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YY/T 0581.2-2024 English PDF (YYT0581.2-2024)
YY/T 0581.2-2024 English PDF (YYT0581.2-2024)
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YY/T 0581.2-2024: Infusion access adapter - Part 2: Needleless access adapters
YY/T 0581.2-2024. Infusion connectors Part 2. Needleless connectors
ICS 11.040.20
CCSC31
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0581.2-2011
Infusion connectors Part 2.Needleless connectors
Released on 2024-09-29
Implementation on October 15, 2025
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 Materials and classification 2
5 Physical Requirements 2
5.1 Particle contamination 2
5.2 Connection strength 2
5.3 Volume flow 2
5.4 Leakage 2
5.5 Interface 2
5.6 Conical joint 2
5.7 Liquid Flow 2
5.8 Connecting pipes (if any) 3
5.9 Inner cavity volume 3
6 Chemical Requirements 3
7 Biology Requirements 3
8 Microbial intrusion assessment 3
9 Packaging 3
10 Sign 3
10.1 Single packaging container 3
10.2 Shelves or multi-unit containers 4
Appendix A (Normative) Physical Test 5
A.1 Particle contamination 5
A.2 Connection strength 5
A.3 Volume flow 5
A.4 Leakage 5
A.5 Interface 5
A.6 Liquid Flow 6
A.7 Inner cavity volume test 6
Appendix B (Normative) Chemical Test 7
B.1 Test solution preparation 7
B.2 Test steps 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 2 of YY/T 0581 “Infusion Connectors”. YY/T 0581 has been published in the following parts.
--- Part 1.Piercing connector (heparin cap);
--- Part 2.Needleless connectors.
This document replaces YY/T 0581.2-2011 "Infusion Connectors Part 2.Needleless Connectors" and is compatible with YY/T 0581.2-2011
Compared with the previous version, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Added the terms "balanced flow" and "negative flow" (see 3.1.2, 3.1.3);
--- Added the requirement for balanced flow (see 5.7.2);
--- Added negative flow requirements (see 5.7.3);
--- Changed the test method for volume flow rate (see A.3, A.3 of the.2011 edition);
--- Added the test method for leakage of power injection needleless connector (see A.4.4);
--- Added test method for liquid flow (see A.6).
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).
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Shandong Ande Medical Supplies Co., Ltd., Jiangxi
Sanxin Medical Technology Co., Ltd., B. Braun Medical (Suzhou) Co., Ltd., Weihai Jierui Medical Products Co., Ltd., Wuhan Zhixun Chuangyuan Technology
Technology Development Co., Ltd., Becton Dickinson Medical Devices (Shanghai) Co., Ltd., and Beijing Tiandi Hexie Technology Co., Ltd.
The main drafters of this document are. Wang Changbin, Fu Jian, Wang Ganying, Sun Yun, Zhang Xiaowei, Wu Qiyu, Huang Chenyue, Wang Wanming, Zhang Lei, Luan Tongqing,
Qi Xiaoqing and Qin Yue.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2011 as YY/T 0581.2-2011;
---This is the first revision.
introduction
Common infusion connectors on the market are divided into two types. puncture type (also known as needle connection) and non-puncture type (also known as needle-free connection).
There is also a plastic blunt needle connection type connector on the market. It is a common requirement for the interface to maintain its sealing during and after use.
The interface of the connector poses a risk of puncture debris entering the infusion system for the patient and a risk of accidental puncture needle piercing the hands of medical staff;
The piercing connector does not have the above risks of the puncture connector, but there is a risk of microorganisms invading the infusion system after repeated use.
The infusion connectors covered by YY/T 0581 are generally used for long-term intravascular indwelling catheters (such as intravenous indwelling needles, central venous catheters, etc.).
It can be used with a needle-connected or needle-free connection to inject liquid medicine into the blood vessels and to draw blood or fluid.
At the end of the infusion or between infusions of different drugs, the catheter needs to be flushed with saline through the infusion connector to flush out the residual
Medication for indwelling catheters to prevent complications, such as phlebitis. When the infusion is terminated, replace it with saline or saline with heparin.
