GB 15811-2025 (GB 15811-2016) PDF English
US$135.00 · In stock · Download in 9 secondsGB 15811-2016: Sterile hypodermic needles for single use Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid GB 15811: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 15811-2025 | English | 399 |
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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
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| GB 15811-2001 | English | 599 |
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Sterile hypodermic needles for single use
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| GB 15811-1995 | English | 479 |
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Sterile hypodermic needles for single use
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GB 15811-2016: 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/GB15811-2016
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.
3.2 Syringe needle tip geometry and naming are as shown in Figure 2.
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
5 Materials
5.1 Tubes for the manufacture of injection needles shall meet the
requirements of GB/T 18457-2015.
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
6.5 Smoothness
The pinhole of syringe needle shall be smooth.
6.6 Coordination between needle seat and jacket
The needle seat and jacket of syringe needle shall coordinate well. The jacket
shall not fall off naturally. Fix the needle seat on the special instrument. Pull
out the direction from the protective case. Perform the impact-free pull off test.
The separation between the two shall not exceed 15 N.
6.7 Needle tip
Under 2.5 times magnification, with normal or corrected vision, observe the
needle tip that shall be sharp, no flash, burr or hook or other defects.
6.8 Needle tube
6.8.1 When needle tube surface uses lubricants, use normal or corrected
vision to observe. There shall be no visible build-up of lubricant on the inner
and outer surface of the needle tube (tip part).
6.8.2 Needle tube shall be clean. Mix glycerin and alcohol by 1.1 evenly.
Then use a clean syringe to inject 5 mL of the mixture through the syringe
needle.
6.9 Needle seat
6.9.1 Use normal or corrected vision to observe and needle seat shall have
no significant flash, burr, plastic flow or bubble injection defects.
6.9.2 The needle seat is conical joint type that shall comply with the
requirements of GB/T 1962.1-2015.GB/T 1962.1-2015 gives the test method
of the performance of conical joint.
7 Chemical properties
7.1 Preparation of testing solution
Immerse 25 syringe needles with jacket pulled off into 250 mL of new
prepared Grade 3 water specified in GB/T 6682.
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.
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.
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
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.
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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