TEST REPORT

ISO 5367
Anaesthetic and respiratory equipment — Breathing sets and
connectors

Report reference number :

Date of issue :

Applicant name : nice Neotech Medical Systems Pvt. Ltd.

No.85, Krishna Industrial Estate, Mettukuppam,

Applicant address : Vanagaram, Chennai-600095,
Tamil Nadu, INDIA.
Test specification
: ISO 5367: 2023-07, Sixth edition
Standard

Test item description : Breathing Circuits

Model(s) : BC 510, BC 515, BC 520, BC 525, BC 530, BC 535,

BC 540, BC 545, BC 550, BC 555, BC 560, BC 565,
BC 570, BC 575, BC 590, BC 595 -- Infant/
Neonatal Bubble CPAP & Ventilator Breathing
Circuits

BC 610, BC 615, BC 620, BC 625, BC 635, BC 640,

BC 645, BC 650, BC 655, BC 660, BC 665, BC 670,
BC 675, BC 690, BC 695 -- Adult Ventilator
Breathing Circuits

BC 710, BC 715, BC 720, BC 725, BC 730, BC 735,

BC 740, BC 745, BC 750, BC 755, BC 760, BC 765,
BC 770, BC 775, BC 790, BC 795 -- Pediatric
Ventilator Breathing Circuits

BC 580, BC 585, BC 630 -- High flow therapy

Breathing Circuits

50-05-154, 50-05-150, 50-05-160 -- T-piece

Resuscitator Breathing Circuits

Trade mark :

Power ratings : NA (Non-electrical device)

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Testing laboratory : CVR Labs Pvt. Ltd.

Dignity Centre, Ii Floor, No.2/9, Abdul Razack

Test location & address :
Street, Saidapet, Chennai, Tamil Nadu, India

Date of receipt of test

: 06.05.2021
item

Date(s) of performance of
: 06.05.2021 to 10.05.2021
tests

Tested by
:
(name + signature)

Reviewed by
:
(name + signature)

Approved by
:
(name + signature)

Pictures of device with marking plate:

Front View Rear View

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Page 3 of 10
List of Attachments:

Annex I – Test setup photograph

Annex II – Calibration Certificates – Air Oxygen Blender Test Kit and Gas Flow Analyzer

Summary of Testing:

The product fulfils the requirements of ISO 5367: 2023, Sixth edition

Test case verdicts in this test report:

Test object does meet the standard

: Pass
requirement

Test case does not apply to the test object : N/A (Not Applicable)

Test object was not evaluated for the

: NE (Not Evaluated)
requirement

Test object does not meet the standard

: Fail
requirement

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General product information:

The Air Oxygen Blender is a precision proportioning device for mixing medical grade air
and oxygen to any concentration from 21% to 100% oxygen and delivering it to an air
source passes through a duckbill check valve which prevents reverse gas flows from
either source and oxygen at a pressure of 60 psi connected to two D.I.S.S fittings on the
bottom of the blender. Each fitting has a built-in 30 microns particulate filter.

The Model nice 5005 – Low Flow Air Oxygen Blender

The Model nice 5010 – High / Low Flow Air Oxygen Blender

Intended Use:

The nice 5005 Low flow Air/Oxygen Blender is perfect for NICU and Newborn Nursery
or for a flow of 30 lpm or less. Increased accuracy at even the lowest flow range. It
dispenses a continuous and precise blend of medical air and USP oxygen via outlet ports
to patients. The exact Fractional Concentration of Inspired Oxygen (FIO2) blend of gases
corresponds to the dialled in FIO2 setting indicated by the control knob.

The nice 5010 High/Low flow Air/Oxygen Blender is versatile dual range blender. Ideal
for equipment needing flows from 2 -120 lpm, yet also capable of increased accuracy
even at a low flow range. It dispenses a continuous and precise blend of medical air and
USP oxygen via outlet ports to infant, pediatric and adult patients. The exact Fractional
Concentration of Inspired Oxygen (FIO2) blend of gases corresponds to the dialled in
FIO2 setting indicated by the control knob.

