operato
is admitted or a responsible organization alarm system log is provided;

k) the instructionsfor use shall indicate:
1) the means for the operator to access the operator alarm system log;
2) whether the log is maintained when the alarm system is powered down and whethe
captured in the log;
3) what happens to the contents of the log after the alarm system has experienced a to
internal electrical power source) for a finite duration;
4) the capacity of the log; and
5) what happens to the contents of the log as it reaches capacity
Summary
Amendment (add at end of4.6 prior to the compliance check):
NOTE 1 Internal pressure regulators can be needed to accommodate the

single fault condition of maximum input pressure, as well as the rated
range of input pressure.
NOTE 2 Under the singlefault condition of overpressure, it is desirable for
gas to continue to flow to the breathing system. Under this condition,
the flowrate from the respiratory high-flow therapy equipment is likely
to be outside of its specification.
NOTE Taking account of requirements for over-pressure and under-
pressure, this corresponds to a range 280 kPa to 600 kPa.
NOTE This is a change from previous respiratory documents, which
required tolerances to be adjusted by subffacting measurement
uncertainty from disclosed tolerance values to determine acceptance
criteria.
EXAMPLE If the manufacturer wishes to claim a tolerance for delivered

flowrate of ±(0,5 1/min +10 % of set o flowrate) then the uncertainty of
the measurement cannot exceed ±(0,16 1/min +3 % of set flowrate)
NOTE The manufacturer of the accessory can be the respiratory high-
flow therapy equipment manufacturer or another entity ("third-party
manufacturer" or durable medical equipment provider) and all these
entities are expected to ensure conformance with this requirement
Additional requirements are found in 201.102.
Amendment (add before the first dash prior to the compliance check):
EXAMPLE Colour coding to match the colour of the flexible hose or a gas
cylinder intended to be attached to the inlet connector.
NOTE In some countries, other colour coding is used.
EXAMPLE WARNING: Gas Intake - Do not obstruct

EXAMPLE 1 WARNING: Do not position next to a curtain that blocks the
flow of cooling air, thereby causing the equipment to overheat
EXAMPLE 2 WARNING: Do not block the gas intake port, thereby
interfering with patient therapy
EXAMPLE 3 WARNING: When using the equipment ina carrying case or
in-use bag, only use a carrying case or in-use bag that is listed in the
instructions for use, to prevent the equipment from overheating or
interfering with patient therapy.
NOTE Full face masks, ET tubes and helmets are examples of sealed
patient interfaces.
EXAMPLE A fault that causes loss of airflow
EXAMPLE Where such components are flow-direction-sensitive
components.
NOTE The least favourable airway device is typically the one with the
highest resistance to flow.
NOTE Additional requirements are found in IEC 60601-
1:2005+AMD1:2012+ AMD2:2020 11.6.7 and IEC 60601-1-11:2015, 8.1
and 8.2
amendment add additional requirement and replace the complience test
NOTE 1 ISO 14159110] provides guidance for the design of enclosures.

NOTE 2 For respiratory high-flow therapy equipment intended for home
healthcare environment, additional information regarding the order of
test is found in 211.10.1.1.
amendment add after text prior to the complience statement

NOTE 1 The worst-case breathing system configuration and airway
device can be different for each error or nominal flowrate.
Check standart for the test from f to o

NOTE 1 The worst-case breathing system configuration can be different
for each flowrate range
Check standart for the test from f to o
EXAMPLE Settings needing protection include flowrate and oxygen

concentration
EXAMPLE A speed limited centrifugal blower.
EXAMPLE 1 Flow-metering devices for connection to terminal units of
medical gas pipeline systems according to ISO 15002.
EXAMPLE 2 Integrated flowrate monitoring of critical care ventilators
EXAMPLE 3± [2 +(8 % of the set flowrate)] l/min
NOTE Reduced flowrates can be caused by increased resistance in the

breathing system.
EXAMPLE An alarm condition to warn of an obstructed inspiratory

breathing tube
amendment extend the last paragraph prior to the complience check
with
EXAMPLE Combination of the power-on self-test routines and operator

actions that functionally check the alarm signals.
NOTE Additional requirements are also found in 201.7.9.2.8.101.

