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YY 0585.4-2024: Fluid lines for use with pressure infusion equipment and accessories for single use - Part 4: Check valves
YY 0585.4-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.040.20
CCS C 31
Replacing YY 0585.4-2009
Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 4.Check valves
(ISO 8536-12.2021, Infusion equipment for medical use - Part 12.Check
valves for single use, MOD)
ISSUED ON. JULY 8, 2024
IMPLEMENTED ON. JULY 20, 2027
Issued by. National Medical Products Administration
Table of Contents
Foreword... 4
Introduction... 6
1 Scope... 7
2 Normative references... 7
3 Terms and definitions... 8
4 Marks... 9
5 Materials... 9
6 Physical requirements... 9
6.1 Particle contamination... 9
6.2 Leakage... 9
6.3 Compatibility of YY/T 0916(all parts)... 9
6.4 Backflow pressure impedance... 9
6.5 Flow rate... 9
6.6 Blocking performance... 10
6.7 Opening pressure... 10
6.8 Protective cover... 10
7 Chemical requirements... 10
8 Biological requirements... 10
8.1 General... 10
8.2 Sterility... 10
8.3 Pyrogens... 10
9 Labeling... 11
9.1 General... 11
9.2 Single packaging... 11
9.3 Shelf or multi-unit packaging... 12
10 Packaging... 12
11 Disposal... 12
Appendix A (Normative) Physical Test... 13
A.1 General... 13
A.2 Particle contamination test... 13
A.3 Leakage test... 13
A.4 Backflow pressure impedance test... 14
A.5 Flow rate test... 14
A.6 Blocking performance test... 14
A.7 Determination of opening pressure... 16
References... 18
Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 4.Check valves
1 Scope
This document specifies the performance requirements for single-use check valves for
use with gravity infusion and/or pressure infusion sets.
This document applies to single-use check valves for use with gravity infusion and/or
pressure infusion sets. The basic requirements also apply to inline check valves.
2 Normative references
The provisions of the following documents constitute the essential clauses of this
document through normative references in this text. Among them, for referenced
documents with dates, only the versions corresponding to the dates are applicable to
this document; for referenced documents without dates, the latest versions (including
all amendments) are applicable to this document.
GB 8368 Infusion sets for single use - Gravity feed (GB 8368-2018, ISO 8536-
4.2010, MOD)
GB 15810 Sterile syringes for single use (GB 15810-2019, ISO 7886-1.2017,
MOD)
GB/T 16886.1 Biological evaluation of medical devices - Part 1.Evaluation and
testing within a risk management process (GB/T 16886.1-2022, ISO 10993-1.2018,
IDT)
YY/T 0466.1 Medical devices - Symbols to be used with information to be supplied
by the manufacturer - Part 1.General requirements (YY/T 0466.1-2023, ISO
15223-1.2021, MOD)
YY/T 0916(all parts) Small-bore connectors for liquids and gases in healthcare
applications [ISO 80369(all parts)]
NOTE. YY/T 0916.1-2021 Small-bore connectors for liquids and gases in healthcare applications
- Part 1.General requirements (ISO 80369-1.2018, IDT);
YY/T 0916.3-2022 Small-bore connectors for liquids and gases in healthcare applications
- Part 3.Connectors for enteral applications (ISO 80369-3.2016, IDT);
YY/T 0916.6-2022 Small-bore connectors for liquids and gases in healthcare applications
- Part 6.Connectors for neuraxial applications (ISO 80369-6.2016, IDT);
YY/T 0916.20-2019 Small-bore connectors for liquids and gases in healthcare applications
- Part 20.Common test methods (ISO 80369-20.2015, IDT).
ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical
use - Part 1.Extractables in aqueous autoclavates
ISO 8871-2 Elastomeric parts for parenterals and for devices for pharmaceutical
use - Part 2.Identification and characterization
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 blocking
Prevent the backflow through the check valve (3.2).
3.2 check valve
A valve that allows flow in one direction only.
3.3 inline check valve
A check valve (3.2) integrated with the infusion set.
3.4 flow rate
The speed at which the liquid passes through the open check valve (3.2) in its flow
direction.
3.5 backflow leak rate
The speed of liquid in the backflow direction flowing through the closed check valve
(3.2).
3.6 opening pressure
The pressure that opens the check valve (3.2) in the flow direction.
3.7 anti-siphon valve
A check valve (3.2) that requires a pressure greater than 2 kPa in the flow direction to
open.
6.6 Blocking performance
When tested according to A.6, the anti-backflow valve should be closed at a pressure
not greater than 2 kPa in the backflow direction.
6.7 Opening pressure
When tested according to A.7.1 and A.7.2, the check valve shall open at a pressure not
greater than 2 kPa.
NOTE. The 2 kPa opening pressure does not apply to "high pressure valves" such as anti-siphon valves
and imaging valves.