Water is used to positively seal the catheter through a needle connector or a needleless connector to avoid blood backflow caused by pulling out the infusion device.
When the needle-free interface is connected to the 6% Luer cone lock connector, the valve is in the open state, and when it is separated from it, the valve is in the closed state.
When the infusion device is removed, the blood in the human body will flow back toward the connector. To avoid blood backflow, it is necessary to
Note. Before removing the infusion set from the interface, first use a stop clamp to block the connection between the connector and the vascular access or use positive pressure sealing.
How the tube operates.
At the moment the infusion device is removed, the liquid in the system will flow toward the human body to avoid blood reflux caused by pulling out the infusion device.
Forward flow is achieved through the mechanical valve inside the connector. The types of mechanical valves are spring piston type and elastic bladder type. The principle is that when the connector
When the connected state is changed to the disconnected state, the position and shape of the mechanical valve inside the connector changes, causing the volume of the inner cavity of the connector to change, thereby
Due to the characteristics of human blood pressure fluctuations, the mechanical valve will repeatedly undergo slight displacement or deformation, which will cause the liquid and
The human body's blood repeatedly exchanges tiny flows, eventually causing blood reflux. When using this type of connector, you need to pay attention to the
After removing the infusion set from the mouth, use a stop clamp to promptly block the connection between the connector and the vascular access.
After the infusion device is removed, the liquid in the system and the blood in the human body always maintain a balance (constant) to avoid the liquid in the system and the blood in the human body
Exchange flow and reduce blood reflux.
During long-term use, if the connector is improperly connected to the intravascular catheter, there is a risk of accidental detachment, which may cause
The patient may suffer from massive blood loss and endanger his life. Therefore, it is very important to use Luer lock connection and require a reliable connection during clinical use.
If necessary, it is recommended to give necessary warnings on the packaging of the injection connector or related products or in the instructions for use to ensure the reliability of the connection.
If the connector is integrated with an intravascular indwelling catheter (such as an intravenous indwelling needle) and other devices as a whole, the implementation of YY/T 0581 can be referred to.
This section.
The relevant contents of Appendix D in GB 8368 “Disposable Infusion Sets – Gravity Infusion Type” are applicable to this part of YY/T 0581.
YY/T 0581 "Infusion Connectors" aims to specify the performance requirements and test methods for infusion connectors and is intended to consist of two parts.
--- Part 1.Piercing connector (heparin cap).
--- Part 2.Needleless connectors.
Infusion connectors Part 2.Needleless connectors
1 Scope
This document specifies the requirements for disposable needleless connectors (hereinafter referred to as connectors) and describes the corresponding test methods.
This document applies to self-closing, disposable, needle-free connectors intended for non-puncture use.
Products that are supplied as a whole with connectors and intravascular indwelling devices (such as intravenous indwelling needles) shall refer to this document for implementation.
The backflow prevention valve specified in YY 0585.4 is not included in the scope of this document.
Switches specified in YY 0585.2 are not included in the scope of this document.
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/T 1962.2-2001 6% (Luer) cone connectors for syringes, needles and other medical devices Part 2.Locking connectors
GB/T 6682 Specifications and test methods for water used in analytical laboratories
GB 8368 Disposable infusion set gravity infusion type
GB 15810 Disposable sterile syringes
YY 0285.1-2017 Intravascular catheters Single-use sterile catheters Part 1.General requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Liquid displacement
The flow state of the liquid in the system (connector) at the moment the infusion set is pulled out from the interface.
3.1.1
Positive displacement
When the infusion device is pulled out from the interface, the liquid in the system (connector) will flow into the body.
3.1.2
Balanced flow neutral displacement
When the infusion device is pulled out from the interface, the liquid in the system (connector) and the blood in the body remain in balance (constant) and do not flow to any
Direction flow.
3.1.3
Negative displacement
The moment the infusion device is pulled out from the interface, the blood in the body will flow toward the system (connector).
3.2
Interface accessport
The liquid inlet port composed of the sealing component on the connector is suitable for connecting with the 6% (Luer) external cone locking connector of the infusion set.