EXAMPLE When a blower/turbine-based respiratory high-flow therapy
equipment is operating with settings that result in the delivered
breathing gas temperature exceeding 27 o c, which is beyond the rated
input temperature of the humidifier, cause the humidifier to reduce
humidification output below the lower limit allowed by ISO 80601-2-74.
EXAMPLE Agas intake port incorporating a protective cage, or with
multiple intake orifices arranged in a nonplanar geometry.
NOTE Airway devices used with respiratory high-flow therapy equipment
are non-sealing and typically include high-flow nasal cannula, tracheal
tube, tracheostomy tube with mask or face mask or helmet with large
exhaust ports.
EXAMPLE 1 Access controlled by a tool.
EXAMPLE 2 Access controlled by responsible organization password and
a technical description that is separate from the instructionsfor use.
EXAMPLE 3 Access controlled by individual operator password.
NOTE 1 Fora password to be considered secure, the owner of the
password needs to be capable of changing the password. EXAMPLE 4
Access confrolled by voice recognition.
EXAMPLE 5 Access controlled by fingerprints.
NOTE 2 Multiple means of restriction can be needed (e.g. one for the
responsible organization and one for each operator).
EXAMPLE 1 Delivered flowrate
EXAMPLE 2 Delivered oxygen concenffation
EXAMPLE Humidifier, nebulizer, water-frap, tubing, breathing system

filter, monitoring equipment.
NOTE For the purposes of this document the following functions are
considered primary operating functions even though they might not be
performed on the respiratory high-flow therapy equipment's operator
interface.
EXAMPLE 1 The low flowrate alarm condition is logged with start time
and date, end time and date, flowrate alarm limit and the flowrate value.
EXAMPLE The alarm system discards the oldest data when the log
becomes full.
Applicability Compliance Verfication Type
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A NC Testing
A NC Testing
A NC Compliance
A NC Compliance
A NC Compliance
A C Compliance
A C Compliance
A C Compliance
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC
A NC
A NC
A C
A C
A C
A C
A C
A C
A C
A C
A C
A NC
A C
A C
A C Testing
A C Testing
A NC Testing
A C Testing
A C Testing
A C Testing
A C Testing
A C Testing
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A C Compliance
A NC Compliance
A NC Testing
A NC Testing
A NC Compliance
A NC Compliance
A NC Compliance
A NC Testing
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Testing
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C
A NC
A NC
A C
A C
A C
A C
A C
A C
A C
A NC
A NC
A NC
A NC
A NC
A C
A C
A C Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A C Testing
A C Testing
A C Testing
A NC Compliance
A C Compliance
A NC Testing
A NC Testing
A NC Compliance
A NC Compliance
A NC Testing
A NC Testing
A NC Compliance
A NC Testing
A NC Testing
A C Testing
A C Compliance
A C
A C
A C Testing
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C Compliance
A C
A C Compliance
A C Compliance
A C Compliance
A NC
A NC
A NC
A NC
A C Testing
A C Testing
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Testing
A NC Compliance
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Compliance
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Compliance
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A NC Testing
A C Testing
A C Testing
A C Testing
A C Testing
A C Testing
A C Testing
A C Testing
A NC Testing
A C Testing
A NC Testing
A C Testing
A NC Compliance
Objective Evidence Required Action
Compliance with 60601-1
Functional testing and risk

management file

management file

management file
Compliance with ISO 7396
Require testing under these

conditions
Require testing under these

conditions
Manual
Manual
Manual
we mention using medical

gas in the IFU
we mention using medical

gas in the IFU
need to disclose in the IFU what

in STPD and whatin BTPS
Uncertainity calculation method
accompanying document
Label
Label
Label
BTPS condition is used
manual
Manual, risk management file

and usability engiineering file
Manual, risk management file

and usability engiineering file
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
manual
and
risk management file
manual
and
manual
and
manual
and
technical description
manual
manual
test report
test report
test report
test report
Risk management file

iso 18562
iso 18562
Manual
Manual
Manual
Manual
Manual
Manual
Manual
Manual
Manual
test report
Manual
Manual
Manual
Manual
Manual
Manual
Test Report
Manual
Manual
Manual
Manual
Manual
risk mangement file
Test Report
Manual
tests of iso 80601-2-55:2018
Functional testing
Functional testing
Functional testing
Functional testing
test report and maual
Functional testing
Functional testing
usability engineering file

test report and usability

engineering file
engineering file
engineering file

and
test report

and
test report

and
test report
Functional testing
Functional testing
Functional testing
Functional testing
test report
test report
test report
62304 checklist
manual and test report
manual and test report
manual
manual
test report
test report
accompanying documents
test reports
test of iso 5356-1:2015
test reports
test of iso 5356-1:2015
test reports
test report
test report
Fuctional testing
Label
accommpanying document
Third party supply the breathing

sets
manual
Third party supply the filters
Third party supply the masks

test report
test report
Test report
Technical Manual
EMC test report
EMC test report
EMC test report
EMC test report
EMC test report
EMC test report

