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GB 15811-2016

Translated English of Chinese Standard: GB15811-2016


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GB
NATIONAL STANDARD OF

THE PEOPLE’S REPUBLIC OF CHINA


ICS 11.040.20

C 31

GB 15811-2016
Replacing GB 15811-2001

Sterile hypodermic needles for single use


(ISO 7864:1993, NEQ)

一次性使用无菌注射针

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Issued on: June 14, 2016 Implemented on: January 1, 2018


Issued by: General Administration of Quality Supervision, Inspection
and Quarantine;
Standardization Administration Committee.

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GB 15811-2016

Table of Contents

Foreword .......................................................................................................... 3 

1 Scope ......................................................................................................... 5 

2 Normative references ................................................................................. 5 

3 Structural type and naming......................................................................... 6 

4 Marking example ........................................................................................ 7 

5 Materials ..................................................................................................... 8 

6 Physical properties ..................................................................................... 8 

7 Chemical properties ................................................................................. 11 

8 Biological properties ................................................................................. 12 

9 Packaging................................................................................................. 13 

10 Marks ..................................................................................................... 13 

11 Inspection rules ...................................................................................... 15 

12 Storage ................................................................................................... 15 

Annex A (informative) Flow testing device ..................................................... 16 

Annex B (informative) Test and evaluation method for syringe needle

puncture force ................................................................................................ 17 

Annex C (Normative) Biological evaluation .................................................... 20 

Annex D (informative) Inspection rules .......................................................... 21 

Bibliography ................................................................................................... 22 

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GB 15811-2016

Foreword

All technical content of this Standard is mandatory.

This Standard was drafted in accordance with the rules given in GB/T
1.1-2009.

This Standard replaces GB 15811-2001 Sterile hypodermic needles for single


use. Compared with GB 15811-2001, the main technical changes are as
follows:

- added Clause 5 “Materials”;

- added Annex A Injection needle flow test device schematic;

- provided needle puncture force requirements in Annex B (informative)


Needle puncture needle requirements and test methods;

- deleted 4.3.1 Needle tube rigidity, 4.3.2 Needle tube toughness and
4.3.3 Needle tube corrosion resistance terms;

- added requirements that paper dialysis packaging materials shall be


used for primary packaging;

- modified Annex D Inspection rules.

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.

This Standard was proposed by China Food and Drug Administration.

This Standard shall be under the jurisdiction of National Technical Committee


on Medical Syringes (Needles) of Standardization Administration of China
(SAC/TC 95).

The drafting organizations of this Standard: Zhejiang Kant Lai Medical


Devices Co., Ltd., Shanghai Medical Device Testing Institute.

Main drafters of this Standard: Zhang Honghui, Ding Biao.

Versions of standard substituted by this Standard are:

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GB 15811-2016

Sterile hypodermic needles for single use

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.

This Standard is not applicable to disposable dental needles.

The sterile hypodermic needles for single use of disposable sterile syringes in
non-sterile state shall refer to this Standard.

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 1962.1-2015, Conical fittings with a 6% (Luer) taper for syringes,


needles and certain other medical equipment - Part 1: General
requirement (ISO 594-1:1986, IDT)

GB/T 1962.2-2001, Conical fittings with a 6% (Luer) taper for syringes,


needles and certain other medical equipment - Part 2: Lock fittings (ISO
594-2:1998, IDT)

GB/T 6682, Water for analytical laboratory use - Specification and test
methods (GB/T 6682-2008, ISO 3696:1987, MOD)

GB/T 14233.1-2008, Test methods for infusion transfusion injection


equipment for medical use - Part 1: Chemical analysis methods

GB/T 14233.2-2005, Test methods for infusion, transfusion, injection


equipment for medical use - Part 2: Biological test methods

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GB 15811-2016

marked as: 0.7 × 30 TWLB.

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

In 300lx ~ 700lx illumination, with normal or corrected vision, without


amplification, observe the needle tube; and under 2.5 times magnification,
observe the needle seat surface that shall be clean, without foreign matters.

6.2 Color code

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.

6.4 Connection fastness

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

7.3 Total heavy metal content (metal ions)

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

8.1 Preparation of testing solution

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

Every syringe needle through primary packaging shall choose appropriate


method for sterilization. The sterilization process shall be confirmed and in
routine control to ensure that the probability of bacterial survival on the
product is less than 10-6. Confirmation of the sterilization process shall be
documented.

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.

8.3 Bacterial endotoxin

When testing according to the method of GB/T 14233.2-2005, the bacterial


endotoxin content shall be less than 20 EU/piece.

8.4 Hemolysis

When testing according to the method of GB/T 14233.2-2005, the hemolysis


rate of syringe needle shall be less than 5%.

8.5 Biocompatibility

Perform biological evaluation for syringe needle according to the


requirements of GB/T 16886.1. Evaluation results shall indicate no biological
hazards. Annex C gives the basic requirements for biological evaluation of

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GB 15811-2016

syringe needles.

9 Packaging

9.1 Primary 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:

a) in dry, clean and well-ventilated storage conditions, ensure the contents


are aseptic;

b) when contents are removed from the package, the risk of contamination
of the contents is minimal;

c) during normal handling, transport and storage, the contents of the


primary packaging shall be adequately protected;

d) once opened, the package cannot be easily resealed and shall be


clearly torn.

9.2 Medium-size packaging

One or more primary packages shall be packed in a medium-size packaging.

During normal handling, transport and storage, the contents of the


medium-size packaging shall be adequately protected.

9.2 Big packaging

One or more medium-size packages shall be packed in a big packaging.

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

10.2 Primary packaging

The primary packaging shall have at least the following marks:

a) product name and marks required by Clause 4;

b) "sterile" or equivalent mark;

c) lot number starts with "Lot" or LOT;

d) failure years;

e) "one-time use" or equivalent mark;

f) name of manufacturer and/or supplier.

10.3 Medium-size packaging

The medium-size packaging shall have at least the following marks:

a) product name and marks required by Clause 4;

b) "sterile" and sterilization method or equivalent mark;

c) "one-time use" or equivalent mark;

d) lot number starts with "Lot" or LOT;

e) failure years;

f) name of manufacturer and/or supplier name and address.

10.4 Big packaging

If the medium-size packaging is packed in a big packaging, the big packaging


shall have at least the following marks:

a) product name and marks required by Clause 4;

b) "sterile" or equivalent mark;

c) "one-time use" or equivalent mark;

d) lot number starts with "Lot" or LOT;

e) failure years;

f) requirements for handling, storage and transport;

g) name of manufacturer and/or supplier name and address.

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GB 15811-2016

B.2.2 Test equipment technical indicators

B.2.2.1 Linear drive speed: 50 mm/min ~ 250 mm/min, the average speed
accuracy of ±5% (set value).

B.2.2.2 Pressure sensor measuring range: 0~50 (0~5) N, accuracy of ± 0.5%


(full scale).

B.2.3 Simulated skin material

B.2.3.1 Material: polyurethane film.

B.2.3.2 Thickness: 0.35mm ± 0.05mm.

B.2.3.3 Hardness: Shore A (85 ± 10).

B.2.3.4 Exposed area (after clamping) is equal to Φ10 mm.

B.3 Testing procedures

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.3.5 Start the test device.

B.3.6 While puncturing in the membrane, measure the maximum peak force
or record the force/displacement map.

NOTE: Do not use punctured membrane in circular puncture areas.

B.4 Piercing force

The recommended needle puncture forces are shown in Table B.1.

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