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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. Disposable fluid circuits and accessories for pressure infusion equipment Part 4. Anti-reflux valve
ICS 11.040.20
CCSC31
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0585.4-2009
Disposable fluid circuits and accessories for pressure infusion equipment
Part 4.Backflow prevention valves
singleuse-Part 4.Checkvalves
Released on 2024-07-08
2027-07-20 Implementation
The State Drug Administration issued
Table of Contents
Preface III
Introduction IV
1 Range 1
2 Normative references 1
3 Terms and Definitions 1
4 Mark 2
5 Materials 2
6 Physical Requirements 2
6.1 Particle contamination 2
6.2 Leakage 2
6.3 Compatibility with YY/T 0916 (all parts) 2
6.4 Backflow pressure impedance 2
6.5 Flow rate 3
6.6 Blocking performance 3
6.7 Opening pressure 3
6.8 Protective cover 3
7 Chemical Requirements 3
8 Biology Requirements 3
8.1 General 3
8.2 Sterility 3
8.3 Pyrogens 3
9 Tags 3
9.1 General 3
9.2 Single Packaging 3
9.3 Rack or multi-unit packaging 4
10 Packaging 4
11 Disposal 4
Appendix A (Normative) Physical Test 5
A.1 General 5
A.2 Particle contamination test 5
A.3 Leakage test 5
A.4 Backflow pressure impedance test 5
A.5 Flow rate test 5
A.6 Blocking performance test 5
A.7 Determination of opening pressure 7
References 8
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is part 4 of YY 0585 "Disposable fluid circuits and accessories for pressure infusion equipment". YY 0585 has been published
The following parts.
--- Part 1.Liquid circuit;
--- Part 2.Annex;
--- Part 3.Filters;
--- Part 4.Backflow prevention valve.
This document replaces YY 0585.4-2009 "Disposable fluid circuits and accessories for pressure infusion devices Part 4.Backflow prevention
Compared with YY 0585.4-2009, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Changed "Terms and Definitions" (see Chapter 3, Chapter 3 of the.2009 edition);
--- Changed "Marking" (see Chapter 4, Chapter 4 of the.2009 edition);
--- Deleted "tensile strength" (see 6.2 of the.2009 edition);
--- Changed "Compatibility of YY/T 0916 (all parts)" (see 6.3, 6.4 of the.2009 edition);
--- Changed "protective cover" (see 6.8, 6.9 of the.2009 edition);
--- Change the requirements for "labeling" (see Chapter 9, Chapter 10 of the.2009 edition);
--- Added "Disposal" (see Chapter 11);
--- Changed the particle contamination test (see A.2, A.1 of the.2009 edition);
--- The leakage test has been changed (see A.3, A.3 of the.2009 edition);
--- Changed the blocking performance test (see A.6, A.7 of the.2009 edition);
--- Changed the opening pressure test (see A.7, A.8 of the.2009 edition).
This document is modified to adopt ISO 8536-12.2021 "Medical infusion sets - Part 12.Single-use anti-reflux valves".
The technical differences between this document and ISO 8336-12.2021 and their reasons are as follows.
--- ISO 8536-4 (see 6.5, Chapter 7, 8.2, 8.3, Chapter 10, Appendix A) is replaced by the normative reference GB 8368 to apply
According to my country's technical conditions;
--- ISO 7886-1 (see Figure A.1) is replaced by the normative reference GB 15810 to adapt to my country's technical conditions;
--- ISO 10993-1 (see 8.1) was replaced by the normative reference GB/T 16886.1 to adapt to my country's technical conditions;
--- ISO 15223-1 (see Chapter 9) was replaced by the normative reference YY/T 0466.1 to adapt to my country's technical conditions;
--- ISO 80369 (see 6.3) was replaced by the normatively referenced YY/T 0916 (all parts) to adapt to my country's technical conditions;
--- Added "Eluent Preparation" (see A.2.2) to suit my country's national conditions;
--- The flow rate test method (see A.5) has been changed to suit my country's national conditions.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC106).
The previous versions of this document and the documents it replaces are as follows.
---First issued in.2009 as YY 0585.4-2009;
---This is the first revision.
introduction
The anti-reflux valve is a one-way valve used in infusion equipment. It can be connected in series in the infusion line to prevent blood return or reflux caused by misoperation;
The anti-reflux valve can be supplied separately or as an infusion valve.
The component of the infusion set is supplied with the infusion set (referred to in this document as the "integrated anti-reflux valve").
YY 0585 "Disposable fluid circuits and accessories for pressure infusion equipment" is intended to specify disposable fluid circuits and accessories for pressure infusion equipment.
The performance requirements and test methods of its accessories are planned to consist of four parts.
--- Part 1.Fluid circuit. Specifies the physical, chemical and biological requirements for disposable sterile fluid circuits for pressure infusion equipment.
--- Part 2.Accessories. Specifies the physical, chemical and biological requirements for accessories used in pressure infusion equipment.
--- Part 3.Filters. Specifies the design, physical, chemical and biological requirements for filters used in pressure infusion equipment.
--- Part 4.Anti-backflow valve. Specifies the properties of anti-backflow valves for single-use gravity infusion and/or pressure infusion infusion sets.
Can request.
Disposable fluid circuits and accessories for pressure infusion equipment
Part 4.Backflow prevention valves
1 Scope
This document specifies the performance requirements for backflow prevention valves for single-use gravity-fed and/or pressure-fed infusion sets.
This document applies to single-use gravity infusion and/or pressure infusion anti-reflux valves for infusion sets. The basic requirements also apply to built-in
Backflow prevention valve.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB 8368 Single-use infusion set gravity infusion type (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 in the risk management process (GB/T 16886.1-
2022,ISO 10993-1.2018,IDT)
YY/T 0466.1 Symbols for medical devices used to provide information by manufacturers Part 1.General requirements (YY/T 0466.1-
2023,ISO 15223-1.2021,MOD)
YY/T 0916 (all parts) Small-bore connectors for medical liquids and gases [ISO 80369 (all parts)]
Note. YY/T 0916.1-2021 Small-bore connectors for medical liquids and gases Part 1.General requirements (ISO 80369-1.2018, IDT);
YY/T 0916.3-2022 Small-bore connectors for medical liquids and gases Part 3.Connectors for gastrointestinal applications (ISO 80369-3.2016,
IDT);
YY/T 0916.6-2022 Small-bore connectors for medical liquids and gases Part 6.Connectors for axial applications (ISO 80369-6.2016,
IDT);
YY/T 0916.20-2019 Small-bore connectors for medical liquids and gases Part 20.Common test methods (ISO 80369-20.2015,
IDT).
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Blocking
Prevent backflow through the anti-backflow valve (3.2).
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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