6.8 Protective cover
The check valve shall have a protective cover to protect it from contamination from the
surrounding environment and to avoid puncture and damage to the packaging. The
protective cover shall be secure but easy to remove.
7 Chemical requirements
GB 8368 applies.
8 Biological requirements
8.1 General
The biocompatibility of the check valve shall be evaluated according to GB/T 16886.1.
8.2 Sterility
GB 8368 applies.
8.3 Pyrogens
GB 8368 applies.
9 Labeling
9.1 General
The labeling shall comply with the provisions of 9.2 and 9.3.If graphic symbols are
used, they shall comply with the provisions of YY/T 0466.1.
NOTE. The ISO 7000 symbol 2725 can be used to indicate the presence of a substance of concern by
replacing "×××" with the abbreviation of the substance. If the substance is not present, a cross is drawn
on the symbol.
9.2 Single packaging
The single packaging shall be marked with at least the following information.
a) Name and address of the manufacturer;
b) Description of the contents;
c) The check valve is free of pyrogens, or the check valve is free of bacterial
endotoxins;
d) The graphic symbol given in YY/T 0466.1 is used to indicate that the check
valve is sterile;
e) Batch number, starting with "LOT" or using the graphic symbols given in
YY/T 0466.1;
f) The expiration date (year and month) expressed in corresponding text or by
the graphic symbol given in YY/T 0466.1;
g) The check valve is for one-time use only, or an equivalent textual description,
or a graphic symbol in accordance with YY/T 0466.1;
h) Instructions for use, including warnings, such as checking whether the
protective cover has fallen off (the instructions for use may also be in the form
of an insert);
i) The letter "P" for pressure, or the letter "G" for gravity, shall be large enough
to stand out from the surrounding text.
If the area of a single packaging is too small to provide all the information and/or
symbols, the information may be reduced to e) and f). In this case, the information
required by this paragraph shall be given on the label of the next larger shelf or multi-
Appendix A
(Normative)
Physical Test
A.1 General
All physical tests shall be carried out at a temperature of (23±2) °C unless the test
method specifies another temperature.
A.2 Particle contamination test
A.2.1 Methods
The test is carried out according to the method specified in GB 8368, but the eluent
preparation is carried out according to A.2.2.
A.2.2 Eluent preparation
Take 10 check valves in the test state and flush the inner cavity of each check valve
with 500 mL of distilled water along the liquid flow direction to obtain the eluent.
A.3 Leakage test
A.3.1 Before the test begins, condition the entire system at the test temperature.
A.3.2 Connect the inlet of the check valve to the air source, block the other outlets, and
apply an air pressure 50 kPa higher than the atmospheric pressure inside for 15 seconds.
Check the check valve for air leakage in water at (40±1) °C.
A.3.3 Fill the check valve with distilled water that has been degassed. Connect the outlet
of the check valve to a vacuum device. Apply a pressure of -20 kPa at (40±1) °C for 15
s to the inside of the valve and check whether there is air entering the check valve.
A.3.4 If used in conjunction with pressure equipment, additional tests shall be carried
out. Connect the inlet of the check valve to the air source, block other outlets, and apply
an air pressure 200 kPa higher than the atmospheric pressure or apply the maximum
working pressure of the supporting pressure equipment for 15 seconds. Inspect the
check valve for air leakage in water at (40±1) °C.
A.4 Backflow pressure impedance test
At (40±1) ℃, subject the check valve to a water pressure of 200 kPa from the backflow
direction for 15 min to check whether there is leakage through the check valve.
A.5 Flow rate test
Connect the check valve to an infusion set that meets the flow rate requirements of GB
8368 and test it according to the flow rate test in GB 8368.
A.6 Blocking performance test
A.6.1 The check valve shall be connected to the test system as shown in Figure A.1.
Connect the test specimen (check valve) to the device using appropriate connections
and/or components. The check valve shall be tested in the downstream position.
A.6.2 The entire system shall be filled with distilled water or sterile water, taking care
to avoid the generation of bubbles. Then perform the following test steps.
A.6.3 Adjust the test device according to "Position 1". Open all passages and remove
air from the system.
A.6.4 Adjust the test device according to "Position 2".
a) Adjust the water level in the outer barrel of the syringe to the starting scale V0;
b) Adjust the height difference between the water level in the outer barrel of the
syringe and the water level in the infusion container to h = (20±1) cm.
NOTE. The resulting static pressure difference is ΔP = 2 kPa.
A.6.5 Adjust the test device according to "Position 3".
a) Let the test device stand for 10 seconds ("standing time"; t0). The check valve
shall be closed at this time;
b) After t0, read the initial water level V1 in the outer barrel of the syringe;
c) Start test cycle t1.Test cycle t1 shall be no less than 15 minutes;
d) After the test cycle t1 is completed, read the final water level V2 in the outer
barrel of the syringe.
A.6.6 Calculation of backflow leak rate.