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Translation - English 3.1 Needle Unit
A main sheath, a needle and a neilsbed (see picture 1)
3.2 Rigid Package
A needle unit consisting of a rigid sheath of butt joints and a rigid sheath for the puncture end forms a obturating and integrited unit. (see picture 1) 0
3.3 Flexible Package
A needle unit includes a ready-made plastic tray with a tearing cover, in which there is a dentistry needle puncture end protected by a rigid sheath.
Note: The needle sheath of butt joints is dispensable.
3.4 Main Needle Sheath
The protective package for the needle: rigid package or flexible package
3.5 Auxiliary Sheath
The auxiliary Sheath contains the main one.
4 Product Marks
The mark of the dental needle is denoted by the type of the neilsbed, the outside diameter and the length of the needle tube and the angle of the bezel. The type of the neilsbed is signified by whorl neilsbeds L, G (metric internal whorl neilsbed) and W (Wyeth internal whorl neilsbed). The outside diameter and the length of the needle tube take "mm" as the unit. The type of the needlepoint bevel is indicated by LB (long bevel angle) or SB (short bevel angle).
Example: 0.4 mmX40mm
Note: The neilsbed type and the needlepoint bevel angle of the can be marked on the package
5 Material
The material for the manufature of the dentistry needle tube should be consistent with the provisions of GB18457.
6. Physical Requirements
6.1 Color Code
The color of the nominal outside diameter of the needle should be the same with that of the neilsbed and/or the sheath (sheath for the puncture end or for the butt joints). And the color should meet the requirements of YY/T0296.
6.2 Firmness of Connection
When 22 N axial tension force at the rate of 1 mm / s is imposed on the joint of the dentistry needle tube and the neilsbed, the two parts shall not disconnect or become flexible.
6.3 The Smoothness of the Needle-hole Flow
The smoothness of the inner needle-hole flow should be one of the followings:
A corresponding probe selected in table 1 can get through freely,
OR,
Under the pressure not greater than 100kPa, the flow rate should not be less than that of a needle tube of the smallest inside diameter with the same outside diameter and length consistent with the provisions of GB18457 and, under the same pressure, the tested flow rate shall not be less than 80.
A schematic diagram of a flow testing installation is given in Appendix B.
Translation - Chinese 6.4 No Visible Foreign Bodies on the Surface
6.4.1 The surface of the assembled dental needle tube and the needle collar should be free from the foreign bodies under the observation of normal vision or corrected vision(without magnifier),
6.4.2 If coated with lubricant, there shouldn’t be any lubricant gathering on the outside surface under the observation of normal vision or corrected vision.
6.5 Needle Tube
6.5.1 Length
The deviation of the nominal length（puncture end length I）of the needle tube should be士2mm.
6.5.2 Length of Butt Joints End
The length of butt joints end (see L in picture I) should be between 9.0mm-14mm.
6.5.3 Outside Diameter of the Needle Tube
Should be between 0.25mm-0.5mm and in accordance with the specifications of GB18457-2001
6.5.4 Property of the Tube
The rigidity, tenacity and inoxidability of the tube should meet the requirements of GB18457
6.6 Needlepoint
Under the inspection of a 2.5X magnifier, the needlepoint should be sharp and without burr, raw edges, hook, blunt end and/or other defects.
Note: Angle of the dental needlepoint: the first chamfered angle of the puncture end usually adopt 18°±3°(SB) or 12°士3°(LB) while the butt joint needlepoint angle adopt 15°~55°.
6.7 Needle Collar
6.7.1 General
The needle collar can be with or without a screw thread
6.7.2 Needle Collar with Screw Thread
Should have inner screw thread;
Should closely coordinate with barrel type dental injector which agree with ISO9997:1990
Note: the connector thread under ISO9997:2000 is metric M6X0.75, if to adopt British system, please consult appendix F.
6.7.3 Needle Collar without Screw Thread
Should be stably poinched on the barrel type dental injector corresponding with ISO9997:1990.
6.7.4 Depth of the Needle Collar
The depth of the needle collar(L in picture 1) should be no less than 5mm.
7 Chemical Requirements
7.1 Test Fluid
Prepare test fluid for chemical test according to the requirements of appendix B。
7.2 pH value
Following the test method 5.4.1 in GB/T14233.1-1998, the difference of the pH value between the test fluid for the dental needle and for contrast should be no more than 1.
Translation - Chinese 7.3 Extractable Metal Contents
Following the test method 5.6.1 in GB/T14233.1-1998, the extractable metal contents of the test fluid for dental needle should be no more than 5pg/mL.
Following the test method 5.9.1 in GB/T14233.1-1998, the contents of cadmium in the dental needle should be less than 0.15pg/mL.