Get Quotation: Click YY/T 0581.2-2024 (Self-service in 1-minute)
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Preview True-PDF (Reload/Scroll-down if blank)
YY/T 0581.2-2024: Infusion access adapter - Part 2: Needleless access adapters
YY/T 0581.2-2024. Infusion connectors Part 2. Needleless connectors
ICS 11.040.20
CCSC31
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0581.2-2011
Infusion connectors Part 2.Needleless connectors
Released on 2024-09-29
Implementation on October 15, 2025
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 Materials and classification 2
5 Physical Requirements 2
5.1 Particle contamination 2
5.2 Connection strength 2
5.3 Volume flow 2
5.4 Leakage 2
5.5 Interface 2
5.6 Conical joint 2
5.7 Liquid Flow 2
5.8 Connecting pipes (if any) 3
5.9 Inner cavity volume 3
6 Chemical Requirements 3
7 Biology Requirements 3
8 Microbial intrusion assessment 3
9 Packaging 3
10 Sign 3
10.1 Single packaging container 3
10.2 Shelves or multi-unit containers 4
Appendix A (Normative) Physical Test 5
A.1 Particle contamination 5
A.2 Connection strength 5
A.3 Volume flow 5
A.4 Leakage 5
A.5 Interface 5
A.6 Liquid Flow 6
A.7 Inner cavity volume test 6
Appendix B (Normative) Chemical Test 7
B.1 Test solution preparation 7
B.2 Test steps 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 2 of YY/T 0581 “Infusion Connectors”. YY/T 0581 has been published in the following parts.
--- Part 1.Piercing connector (heparin cap);
--- Part 2.Needleless connectors.
This document replaces YY/T 0581.2-2011 "Infusion Connectors Part 2.Needleless Connectors" and is compatible with YY/T 0581.2-2011
Compared with the previous version, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Added the terms "balanced flow" and "negative flow" (see 3.1.2, 3.1.3);
--- Added the requirement for balanced flow (see 5.7.2);
--- Added negative flow requirements (see 5.7.3);
--- Changed the test method for volume flow rate (see A.3, A.3 of the.2011 edition);
--- Added the test method for leakage of power injection needleless connector (see A.4.4);
--- Added test method for liquid flow (see A.6).
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).
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Shandong Ande Medical Supplies Co., Ltd., Jiangxi
Sanxin Medical Technology Co., Ltd., B. Braun Medical (Suzhou) Co., Ltd., Weihai Jierui Medical Products Co., Ltd., Wuhan Zhixun Chuangyuan Technology
Technology Development Co., Ltd., Becton Dickinson Medical Devices (Shanghai) Co., Ltd., and Beijing Tiandi Hexie Technology Co., Ltd.
The main drafters of this document are. Wang Changbin, Fu Jian, Wang Ganying, Sun Yun, Zhang Xiaowei, Wu Qiyu, Huang Chenyue, Wang Wanming, Zhang Lei, Luan Tongqing,
Qi Xiaoqing and Qin Yue.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2011 as YY/T 0581.2-2011;
---This is the first revision.
introduction
Common infusion connectors on the market are divided into two types. puncture type (also known as needle connection) and non-puncture type (also known as needle-free connection).
There is also a plastic blunt needle connection type connector on the market. It is a common requirement for the interface to maintain its sealing during and after use.
The interface of the connector poses a risk of puncture debris entering the infusion system for the patient and a risk of accidental puncture needle piercing the hands of medical staff;
The piercing connector does not have the above risks of the puncture connector, but there is a risk of microorganisms invading the infusion system after repeated use.
The infusion connectors covered by YY/T 0581 are generally used for long-term intravascular indwelling catheters (such as intravenous indwelling needles, central venous catheters, etc.).
It can be used with a needle-connected or needle-free connection to inject liquid medicine into the blood vessels and to draw blood or fluid.
At the end of the infusion or between infusions of different drugs, the catheter needs to be flushed with saline through the infusion connector to flush out the residual
Medication for indwelling catheters to prevent complications, such as phlebitis. When the infusion is terminated, replace it with saline or saline with heparin.