General:

All models of the nice Neotech Air Oxygen Blender are a precision proportioning device
for mixing medical grade air and oxygen to any concentration and deliver to the required
source through 30 microns filter.

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Claus
Requirement – Test Result – Remark Verdict
e
4 General requirements
General
4.1 ISO 18190:2016, clause 4 requirements
shall be met
Recommended service life
Re-usable breathing sets and breathing
4.2 tubes shall confirm to the requirements of N/A
this standard throughout the recommended
service life in technical documentation
5 Materials
General
5.1 ISO 18190:2016, clause 5 requirements
shall be met
Biological safety testing
5.2 Breathing sets shall also be evaluated and Pass
tested in conformance with ISO 18562-1
6 Design requirements
General
6.1 ISO 18190:2016, clause 6 requirements
shall be met
6.2 Designated length
Designated length of the breathing tubes in
6.2.1 resting condition and in extended condition, Length to be provided
if intended to be used
Designated length of the breathing tubes Length to be provided
6.2.2 with patient end adaptor and any assembled
ends
Actual length shall be within ±10 % of the Length to be provided
6.2.3
designated length
6.3 Breathing tube ends
Breathing tubes shall have plain ends or
6.3.1 Assembled ends
assembled ends
Plain ends shall have axial lengths as
6.3.2 N/A
specified in Table 1
Plain ends shall not detach from their
6.3.3 respective cones when subjected to axial N/A
forces as specified in Table 1
Adaptor
The end of the adaptor that is not intended
6.3.4 for attachment to the breathing tube shall be N/A
a 22 mm or 15 mm or 11,5 mm socket
conforming to ISO 5356-1.
Assembled end
Adaptors shall not detach from the
breathing tube at a force of less than:
6.3.5 Test setup required
a) 45 N for 15 mm and 22 mm adaptors;
and
b) 30 N for 11,5 mm adaptors.

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 Adaptors for use in breathing sets or
breathing tubes for neonatal ventilation
using an 11,5 mm ISO 5356-1 compliant
socket conical connector shall not detach
from the breathing tube at a force of less
than 30 N
Patient connection ports
Patient connection ports shall be one of the
6.3.6 following: ???????
a) a coaxial 22 mm cone/15 mm socket;
b) a 15 mm socket;
6.4 Leakage
Leakage from breathing tubes shall not
6.4.1 exceed 10 ml/min at (60 ± 3) hPa [(60 ± 3) Test setup required
cmH2O].
Leakage from complete breathing sets shall
6.4.2 not exceed the leakage limit listed for the
designated patient category in Table 2
6.5 Resistance to flow
For breathing tubes supplied to be cut to
length, the manufacturer shall determine
and disclose [see 9.3.1 a)] the resistance to
6.5.1 N/A
flow per metre length of tubing at the flow
listed for the designated patient category in
Table 3.
The flow resistance shall not exceed the
limit in Table 3.
For breathing tubes supplied ready for use
or for each limb of a breathing set, the
manufacturer shall determine, mark, and
6.5.2 disclose [see 9.2 c) and 9.3.1 b)] the Test setup required
resistance to flow at the flow listed for the
designated patient category specified in
Table 4.
If the resistance exceeds the limit listed in
Table 4 for the designated patient category,
the risk shall be assessed in the risk
management file and, marked and disclosed
[see 9.2 c) and 9.3.1 b)].
The increase in flow resistance when
breathing tubes are suspended over a rigid
6.5.3
cylinder shall not exceed 150 % of the value
obtained when the tube is straight.
6.6 Compliance
For breathing tubes supplied to be cut to
length, the manufacturer shall determine
6.6.1 and disclose [see 9.3.1 d)] the compliance N/A
per metre of tubing at the pressure listed for
the designated patient category in Table 5.
The compliance per metre of the tubing

