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GB 15811: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 15811-2025 | English | 380 |
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Sterile hypodermic needles for single use
| Valid |
| GB 15811-2016 | English | 135 |
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Sterile hypodermic needles for single use
| Valid |
| GB 15811-2001 | English | 599 |
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Sterile hypodermic needles for single use
| Obsolete |
| GB 15811-1995 | English | 479 |
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4 days
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Sterile hypodermic needles for single use
| Obsolete |
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GB 15811-2025: Sterile hypodermic needles for single use
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB15811-2025
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
CCS C 31
Replacing GB 15811-2016
Sterile Hypodermic Needles for Single Use
Issued on: AUGUST 29, 2025
Implemented on: SEPTEMBER 1, 2028
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 4
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 6
4 Examples of Marking... 6
4.1 Tubular Needle... 6
4.2 Tapered Needle... 7
4.3 Geometric Figures and Naming of Needle Tip... 8
5 Materials... 9
6 Physical Requirements... 9
6.1 Cleanliness... 9
6.2 Color Coding... 9
6.3 Straightness... 9
6.4 Connection Firmness... 9
6.5 Unobstructed... 10
6.6 Fitness of Needle Hub and Sheath... 11
6.7 Needle Tip... 11
6.8 Needle Tubing... 12
6.9 Needle Hub... 12
6.10 Protection against Sharps Injury... 13
7 Chemical Requirements... 13
7.1 Preparation of Test Solution... 13
7.2 pH... 13
7.3 Total Heavy Metal Content (metal ions)... 13
8 Biological Requirements... 13
8.1 General Requirements... 13
8.2 Sterility... 13
8.3 Bacterial Endotoxins... 14
9 Packaging... 14
9.1 Initial Packaging... 14
9.2 Medium Packaging... 14
9.3 Large Packaging... 14
10 Marking... 15
Sterile Hypodermic Needles for Single Use
1 Scope
This document specifies the requirements for sterile hypodermic needles for single use
(hereinafter referred to as the “hypodermic needles”) whose needle tubing has a nominal outer
diameter of 0.18 mm ~ 1.2 mm.
This document applies to hypodermic needles used in conjunction with GB 15810 and other
suitable injection devices for intradermal, subcutaneous, intramuscular and intravenous
injection of liquid medications. For single-use hypodermic needles used in conjunction with
GB 15810 and provided in a non-sterile state, this document may be taken as a reference.
This document does not apply to single-use dental syringe needles, needles used with needle
injection systems (NIS) or single-use dispensing needles.
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 6682 Water for Analytical Laboratory Use - Specification and Test Methods
GB/T 14233.1-2022 Test Methods for Infusion, Transfusion, Injection Equipment for Medical
Use - Part 1.Chemical Analysis Methods
GB/T 14233.3 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use -
Part 3.Microbiological Test Methods
GB 15810 Sterile Syringes for Single Use
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1.Evaluation and Testing within
a Risk Management Process
GB/T 18457-2024 Stainless Steel Needle Tubing for the Manufacture of Medical Devices -
Requirements and Test Methods
GB/T 42063 Sharps Injury Protection - Requirements and Test Methods - Sharps Projection
Features for Single-use Hypodermic Needles, Introducers for Catheters and Needles Used for
Blood Sampling
YY/T 0296 Hypodermic Needles for Single Use - Color Coding for Identification
YY/T 0466.1 Medical Devices - Symbols to be Used with Information to be Supplied by the
Manufacturer - Part 1.General Requirements
YY/T 0916.7 Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part
7.Connectors for Intravascular or Hypodermic Applications
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 tubular needle
A hypodermic needle with tubular needle tubing.
NOTE. the outer diameter of the needle tubing is a specified nominal dimension.
3.2 tapered needle
A hypodermic needle with tapered needle tubing.
NOTE. the outer diameter of the needle tubing spans at least two consecutive specified nominal
dimensions.
4 Examples of Marking
4.1 Tubular Needle
The marking (specification) for a tubular needle consists of the nominal outer diameter of the
needle tubing, the nominal length (L in Figure 1), the tube wall type, and the first bevel angle
(α). The outer diameter and length are expressed in millimeters (mm). The tube wall type is
indicated as RW (regular wall), TW (thin wall), ETW (extra-thin wall) or UTW (ultra-thin wall).
The first bevel angle is indicated as LB (long bevel angle) or SB (short bevel angle). A
schematic diagram of the tubular needle is shown in Figure 1.
EXAMPLE. a tubular needle with a nominal outer diameter of 0.7 mm for the needle tubing, a length
(L) of 30 mm, a thin wall tube type, and a long first bevel angle is marked as.
5 Materials
5.1 The materials used to manufacture needle tubing shall comply with the requirements of
GB/T 18457-2024.