Water is used to positively seal the catheter through a needle connector or a needleless connector to avoid blood backflow caused by pulling out the infusion device.
When the needle-free interface is connected to the 6% Luer cone lock connector, the valve is in the open state, and when it is separated from it, the valve is in the closed state.
When the infusion device is removed, the blood in the human body will flow back toward the connector. To avoid blood backflow, it is necessary to
Note. Before removing the infusion set from the interface, first use a stop clamp to block the connection between the connector and the vascular access or use positive pressure sealing.
How the tube operates.
At the moment the infusion device is removed, the liquid in the system will flow toward the human body to avoid blood reflux caused by pulling out the infusion device.
Forward flow is achieved through the mechanical valve inside the connector. The types of mechanical valves are spring piston type and elastic bladder type. The principle is that when the connector
When the connected state is changed to the disconnected state, the position and shape of the mechanical valve inside the connector changes, causing the volume of the inner cavity of the connector to change, thereby
Due to the characteristics of human blood pressure fluctuations, the mechanical valve will repeatedly undergo slight displacement or deformation, which will cause the liquid and
The human body's blood repeatedly exchanges tiny flows, eventually causing blood reflux. When using this type of connector, you need to pay attention to the
After removing the infusion set from the mouth, use a stop clamp to promptly block the connection between the connector and the vascular access.
After the infusion device is removed, the liquid in the system and the blood in the human body always maintain a balance (constant) to avoid the liquid in the system and the blood in the human body
Exchange flow and reduce blood reflux.
During long-term use, if the connector is improperly connected to the intravascular catheter, there is a risk of accidental detachment, which may cause
The patient may suffer from massive blood loss and endanger his life. Therefore, it is very important to use Luer lock connection and require a reliable connection during clinical use.
If necessary, it is recommended to give necessary warnings on the packaging of the injection connector or related products or in the instructions for use to ensure the reliability of the connection.
If the connector is integrated with an intravascular indwelling catheter (such as an intravenous indwelling needle) and other devices as a whole, the implementation of YY/T 0581 can be referred to.
This section.
The relevant contents of Appendix D in GB 8368 “Disposable Infusion Sets – Gravity Infusion Type” are applicable to this part of YY/T 0581.
YY/T 0581 "Infusion Connectors" aims to specify the performance requirements and test methods for infusion connectors and is intended to consist of two parts.
--- Part 1.Piercing connector (heparin cap).
--- Part 2.Needleless connectors.
Infusion connectors Part 2.Needleless connectors
1 Scope
This document specifies the requirements for disposable needleless connectors (hereinafter referred to as connectors) and describes the corresponding test methods.
This document applies to self-closing, disposable, needle-free connectors intended for non-puncture use.
Products that are supplied as a whole with connectors and intravascular indwelling devices (such as intravenous indwelling needles) shall refer to this document for implementation.
The backflow prevention valve specified in YY 0585.4 is not included in the scope of this document.
Switches specified in YY 0585.2 are not included in the scope of this document.
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/T 1962.2-2001 6% (Luer) cone connectors for syringes, needles and other medical devices Part 2.Locking connectors
GB/T 6682 Specifications and test methods for water used in analytical laboratories
GB 8368 Disposable infusion set gravity infusion type
GB 15810 Disposable sterile syringes
YY 0285.1-2017 Intravascular catheters Single-use sterile catheters Part 1.General requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Liquid displacement
The flow state of the liquid in the system (connector) at the moment the infusion set is pulled out from the interface.
3.1.1
Positive displacement
When the infusion device is pulled out from the interface, the liquid in the system (connector) will flow into the body.
3.1.2
Balanced flow neutral displacement
When the infusion device is pulled out from the interface, the liquid in the system (connector) and the blood in the body remain in balance (constant) and do not flow to any
Direction flow.
3.1.3
Negative displacement
The moment the infusion device is pulled out from the interface, the blood in the body will flow toward the system (connector).
3.2
Interface accessport
The liquid inlet port composed of the sealing component on the connector is suitable for connecting with the 6% (Luer) external cone locking connector of the infusion set.
