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GB
NATIONAL STANDARD OF
C 31
GB 15811-2016
Replacing GB 15811-2001
一次性使用无菌注射针
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GB 15811-2016
Table of Contents
Foreword .......................................................................................................... 3
1 Scope ......................................................................................................... 5
5 Materials ..................................................................................................... 8
9 Packaging................................................................................................. 13
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GB 15811-2016
Foreword
This Standard was drafted in accordance with the rules given in GB/T
1.1-2009.
- deleted 4.3.1 Needle tube rigidity, 4.3.2 Needle tube toughness and
4.3.3 Needle tube corrosion resistance terms;
This Standard uses redrafting method to modify and adopt ISO 7864:1993
Sterile hypodermic needles for single use. The consistency with ISO 7864:
1993 is not equivalent.
Attention is drawn to the possibility that some of the elements of this Standard
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
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GB 15811-2016
1 Scope
This Standard specifies the requirements for sterile hypodermic needles for
single use of which the nominal outer diameters of needle tube are 0.3mm ~
1.2mm (hereinafter referred to as syringe needles).
The syringe needles specified in this Standard shall be matched with sterile
hypodermic needles for single use of GB 15810. They are also suitable for
other appropriate injection equipment, as human skin, subcutaneous, muscle,
vein and other liquid injections.
The sterile hypodermic needles for single use of disposable sterile syringes in
non-sterile state shall refer to this Standard.
2 Normative references
GB/T 6682, Water for analytical laboratory use - Specification and test
methods (GB/T 6682-2008, ISO 3696:1987, MOD)
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GB 15811-2016
5 Materials
5.1 Tubes for the manufacture of injection needles shall meet the
requirements of GB/T 18457-2015.
NOTE: Each production lot of needles shall have information on rigidity, toughness and
corrosion resistance.
5.2 The materials used to make the needle seat shall meet the
requirements of Clause 7 and Clause 8.
6 Physical properties
6.1 Cleanness
The syringe needle shall use the colors of needle seat and/or jacket as the
mark of nominal outer diameter of needle tube in according to the
requirements of YY/T 0296.
6.3 Uprightness
Visually observe the connection of needle seat and needle tube that shall be
upright. The needle tube shall not be obviously skewed.
The connection between needle seat and needle tube shall be solid. Fix the
syringe needle tube on a special instrument. Use needle seat to allocate
direction and carry out the impact-free pull-off test under the load specified in
Table 1. Both must not be loose or separated.
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GB 15811-2016
The total content of barium, chromium, copper, lead and tin in the testing
solution shall not exceed 5 μg/mL when measured by atomic absorption
spectrophotometry (AAS) or equivalent method. Cadmium content shall not
exceed 0.1 μg/mL.
When carrying out the test according to the method specified in 5.6.1 of GB/T
14233.1-2008, the color of the testing solution shall not exceed the color of
the standard control solution at a concentration of 5 μg/mL.
8 Biological properties
Immerse 25 syringe needles with jacket pulled off into 250 mL of sterile,
pyrogen-free 0.9% sodium chloride solution. Maintain temperature constant
at 37°C ± 1°C for 1h. Take out syringe needle to obtain the testing solution.
The testing solution must not be stored for more than 2h.
8.2 Sterilization
NOTE: GB/T 14233.2 specifies sterile test method. This method applies to type test not
exit-factory inspection. Suitable sterilization and exit-factory sterile test methods shall refer to
GB 18279 or GB 18280.
8.4 Hemolysis
8.5 Biocompatibility
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GB 15811-2016
syringe needles.
9 Packaging
Each piece of syringe needle shall be sealed and packed in the primary
packaging. The packaging materials and design shall ensure the color code
inside visible. When using ethylene oxide sterilization, the primary packaging
of syringe needle shall use packaging material with one side of dialysis paper
the other of plastic material or with dialysis papers of both sides. This
Standard encourages the use of better dialysis packaging materials.
Packaging materials shall not adversely affect the contents. The packaging
material and design shall ensure that:
b) when contents are removed from the package, the risk of contamination
of the contents is minimal;
During normal handling, transport and storage, the contents of the big
packaging shall be adequately protected.
10 Marks
10.1 General
The mark symbols shall be consistent with the provisions of YY/T 0466.1.
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GB 15811-2016
d) failure years;
e) failure years;
e) failure years;
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GB 15811-2016
B.2.2.1 Linear drive speed: 50 mm/min ~ 250 mm/min, the average speed
accuracy of ±5% (set value).
B.3.1 Place the testing needle and simulated skin at 22°C ± 2°C for at least
24 h and test at the same temperature.
B.3.2 Measure the device as shown in Figure B.1. Clamp the appropriate
size of the simulated skin (B.2.3) in the fixture, without any significant
stretching or compressive force exerted on the simulated skin.
B.3.3 Mount the testing needle on the testing device (B.2.1), with its axis
perpendicular to the surface of the simulated skin (B.2.3), the tip pointing to
the center of circular puncture zone.
B.3.4 Set the moving speed the testing device (B.2.1) to 100 mm/min.
B.3.6 While puncturing in the membrane, measure the maximum peak force
or record the force/displacement map.
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