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YY 0581.2-2011 English PDF (YY0581.2-2011)

YY 0581.2-2011 English PDF (YY0581.2-2011)

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YY 0581.2-2011: Infusion access adapter. Part 2: Needleless access adapters

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.
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 Separation force
A.5.2.1 Carry out according to A.4.1.
A.5.2.2 Carry out the test according to 5.4 in GB/T 1962.2-2001.
A.6 Positive displacement performance
During the test steps of A.4.1, after each injection, while removing the syringe from the access port, observe whether the liquid flows out of the fitting of the access adapter. A.7 Test of inner cavity volume
Weigh the difference between the weight before and after the inner cavity of the access adapter is filled with water. Convert the cavity volume according to the density of water. Annex C
(Informative)
Clinical significance and method guide of microbial invasion tests for needleless access adapters
C.1 Clinical significance
As a substitute for heparin cap, the needleless access adapter can effectively reduce the probability of needle stick for medical personnel. However, due to the use of a needleless Luer fitting, if the fitting design is not reasonable or the disinfection method used is not appropriate, there is a risk of microbial intrusion. During clinical infusions to patients, needleless access adapters are used multiple times (such as infusions, injections, flushing). Within the interval of multiple uses, its access port is closed, so as to prevent microorganisms from the infusion environment from entering the system. However, at this time, the access port of the needleless access adapter is directly exposed to the surrounding environment, which will be contaminated by environmental microorganisms. If it is not effectively disinfected before the next use, microorganisms may enter the system and cause infection of the patient.
Whether a disinfection procedure is safe and effective depends not only on the disinfectant and method of disinfection, but also on the design of the access port of the needleless access adapter. If there are dead corners that are difficult to sterilize in the design of the access port, the dead corners cannot be effectively sterilized. Contaminated microorganisms in the dead corners may enter the sterile fluid path system.
The safety and effectiveness of disinfection is directly related to the life and health of patients and is deeply concerned by medical staff and patients. Therefore, the manufacturer needs to confirm the suitability of the access port and the sterilization procedure used, so as to be able to provide the user upon request with objective evidence that microorganisms are not infiltrated in routine use. Microbial invasion test is at the heart of this validation.
C.2 Method guides
Microbial invasion test methods shall be designed to simulate clinical use. The selection of test parameters and the setting of test procedures shall reasonably reflect the "worst- case scenario" of clinical use. At the same time, a sufficient number of samples shall be tested. Control tests shall be carried out to exclude the interference of uncertain factors. The designed general idea of the test is. Inoculate the access port of the product with the specified type and quantity of microorganisms. Disinfect the access port according to the disinfection procedures provided in the instruction manual or prescribed by

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