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一次性使用无菌注射针
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GB 15811-2016
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标准编号: GB 15811-2016 (GB15811-2016)
中文名称: 一次性使用无菌注射针
英文名称: Sterile hypodermic needles for single use
行业: 国家标准
中标分类: C31
国际标准分类: 11.040.20
字数估计: 17,157
发布日期: 2016-06-14
实施日期: 2018-01-01
旧标准 (被替代): GB 15811-2001
引用标准: GB/T 1962.1-2015; GB/T 1962.2-2001; GB/T 6682; GB/T 14233.1-2008; GB/T 14233.2-2005; GB 15810; GB/T 16886.1; GB/T 18457-2015; YY/T 0296; YY/T 0466.1
采用标准: ISO 7864-1993, NEQ
起草单位: 浙江康德莱医疗器械股份有限公司
归口单位: 全国医用注射器(针)标准化技术委员会
标准依据: 国家标准公告2016年第8号
范围: 本标准规定了针管公称外径为0.3mm～1.2mm的一次性使用无菌注射针(以下简称注射针)的要求。本标准规定的注射针是与GB 15810一次性使用无菌注射器配套使用, 也适合于其他相适宜的注射器具配套使用, 作为对人体皮内、皮下、肌肉、静脉等注射药液用。本标准不适用于一次性使用牙科注射针。非灭菌状态供一次性使用无菌注射器配套的一次性使用注射针可参照本标准。
GB 15811-2016: 一次性使用无菌注射针
GB 15811-2016 英文名称: Sterile hypodermic needles for single use
1 范围
本标准规定了针管公称外径为0.3mm~1.2mm的一次性使用无菌注射针(以下简称注射针)的要求。
本标准规定的注射针是与GB 15810一次性使用无菌注射器配套使用,也适合于其他相适宜的注
射器具配套使用,作为对人体皮内、皮下、肌肉、静脉等注射药液用。
本标准不适用于一次性使用牙科注射针。
非灭菌状态供一次性使用无菌注射器配套的一次性使用注射针可参照本标准。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB/T 1962.1-2015 注射器、注射针和其他医疗器械 6%(鲁尔)圆锥接头 第1部分:通用要
求(ISO 594-1:1986,IDT)
GB/T 1962.2-2001 注射器、注射针和其他医疗器械 6%(鲁尔)圆锥接头 第2部分:锁定接
头(ISO 594-2:1998,IDT)
GB/T 6682 分析实验室用水规格和试验方法(GB/T 6682-2008,ISO 3696:1987:MOD)
GB/T 14233.1-2008 医用输液、输血、注射器具检验方法 第1部分:化学分析方法
GB/T 14233.2-2005 医用输液、输血、注射器具检验方法 第2部分:生物学试验方法
GB 15810 一次性使用无菌注射器(GB 15810-2001,eqvISO 7886-1:1993)
GB/T 16886.1 医疗器械生物学评价 第1部分:风险管理过程中的评价与试验(GB/T 16886.1-
2011,ISO 10993-1:2009,IDT)
GB/T 18457-2015 制造医疗器械用不锈钢针管(ISO 9626:1991,MOD)
YY/T 0296 一次性使用注射针 识别色标(YY/T 0296-2013,ISO 6009:1992,IDT)
YY/T 0466.1 医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分:通用要求
(YY/T 0466.1-2009,ISO 15233-1:2007,IDT)
3 结构型式与命名
3.1 注射针的结构型式,各部分的名称术语和针管长度L 如图1所示。
3.2 注射针针尖的几何图形及命名如图2所示。
4 标记示例
4.1 注射针产品的标记(规格)以针管公称外径、公称长度(图1中的L)、管壁类型和第一斜面角度(α)
组成,外径和长度单位以“mm”表示,管壁类型以RW(正常壁)、TW(薄壁)或ETW(超薄壁)表示,第一
斜面角度以LB(长斜面角)或SB(短斜面角)表示。
4.2 符合本标准要求的针管公称外径为0.7mm,长度(L)为30mm,管壁类型为薄壁,第一斜面角度
为长斜面角的注射针标记为:0.7×30TWLB。
5 材料
5.1 制造注射针的针管应符合GB/T 18457-2015的要求。
注:针管的每一生产批应有刚性、韧性和耐腐蚀性信息。
5.2 制造针座的材料应满足第7章、第8章的要求。
6 物理性能
6.1 清洁
在300lx~700lx照度下,用正常或矫正视力在不经放大条件下观察针管表面,和经2.5倍放大条
件下观察针座表面应清洁,无异物。
6.2 色标
注射针应以针座和/或护套的颜色作为针管公称外径的标示,应符合YY/T 0296的要求。
6.3 正直
目力观察针座与针管连接应正直,针管不应有明显的歪斜。
6.4 连接牢固度
针座与针管连接应牢固,将注射针针管固定在专用仪器上,以针座拨出方向,在表1规定的载荷下
做无冲击的拉拔试验,两者不得松动或分离。
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).
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
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)
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
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.
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;
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;
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
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
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,
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
direction and carry out the impact-free pull-off test under the load specified in
Table 1. Both must not be loose or separated.
Table 1 -- Load of pull-off test
Table 1 (continued)
6.5 Smoothness
The pinhole of syringe needle shall be smooth.
a) the tip cleaner specified in Table 2 shall be able to pass through freely;
b) or under a water pressure not greater than 100 kPa, the flow shall not be
less than 80% of minimum inner diameter syringe flo...
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