NOTE. for tapered needles, the manufacturer shall conduct appropriate testing of the rigidity and
toughness of the needle tubing and implement a corresponding risk assessment in
accordance with GB/T 42062-2022.
5.2 The materials used to manufacture the needle hub shall satisfy the requirements of Chapter
7 and Chapter 8.
6 Physical Requirements
6.1 Cleanliness
Under the illumination of 300 lx ~ 700 lx, with normal or corrected vision and without
magnification, observe the surface of the needle tubing, and at 2.5 magnification, observe the
surface of the needle hub, both shall be clean and free of foreign matter.
6.2 Color Coding
For the hypodermic needles, the nominal outer diameter of the needle tubing shall be identified
by the color of the needle hub and / or sheath, in accordance with the requirements of YY/T
0296.
NOTE. for tapered needles, the nominal outer diameter of the needle tip shall be used as the basis
for identifying the color coding.
6.3 Straightness
Visually inspect the connection between the needle hub and the needle tubing. It shall be straight,
and the needle tubing shall not be noticeably skewed.
6.4 Connection Firmness
The connection between the needle hub and the needle tubing shall be firm. Secure the needle
tubing to a dedicated instrument, and in the direction of needle hub removal, under the load
specified in Table 1, perform a non-impact pull-out test. The two shall not loosen or separate.
For tapered needles, use the outer diameter of the needle tubing at the needle hub end as shown
in Figure 2 as the nominal outer diameter. Under the load specified in Table 1, perform a non-
impact pull-out test. The two shall not loosen or separate.
6.10 Protection against Sharps Injury
When a product has the function of protection against sharps injury, the device shall comply
with the requirements of GB/T 42063.
7 Chemical Requirements
7.1 Preparation of Test Solution
Immerse 25 hypodermic needles, with their sheaths and / or sharps injury protection devices
removed, in 250 mL of freshly prepared Grade-3 water complying with the requirements of
GB/T 6682.Maintain the water constant at 37 °C 1 °C for 1 hour. Remove the hypodermic
needles and obtain the test solution. Simultaneously, use the same method described above to
prepare a blank control solution, without placing the hypodermic needles.
7.2 pH
When tested in accordance with the method specified in 5.4.1 of GB/T 14233.1-2022, the pH
difference between the test solution and the control solution from the same batch shall not
exceed 1.
7.3 Total Heavy Metal Content (metal ions)
When tested in accordance with the method specified in 5.9 of GB/T 14233.1-2022, the total
content of lead, tin, zinc and iron in the test solution shall not exceed 5 g/mL. The cadmium
content shall not exceed 0.1 g/mL.
When tested in accordance with the method specified in 5.6.1 of GB/T 14233.1-2022, the color
of the test solution shall not exceed that of a standard control solution with a mass concentration
of ρ(Pb2+) = 5 g/mL.
8 Biological Requirements
8.1 General Requirements
In accordance with the requirements of GB/T 16886.1, conduct biological evaluation of the
hypodermic needles. The evaluation results shall demonstrate the absence of biological hazards.
The basic requirements for biological evaluation of the hypodermic needles shall comply with
Appendix D.
8.2 Sterility
Each initially packaged hypodermic needles shall be sterilized using an appropriate method.
The sterilization process shall be validated and routinely controlled to ensure that the
probability of bacterial survival on the product is less than 106.Validation of the sterilization
process shall be documented.
NOTE. the sterility test method specified in GB/T 14233.3 is applicable to type test and not to exit-
factory inspection. Appropriate sterilization and exit-factory sterility inspection methods
are provided in GB 18279 or GB 18280.1.
8.3 Bacterial Endotoxins
When tested in accordance with the method described in GB/T 14233.3, the bacterial
endotoxins content shall be less than 20 EU/PCS.
9 Packaging
9.1 Initial Packaging
The hypodermic needles shall be enclosed in initial packaging. The material and design of the
initial packaging shall ensure that the color coding is visible.
When sterilized using ethylene oxide, the initial packaging of the hypodermic needles shall use
packaging material with a dialysis function or a full-dialysis function on one side. This
document encourages the use of packaging materials with better dialysis effect. The packaging
material shall not have a deleterious effect on the contents. The material and design of the
packaging shall ensure that.
a) under dry, clean and adequately ventilated storage conditions, the sterility of the
contents can be maintained;
b) when being removed from the packaging, the risk of contamination of the contents is
minimized;
c) during normal handling, transportation and storage, the initial packaging can
adequately protect the contents;
d) once opened, the packaging cannot be easily re-sealed and there are obvious traces of
being torn.
9.2 Medium Packaging
When sterilized using ethylene oxide, one or more initial packaging shall be put in medium
packaging with a dialysis function.
During normal handling, transportation and storage, the medium packaging shall be able to
adequately protect the contents.
9.3 Large Packaging
One or more medium packaging shall be put in large packaging.
During normal handling, transportation and storage, the large packaging shall be able to
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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