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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...