YY/T 0581.2-2024 PDF English
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Infusion access adapter - Part 2: Needleless access adapters
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| YY 0581.2-2011 | English | 215 |
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Infusion access adapter. Part 2: Needleless access adapters
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YY/T 0581.2-2024: PDF in English (YYT 0581.2-2024) YY/T 0581.2-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.20
CCS C 31
Replacing YY/T 0581.2-2011
Infusion Access Adapter - Part 2.Needleless Access Adapters
ISSUED ON. SEPTEMBER 29, 2024
IMPLEMENTED ON. OCTOBER 15, 2025
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 7
2 Normative References... 7
3 Terms and Definitions... 7
4 Materials and Classification... 8
5 Physical Requirements... 8
5.1 Particle Contamination... 8
5.2 Connection Strength... 9
5.3 Volume Flow... 9
5.4 Leakage... 9
5.5 Access Port... 9
5.6 Conical fitting... 9
5.7 Liquid displacement... 9
5.8 Tubing of Access Adapters (if any)... 10
5.9 Inner Cavity Volume... 10
6 Chemical Requirements... 10
7 Biological Requirements... 10
8 Evaluation of Microbial Ingress... 10
9 Packaging... 10
10 Marking... 11
10.1 Single Packaging Containers... 11
10.2 Shelves or Multi-unit Containers... 11
Appendix A (normative) Physical Test... 13
A.1 Particle Contamination... 13
A.2 Connection Strength... 13
A.3 Volume Flow... 13
A.4 Leakage... 13
A.5 Access Port... 14
A.6 Liquid Displacement... 14
A.7 Inner Cavity Volume Test... 15
Appendix B (normative) Chemical Test... 16
B.1 Preparation of Test Liquid... 16
B.2 Test Steps... 16
Bibliography... 17
Infusion Access Adapter - Part 2.Needleless Access Adapters
1 Scope
This document specifies the requirements for disposable needleless access adapters (hereinafter
referred to as access adapters) and describes the corresponding test methods.
This document applies to self-closing and disposable needleless access adapters intended for
non-puncture use.
Products that are supplied as a whole with access adapters and intravascular indwelling devices
(for example, intravenous indwelling needles) shall refer to this document for implementation.
The anti-backflow 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 indispensable clauses of this document
through the normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 1962.2-2001 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain
Other Medical Equipment - Part 2.Lock Fittings
GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods
GB 8368 Infusion Sets for Single Use - Gravity Feed
GB 15810 Sterile Hypodermic Syringes for Single Use
YY 0285.1-2017 Intravascular Catheters - Sterile and Single-use Catheters - Part 1.General
Requirements
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 liquid displacement
The flow state of the liquid in the system (access adapter) at the moment the infusion device is
pulled out from the access port.
with the provisions of A.1 in Appendix A, the contamination index shall not exceed 90.
5.2 Connection Strength
When tested in accordance with the provisions of A.2, the connections between the access
adapters and all components shall be able to withstand a static tensile force of at least 15 N for
15 s.
5.3 Volume Flow
When tested in accordance with the provisions of A.3, the volume flow shall not be less than
the nominal value, which is expressed in (mL/min).
5.4 Leakage
When tested in accordance with the provisions of A.4, there shall be no water or air leakage.
5.5 Access Port
5.5.1 Assembly fitness
The access port shall be able to connect with the external conical lock fitting that complies with
GB/T 1962.2.When tested in accordance with the provisions of A.5.1, there shall be no water
or air leakage at the connection.
5.5.2 Separating force
When tested in accordance with the provisions of A.5.2, the access port and the standard
external conical fitting shall not separate.
5.6 Conical fitting
The conical fittings of the access adapters shall be external conical lock fittings that comply
with GB/T 1962.2.
5.7 Liquid displacement
5.7.1 Positive displacement
For nominal “positive displacement” access adapters, when tested in accordance with the
provisions of A.6, each time the syringe is removed from the access port, the volume of liquid
outward discharged from the access adapters shall be greater than 0.01 mL.
5.7.2 Neutral displacement
For nominal “neutral displacement” access adapters, when tested in accordance with the
provisions of A.6, each time the syringe is removed from the access port, the volume of liquid
outward discharged from the access adapters or inward back-flowed of the access adapters shall
be 0.01 mL.
5.7.3 Negative displacement
For nominal “negative displacement” access adapters, when tested in accordance with the
provisions of A.6, each time the syringe is removed from the access port, the volume of liquid
inward back-flowed of the access adapters shall be greater than 0.01 mL.
5.8 Tubing of Access Adapters (if any)
5.8.1 Transparency
The transparency of the extracorporeal tubing on the access adapters shall facilitate the
observation of blood return and bubbles.