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 shall not exceed the limit in Table 5.
For breathing sets or breathing tubes
supplied ready for use, the manufacturer
shall determine mark, and disclose [see 9.2
6.6.2 Test setup required
e) and 9.3.1 e)] the total compliance at the
pressure listed for the designated patient
category in Table 5.
If the compliance exceeds the limit listed in
Table 6 for the designated patient category,
the risk shall be assessed in the risk
management file and, if required, marked
and disclosed [see 9.2 e) and 9.3.1 e)].
Axial strength of breathing tubes
6.7 Breathing tubes shall withstand an axial ???????
force of 45 N.
7 Requirements for breathing sets and breathing tubes supplied sterile
ISO 18190:2016, Clause 7 shall apply
8 Packaging
ISO 18190:2016, Clause 8 shall apply
9 Information supplied by the manufacturer
General
9.1
ISO 18190:2016, Clause 9 shall apply
Marking on the packaging
In addition to the marking requirements
9.2
specified in 9.1 the packaging shall be
marked with the following:
a) the designated length (see 6.2);
b) for breathing tubes supplied ready for
use, or for each limb of a breathing set, the
resistance to flow and the test flow in l/min
for the designated patient category in
accordance with 6.5.2 and, if applicable, the
risk assessment disclosure if the flow
resistance exceeds the limits listed in Table
3;
c) if other components (e.g. breathing filters,
HMEs) are attached to breathing sets or
breathing tubes, the total resistance to flow
and the test flow in l/min for the designated
patient category in accordance with 6.5.2
including these attached components;
d) for breathing tubes or breathing sets,
supplied ready for use, the total compliance
and the test pressure in hPa for the
designated patient category in accordance
with 6.6.2 and, if applicable, the risk
assessment disclosure if the compliance
exceeds the limits listed in Table 6;
e) if appropriate, the maximum pressure the

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 tubing and connectors can withstand at
ambient conditions expressed in Pascals.
9.3 Instructions for use
Resistance and compliance information
9.3.1
shall be supplied:
a) for breathing tubes supplied to be cut to
length, the resistance to flow per metre
length of tubing and the test flow in l/min for
the designated patient category in
accordance with 6.5.1;
b) for breathing tubes supplied ready for use
or for each limb of a breathing set, the
resistance to flow and the test flow in l/min
for the designated patient category in
accordance with 6.5.2 and, if applicable, the
risk assessment disclosure if the flow
resistance exceeds the limits listed in Table
3;
c) if other components (e.g. breathing filters,
HMEs) are attached to breathing tubes or
breathing sets, the total resistance to flow
and the test flow in l/min for the designated
patient category, in accordance with 6.5.2
including these attached components;
d) for breathing tubes supplied to be cut to
length, the compliance per metre of tubing
and test pressure for the designated patient
category in accordance with 6.6.1;
e) for breathing tubes and breathing sets,
supplied ready for use, the total compliance
and the test pressure in hPa for the
designated patient category in accordance
with 6.6.2 and, if applicable, the risk
assessment disclosure if the compliance
exceeds the limits listed in Table 5;
f) if other components (e.g. breathing filters,
HMEs) are attached to breathing tubes or
breathing sets, the total compliance and test
pressure for the designated patient
category, in accordance with 6.6.2 including
these attached components;
The manufacturer shall, when requested,
provide information on the recommended
maximum working temperature of the
9.3.2 breathing set or breathing tube when
attached to a heated humidifier, if breathing
set is intended to be used within active
humidification;
The manufacturer shall provide the
9.3.3 recommended maximum working pressure
of breathing sets or breathing tubes;

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 Unless breathing sets or breathing tubes
are intended and marked as being for single
use, the manufacturer shall provide details
of recommended methods of cleaning and
disinfection or sterilization, and the
9.3.4
maximum number or period of reuses, if
processing in accordance with the provided
instructions leads to a degree of
degradation that will limit the useful life of
the medical device.
Where such degradation is established, the
manufacturer shall provide an indication of
the number of reprocessing cycles that can
normally be tolerated, or some other
indication of the end of the medical device’s
ability to safely fulfil its intended use;
For coaxial and double-lumen breathing
sets, the manufacturer shall provide details
9.3.5
of recommended user test methods to verify
the integrity of the breathing set before use;

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