GB 15811-2016 English PDF (GB15811-2016)

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GB 15811-2016: Sterile hypodermic needles for single use
GB 15811-2016
GB
NATIONAL STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing GB 15811-2001
Sterile hypodermic needles for single use
(ISO 7864.1993, NEQ)
ISSUED ON. JUNE 14, 2016
IMPLEMENTED ON. JANUARY 1, 2018
Issued by. General Administration of Quality Supervision, Inspection
and Quarantine;
Standardization Administration Committee.
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 
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.
- GB 15811-1987. GB 15811-1995, GB 15811-2001.
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
GB 15810, Sterile hypodermic syringes for single use (GB 15810-2001,eqv
ISO 7886-1.1993)
GB/T 16886.1, Biological evaluation of medical devices - Part 1. Evaluation
and testing within a risk management process (GB/T 16886.1-2011, ISO
10993-1.2009, IDT)
GB/T 18457-2015, Stainless steel needle tubing for the manufacture of
medical devices (ISO 9626.1991, MOD)
YY/T 0296, Hypodermic needles for single use - Colour coding for
identification (YY/T 0296-2013, ISO 6009.1992, IDT)
YY/T 0466.1, Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1. General
requirements (YY/T 0466.1-2009, ISO 15233-1.2007, IDT)
3 Structural type and naming
3.1 The structure of syringe needle, the terms of each part and needle tube
length L are shown in Figure 1.
keys.
1 - needle seat;
2 - link;
3 - needle tube;
4 - jacket;
L - needle tube length.
Figure 1 -- Typical needle and sheath schematic
3.2 Syringe needle tip geometry and naming are as shown in Figure 2.
keys.
d0 - needle tube outer diameter;
d1 - needle tube inner diameter;
A - needle tip length;
B0 - first bevel nominal length;
B1 - first right bevel length;
B2 - first left bevel length;
C0 - nominal length of the second bevel;
C1 - right second slope length;
C2 - left second slope length;
α - first bevel angle;
Φ - second bevel angle;
β - tip angle;
θ1 - right second bevel rotation angle;
θ2 - left second bevel rotation angle;
γ - joint second bevel angle.
Figure 2 -- Typical tip geometry and naming
4 Marking example
4.1 The mark (specification) of the syringe needle product is composed of
the nominal outer diameter of the needle tube, 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 "mm", the tube wall type in RW (normal wall), TW
(thin wall) or ETW (extra thin wall), the first bevel angle in LB (long bevel
angle) or SB (short bevel angle).
4.2 The syringe needle that complies with this Standard of which the
nominal outer diameter of needle tube is 0.7 mm, the length (L) is 30 mm, the
tube wall type is thin wall, the first bevel angle is a long bevel angle shall be
Syringe needle rotates at an
angle of Φ
The view shows the difference
when the first bevel crosses the tip
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.