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YY 0581.2-2011: Infusion access adapter. Part 2: Needleless access adapters
YY 0581.2-2011
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.20
C 31
Infusion access adapter - Part 2.Needleless access adapters
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 01, 2013
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3 
Introduction... 4 
1 Scope... 5 
2 Normative references... 5 
3 Terms and definitions... 5 
4 Materials... 6 
5 Physical requirements... 6 
6 Chemical requirements... 7 
7 Biological requirements... 8 
8 Microbial invasion assessment... 8 
9 Packaging... 8 
10 Marks... 8 
Annex A (Normative) Physical tests... 10 
Annex B (Normative) Chemical tests... 12 
Annex C (Informative) Clinical significance and method guide of microbial invasion
tests for needleless access adapters... 13 
Bibliography... 15 
Infusion access adapter - Part 2.Needleless access adapters
1 Scope
This Part of YY 0581 specifies the requirements and test methods for single-use self-
closing access adapters (hereinafter referred to as access adapters) in the form of non-
puncture use.
For products that are integrated with intravascular indwelling devices (such as venous
indwelling needles) and supplied as one piece, it can refer to this Part.
Backflow prevention valves specified in YY 0286.6 are not included in the scope of this
Part.
Switches specified in YY 0585.2 are not included in the scope of this Part.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) 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 8368, Infusion sets for single use - Gravity feed
GB 15810, Sterile syringes for single use
GB 15811, Sterile hypodermic needles for single use
YY/T 0466.1, Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1.General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 positive displacement
When the infusion set is pulled out from the access port, the liquid in the system will
flow in the direction of the body to avoid blood backflow caused by pulling out the
infusion set.
5.5 Access port
5.5.1 Assembly tightness
The access port shall be able to connect with the outer conical locking fitting in
accordance with GB/T 1962.2.When tested according to A.5.1, there shall be no water
or air leakage at the connection.
5.5.2 Separation force
When tested according to A.5.2, the access port shall not be separated from the external
conical locking fitting.
5.6 Fitting
The fitting of the access adapter shall be an external conical locking fitting in
accordance with GB/T 1962.2.
5.7 Positive displacement (if any)
For fittings of access adapters with nominal "positive displacement" function, when
tested according to A.6, each time when the syringe is removed from the port, there
shall be fluid flowing out of the port.
5.8 Pipelines of access adapters (if any)
5.8.1 Transparency
The transparency of the extracorporeal pipeline on the access adapter shall be easy to
observe blood return and air bubbles.
5.8.2 Flow stop clip
If there is a connecting pipeline between the access port and the fitting, there shall be a
flow stop clip on the pipeline that can reliably block the liquid path.
5.9 Inner cavity volume
When tested according to A.7, the inner cavity volume of the access adapter shall not
be greater than the marked amount.
NOTE. Except that the access port is integrated with other instruments.
6 Chemical requirements
When tested according to Annex B, the access adapter shall meet the requirements of
GB 8368.
7 Biological requirements
GB 8368 applies.
8 Microbial invasion assessment
Needleless access adapters shall be designed to facilitate clinical disinfection, so as to
prevent microorganisms from entering the sterile fluid pathway. Therefore, the access
adapter shall be evaluated for microbial intrusion.
NOTE. Annex C provides guidelines for the microbial invasion assessment of access adapters.
9 Packaging
GB 8368 applies.
10 Marks
10.1 Single packaged containers
A single package shall be marked with at least the following information.
a) Text description of the contents;
b) Access adapters are sterile;
c) Access adapters are free of pyrogen, or access adapters are free of bacterial
endotoxin;
d) Access adapters are for one-time use only, or a description of the equivalent text;
e) Batch number;
f) Expiration year and month;
g) Name or logo of manufacturer or supplier;
h) Inner cavity volume measured by the method specified in A.6, at least accurate to
0.1mL;
i) A statement that the product contains natural rubber (if any);
j) Warnings of reading the instructions for use;
Annex A
(Normative)
Physical tests
A.1 Particulate pollution
The test shall be carried out in accordance with the provisions of GB 8368.The volume
of flushing fluid shall be at least 50 times the volume of the inner cavity of the test
sample.
A.2 Connection strength
Make the test access adapter and all components bear 15N of axial static tension for
15s. Verify that each connection of the assembly can withstand the applied force.
A.3 Volume flow
Connect the access adapter to the infusion set, according to GB 8368.
NOTE. If the requirements of 5.3 are not met, the infusion set without the access adapter shall be
tested.
A.4 Leakage
A.4.1 Before the start of the test, place the entire system at the test temperature for state
adjustment. Then according to the instruction manual, use a 5mL syringe that complies
with GB 15810 to inject 5mL of water through the access port each time. Inject 30 times
in total or the number of times stated by the manufacturer (whichever is greater). The
last connection time is one day or the time stated by the manufacturer, whichever is
greater.
NOTE. According to the instruction manual, this simulated injection process also includes the
process of sterilizing the access port.
After the above process is completed, remove the syringe from the fitting.
A.4.2 At (23±1)°C and (40±1)°C, access 200kPa or 1.5 times the manufacturer's
nominal pressure (whichever is greater) from the fitting end to the inside for 15min.
Inspect the access adapter for fluid leaks.
A.4.3 Fill the access adapter with de-bubbled purified water. Connect the fitting to a
vacuum device through a suitable length of transparent anti-vacuum line. At (23±1)°C
and (40±1)°C, withstand -20kPa pressure for 15s. Inspect if air has entered the access
adapter system.
A.5 Access port
A.5.1 Tightness
A.5.1.1 Conduct according to A.4.1.
A.5.1.2 Assemble according to 5.2.1 in GB/T 1962.2-2001.At (23±1)°C and (40±1)°C,
use purified water to pass a pressure of 200kPa through the access port for 15min.
Check if water leaks at the access port connection.
A.5.1.3 Assemble according to 5.2.1 in GB/T 1962.2-2001.Connect the fitting to a
vacuum device through a suitable length of transparent anti-vacuum line. Make it
withstand the pressure of -20kPa for 15s at (23±1)℃ and (40±1)℃. Inspect if air has
entered the access adapter system.
A.5.2 S...