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| Standard ID | YY 0585.4-2024 (YY0585.4-2024) | | Description (Translated English) | Fluid lines for use with pressure infusion equipment and accessories for single use - Part 4: Check valves | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 14,183 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2027-07-20 | | Older Standard (superseded by this standard) | YY 0585.4-2009 | | Administrative Organization | National Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC 106) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Standard ID | YY 0585.4-2009 (YY0585.4-2009) | | Description (Translated English) | Fluid lines for use with pressure infusion equipment and accessories for single use - Part 4: Check valves | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 9,978 | | Date of Issue | 2009-12-30 | | Date of Implementation | 2011-06-01 | | Quoted Standard | GB/T 1962.2; GB 8368; GB/T 16886.1; YY 0466; ISO 8871-1; ISO 8871-2 | | Adopted Standard | ISO 8536-12-2007, MOD | | Drafting Organization | Shandong Province Quality Inspection Center of Medical Devices | | Administrative Organization | National Technical Committee of Standardization for medical infusion | | Summary | This standard applies to single use, gravity infusion and/or pressure with a sterile infusion fluid type backflow preventer. |
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.
......
YY 0585.4-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Fluid lines for use with pressure infusion
equipment and accessories for single use -
Part 4. Check valves
(ISO 8536-12.2007 Infusion equipment for medical use
Part 12. Check valves, MOD)
ISSUED ON. DECEMBER 27, 2009
IMPLEMENTED ON. JUNE 01, 2009
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Marks ... 5
5 Materials ... 5
6 Physical requirements ... 5
7 Chemical requirements ... 6
8 Biological requirements ... 6
9 Packaging... 7
10 Labels ... 7
Annex A ... 9
Annex NA ... 13
Foreword
The Part modified and adopted ISO 8536 12.2007 “Infusion equipment for medical use
- Part 12. Check valves”.
The general title of YY 0585 is “Fluid lines for use with pressure infusion equipment
and accessories for single use”, including the following parts.
Part 1. Fluid lines;
Part 2. Accessories;
Part 3. Filters;
Part 4. Check valves.
In this Part, Annex A is normative, Annex NA is informative.
This Part was proposed by China Food and Drug Administration.
This Part shall be under jurisdiction of the China National Standards Technical
Committee of Infusion Equipment for Medical Use (SAC/TC106).
Main drafting organization of this Part. Shandong Quality Supervision and Inspection
Center for Medical Devices.
Main drafters of this Part. Wan Min, Song Jinzi, Yao Xiujun, Wu Ping.
Fluid lines for use with pressure infusion
equipment and accessories for single use –
Part 4. Check valves
1 Scope
This Part of YY 0585.4 applies to sterile check valves for gravity feed infusion sets
and/or pressure feed infusion sets for single use.
Note. The basic requirements in this Part also applies to the built-in check valves.
2 Normative references
The provisions in following documents become the provisions of this Part of YY 0585
through reference in this Part. For dated references, the subsequent amendments
(excluding corrections) or revisions do not apply to this Part, however, parties who
reach an agreement based on this Standard are encouraged to study if the latest
versions of these documents are applicable. For undated references, the latest edition
of the referenced document applies.
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2. Lock fittings (GB/T 1962.2-2001, ISO
594-2.1998, IDT)
GB 8368 Infusion sets for single use, gravity feed (GB 8368-2005, ISO 8536-
4.2004, MOD)
GB/T 6886.1 Biological evaluation of medical devices - Part 1. Evaluation and
testing (GB/T 16886.1-2001, ISO 10993-1.1997, IDT)
YY 0466 Medical devices - Symbols to be used with medical device labels labeling
and information to be supplied (YY 0466- 2003, ISO 15223.2000, 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
8.1 Sterilization
It shall comply with GB 8368.
8.2 Pyrogen
It shall comply with GB 8368.
8.3 Biological compatibility
When evaluating the biological compatibility of check valves, it shall be performed
according to GB/T 16886.1.
9 Packaging
It shall comply with GB 8368.
10 Labels
10.1 Single packages
The single package containers shall indicating the following information.
a) Text description of the contents;
b) The graphic symbols given in YY 0466, indicating that the check valve is sterile;
c) The check valve has no pyrogen or the check valve has no bacterial endotoxin;
d) The check valve is for single use only, or equivalent texts, or graphic symbols
that comply with YY 0466;
e) Instructions for use, including warnings, such as checking whether the
protective cover is off;
f) The lot number starts with the word "batch (LOT)", or adopts the graphic symbols
given in YY 0466;
g) The words of "Safe for pressure infusion devices"1;
h) The identification marks that comply with Chapter 4 (such as YY 0585.4/ ISO
8536-12-CV-P);
i) The letter "P" that represents the pressure, its size shall be bigger than the
1 The name and type of pressure feed infusion sets shall be given by the manufacturer.
At (23 ± 2)°C and (40 ± 2)°C respectively, SUBJECT the check valve to a water
pressure of 200kPa in the counterflow direction for 15min. Check for leakage through
the check valve.
A.6 Volumetric flow rate
CONNECT the check valve with the infusion set, according to the specifications of GB
8368.
NOTE. If the requirements of 6.6 are not met, the infusion sets without the check valve shall be
tested.
A.7 Blocking performance
It shall perform two tests. one with distilled water, one with 40% glucose.
When performing tests, the check valve shall be performed at least three tests under
the states of horizontal position, vertical position and reverse vertical position.
The check valve shall be connected to the test system shown in Figure A.1.
For the check valve that is permanently installed in the fluid line, the pipe shall be cut
off, a three-way switch with the tube shall be installed. It can also decline the liquid
level of the test solution in the pipe, and make a liquid level mark.
FILL the entire system with the required test solution, avoid air bubbles, and then
perform the following steps.
a) Switch position 1
If necessary, use switch position 1 to stabilize the feed rate2 of the pump.
b) Switch position 2
KEEP the switch of the infusion set pipe on, there shall be a flow through the
check valve for 2min.
c) Switch position 3
It shall observe.
- the pressure of the pump and the check valve pipe indicated on the pressure
gauge is rising;
- the water level in the tube is moving toward the outlet end and the fluid drops
2 It is recommended to apply pressure to the system with a feed rate of 0.3mL/h.
Standard, and a footnote 1 is added to
explain this modification
used at 10°C. In addition,
the test temperature in all
other provisions is (23 ±
2)°C
A.7a) ADD a footnote, recommending a feed rate of 0.3mL/h
The technical
requirements of
international standard draft
requires to test at this rate.
After verification, it is
considered that it
necessary to recommend
this feed rate, to help
obtain comparable results
A.8.1 MODIFY (23 ± 3)°C in the international standard TO (23 ± 2)°C
Compared with A.5, adjust
the tolerance of the test
temperature to ± 2°C is
reasonable
......
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