EMC test report
EMC test report

Alarm testing
Alarm testing
Alarm testing
Alarm testing
Manual
Due Date Electrical Mechanical Software Risk
A A A
A A A A
A A
A A
A A A
A A
A A
A A
A A
A A
A A A
A
A
A A A
A
A A A
A A A
A A A
A
A A
A A
A A
A A
A A
A A A A
A A A
A A
A A A
A A
A A
A
A
A
A A
A A
A A
A A
A
A
A A
A A
A A A
A A A
A A A
A A A
A A A
A A A
A A A
A A A
A A
A A A
A
A A A
A A A
A A
A
A
A A A A
A A A A
A A
A
A A A A
A A A
A A A
A A A
A A A
A A
A A A A
A A A
A A A
A A A A
A A A A
A A A A
A A A A
A A A
A A A
A A A
A A A
A A A
A A A
A A A
A A A
A A A
A A A
A A A
A A
A A
A A A A
A A A A
A A A
A A A
A A A
A A A
A A A
A A
A A A A
A A A
A A A
A
A A A
A A
A A A
A
A
A A A
A A
A A A
A A
A A
A A
A A
A A
A A
A A A
A A A
A A
A A
A A
A A A
A A A
A A A
A
A
A
A A
A A
A A
A A
A A
A A A
A A
A A A
A A A
A A A
A A
A A
A A
A A
A A
A A
A A A
A A A
A A
A A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
follow up
Documentation Testing Predessisor
/Action Done
Status
A
A
A A
A A
A
A A
A A
A A
A A
A
A
A A
A A
A
A A
A
A
A
A
A
A
A A
A A
A A
A
A
A
A
A
A
A A
A A
A A
A A
A
A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A
A A
A A
A A
A A
A A
A A
A A
A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A
A
A A
A A
A A
A A
A A
A
A
A A
A A
A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A
A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
A A
remarks
NA Not applicaple Not Started Eng. Ayman Management
C Comply In-Progress Eng. Khaled Technical
NC Not comply Canceled Eng. Bakr Testing
CV Comply with validation Completed Eng. Mostafa Usability
4 Comply Eng. Islam Risk Management
5 Perfect Eng. Abdollah Biocompatibility
Eng. Zaghlool Title
Eng. Farouk
IT Team
Eng. Hafez
Dr. Hamdy
Eng.Aragawy
Eng. Waleed
Eng. A.A.megid
Eng. Kareem
Eng. M.Danash
Dr.A. Hassan
Dr. Khairy
Eng. Doaa
Compliance
Testing

80601-2-90 - Arg - Allocations

Uploaded by

Copyright:

Available Formats

80601-2-90 - Arg - Allocations

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

80601-2-90 - Arg - Allocations

Uploaded by

Copyright:

Available Formats

Compliance Standard Check List

Standard: ISO 80601-2-90

201.4.3.101 * Additional requirements for essential

201.4.6.aa * ME equipment or ME system parts that

201.4.11.101.1.a.1 Overpressure requirement

201.4.11.101.1.a.2 Overpressure requirement

201.4.11.101.1.b Overpressure requirement

201.4.11.101.2.b.1 Compatibility requirement

201.4.11.101.2.b.2 Compatibility requirement

201.4.11.101.2.b.3.i Compatibility requirement

201.4.11.101.2.b.3.ii Compatibility requirement

201.4.11.101.2.b.3.iii Compatibility requirement

Respiratory high-flow therapy equipment

201.5.101.1.a.2 Respiratory high-flow therapy equipment

201.5.101.2 * Gas flowrate specifications

* Respiratory high-flow therapy equipment

201.5.101.3.c * Respiratory high-flow therapy equipment

201.5.101.3.d * Respiratory high-flow therapy equipment

201.7.1.101 Information to be supplied by the

Information to be supplied by the

Information to be supplied by the

201.7.1.101.c Information to be supplied by the

201.7.2.4.101.a Additional requirements for accessories

201.7.2.4.101.b Additional requirements for accessories

201.7.2.4.101.b.1 Additional requirements for accessories

201.7.2.18.aa External gas source

201.7.2.18.bb External gas source

201.7.2.18.cc External gas source

201.7.2.18.dd External gas source

Additional requirements for marking on the

Additional requirements for marking on the

Additional requirements for marking on the

201.7.9.2.1.101.b Additional general requirements

201.7.9.2.1.101.c Additional general requirements

201.7.9.2.2.101.a * Additional requirements for warnings and

* Additional requirements for warnings and

* Additional requirements for warnings and

* Additional requirements for warnings and

* Additional requirements for warnings and

201.7.9.2.2.101.g * Additional requirements for warnings and

* Additional requirements for warnings and

* Additional requirements for warnings and

201.7.9.2.2.101.k * Additional requirements for warnings and

* Additional requirements for warnings and

* Additional requirements for warnings and

201.7.9.2.2.101.n * Additional requirements for warnings and

* Additional requirements for warnings and

* Additional requirements for warnings and

* Additional requirements for warnings and

* Additional requirements for start-up

201.7.9.2.8.101.b.2.i * Additional requirements for start-up

* Additional requirements for start-up

Healthcare professional operator operating

Healthcare professional operator operating

Healthcare professional operator operating

Healthcare professional operator operating

Healthcare professional operator operating

201.7.9.2.9.101.2.b.2 Healthcare professional operator operating

201.7.9.2.9.101.2.c.2 Healthcare professional operator operating