5.8.2 Stop clamp
If there is a tubing connecting between the access port and the conical fitting, there should be a
stop clamp on the tubing that can reliably block the fluid lines.
5.9 Inner Cavity Volume
When tested in accordance with the provisions of A.7, the inner cavity volume of the access
adapters shall not be greater than the nominal value.
NOTE. this is not applicable if the access port is integrated with other devices.
6 Chemical Requirements
When tested in accordance with the provisions Appendix B, the access adapters shall comply
with the requirements of GB 8368.
7 Biological Requirements
GB 8368 applies.
8 Evaluation of Microbial Ingress
The design of the access adapter products shall be conducive to clinical disinfection, thereby
preventing microorganisms from entering the sterile liquid channel, so the access adapters shall
be evaluated for microbial ingress.
NOTE. YY/T 0923 provides guidance on the evaluation of microbial ingress on access adapters.
9 Packaging
GB 8368 applies.
Appendix A
(normative)
Physical Test
A.1 Particle Contamination
The test is carried out in accordance with the provisions of GB 8368.The volume of the flushing
fluid shall be at least 50 times the inner cavity volume of the test sample.
A.2 Connection Strength
Subject the access adapter under test and all components to an axial static tensile force of 15 N
for 15 s to test whether the connections of the components can withstand the applied force.
A.3 Volume Flow
In accordance with the provisions of Appendix E in YY 0285.1-2017, make the following
modifications to the test instrument.
---The 6% (Luer) external conical fitting (Assembly 6 in Figure E.1 of YY 0285.1-2017)
is modified into a 6% (Luer) external conical lock fitting.
Or test in accordance with the method specified by the manufacturer.
A.4 Leakage
A.4.1 Before the test begins, place the entire system at the test temperature for state adjustment.
Then, follow the operating procedures in the instructions for use, and use a 5 mL syringe that
complies with the provisions of GB 15810 to inject 5 mL of purified water inside through the
access port each time. A total of 30 injections or the number of injections specified by the
manufacturer (whichever is greater) are given, with the last connection time being 24 h or the
time specified by the manufacturer (whichever is greater).
NOTE. in accordance with the instructions for use, this simulated injection process also includes
the process of disinfecting the access port before each injection.
After completing the above process, remove the syringe from the access port.
A.4.2 At (23 1) C and (40 1) C, pass a pressure of 200 kPa from the end of the conical
fitting to the inside for 15 min and check whether the access adapter manifests any liquid
leakage.
A.4.3 Fill the access adapter with purified water, in which bubbles have been removed. After
passing the conical fitting through a transparent vacuum-resistant tubing of an appropriate
length, connect it to a vacuum device. It is subjected to a pressure of 20 kPa for 15 seconds at
(23 1) °C and (40 1) °C. Check whether air enters the access adapter system.
A.4.4 For nominal “hydrodynamic injection” access adapters, at (23 1) C and (40 1) C,
pass the manufacturer’s nominal maximum pressure from the access port of the access adapter
to the inside for 30 s. Check the access adapter manifests any liquid leakage.
A.5 Access Port
A.5.1 Fitness
A.5.1.1 Follow A.4.1.
A.5.1.2 Assemble in accordance with 5.2.1 in GB/T 1962.2-2001.At (23 1) C and (40 1)
C, use purified water to pass 200 kPa or 1.5 times the manufacturer’s nominal pressure
(whichever is greater) inside through the access port for 15 minutes. Check whether there is
water leakage at the access port connection.
A.5.1.3 Assemble in accordance with 5.2.1 of GB/T 1962.2-2001.After passing the conical
fitting through a transparent vacuum-resistant tubing of an appropriate length, connect it to a
vacuum device. It is subjected to a pressure of 20 kPa for 15 seconds at (23 1) °C and (40
1) °C. Check whether air enters the access adapter system.
A.5.2 Separating force
A.5.2.1 Perform in accordance with A.4.1.
A.5.2.2 In accordance with 5.4 in GB/T 1962.2-2001, carry out the test.
A.6 Liquid Displacement
A.6.1 Principle
Use a suitable connector to connect a pipette (or capillary glass tube) with a minimum division
value of not greater than 0.01 mL to the conical fitting of the needleless access adapter. Take a
syringe to absorb enough test liquid and connect it to the access port of the needleless access
adapter. After flushing the needleless access adapter and the inner cavity of the pipette,
withdraw the syringe and observe the position change of the liquid level in the pipette.
A.6.2 Test liquid
Distilled or deionized water or other clinically suitable medium, to which, colorants, for
example, red or blue food dye may be added.
A.6.3 Test apparatus
A.6.3.1 Pipette, with a minimum division value of not greater than 0.01 mL.
A.6.3.2 Connector, used to connect the pipette and the access adapter.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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