8 Biological Requirements
8.1 General
The dental needle should not release any substance that can cause side effects to the patient. The toxicity should be evaluated by fitting tests. The instructions for the toxicity test is provided in Appendix E.
8.2 Sterile
The dental needle in the initial packaging (single packaging) should go through a confirmed sterilizing procedure to sterilize the dental needle. Sterile test method is provided in GB/T14233.2.
8.3 Bacterial Endotoxins
Prepare the test fluid according to Appendix C.
Following the bacterial endotoxins test method provided in GB/T14233.2，the endotoxin in the collector should be less than 0.5EU/mL.
9 Packaging
9.1 Initial packaging (single packaging)
Every piece of dental needle should have a main protecting casing, either rigid or soft material. The material and the design of the main protecting casing should guarantee that:
1) The maintanance of the sterile conditions;
2) The identification of the color code;
3) If was opened, traces should be found obviously;
4) Sheath for punture end can act as a bracket, when connected to the injector, it should avoid the operator from touching the needle.
9.2 Middle Packaging
One or more initial packaging should be loaded into a middle packaging. In regular carrying, transporation and storage, the middle packaging should protect the contents efficiently.
9.3 Outer Packaging
One or more middle packaging should be loaded into an outer packaging. In regular carrying, transporation and storage, the outer packaging should protect the contents efficiently.
10 Marks and Instructions
10 1 The following information should be on the initial packaging or middle packaging
a) The name, specifications,type of the puncture end of the dental needle;
b) The names or trademarks of the producer/dealer;
c) graphic symbol under YY0466, to signify the sterility of the dental needle;
d) single use only or equivalent explanation;
Note: “Single Use” graphic symbol in YY0466 can be adopted.
e) Warning sign for the inspection of the completeness of the packaging ahead of usage.
Translation - English Note: At least, there should be information of a), b), c), d), g), and h) on the initial packaging of rigid butt joint.
10.3 Instructions:
The serial number and verbalization should be in line with the provisions of relative regulations.
a) Article name and specification;
b) Name, address, zip code and phone number of the producer;
c) The product registration number and product carries out standard number;
d) The version number and publication date of the instruction;
e) The features, applications and conditions of usage;
f) The main structure, functions, applications and sphere of applications;
g) Instructions, precautions and sphere of contraindication;
h) Methods of sterilization, explanations of period of validity;
i) Interpratation of the tags, graphic marks, symbols and compilations;
j) Requirements for transportation, storage and maintenance;
k) Promise of the producer and other particulars needed explanation to the users.
11 Storage
Well-packed products should be stored in clean ventilative rooms without corrosive gaseous body.
Appendix B Preparation of test fluid for dissolved matter test
Choose 25 pieces of dental needle, remove the protective sheath, put it into the glass vessel, fill in water to 250ml. Keep it for 2 hours under constant temperature of 37℃士1℃.Gather together all the fluid and take as the test fluid. Fill in a glss vessel the same volume of water without the dental needle, do the same thing and take the fluid as a contrast.
The water used for the test should meet the standard of third class water of GB/T6682
Choose 25 pieces of dental needle. remove the protective sheath and, together with the needle tube, put into the sodium chloride solution which should be 250mL, sterile, pyrogen-free and the contents of sodium chloride should be 9g/L.
Keep it for 1 hours under constant temperature of 37℃士1℃. Take out the dental needle,including the tube and obtain the test fluid.
Note:The storage of the test fluid should be no longer than 2 hours.
Chinese to English: On Dental Needle
Source text - Chinese D.1 周期检查(型式试验)
D.1.1在下列情况下应进行型式试验:
a)新产品投产，材料来源或配方改变时;
b)结构，关键零配件，工艺有重大改变时;
c)连续生产中每年不少于二次;
d)停产整顿恢复时;
e) 合同规定或管理部门的要求;
f) 质量监督部门对产品质量进行监督抽查时
D.1.2型式检验为全性能检验。
D.1.3周期检查应按GB/T2829的规定进行。
D.1.4抽样方法:从出厂检验合格批中随机抽取，样品抽取数量按表D.1的规定。周期检查采用一次抽样方案，其不合格品分类，试验组，检查项目，判别水平，RQL(不合格质量水平)按表D.1的规定。
D.2 出厂检验 (逐批检查)(推荐)
D.2.1出厂检查按GB/T2828的规定逐批进行检验，合格后方可出厂。
D.2.2 以同种牙科针产量组成生产批
D.2.3 抽样方案采用一次抽样，抽样方案的严格度从正常抽样方案开始，其不合格品分类、检查项目,检查水平(IL)和合格质量水平(AQL)按表D.2的规定。
附 录 E 生物学评价
当新产品投产、材料和生产工艺有重大改变时，应按GB/T16886.1对材料和/或最终产品进行生物学评价，基本评价内容为:
a) 急性全身毒性;
b) 热原
附 录 F 英制螺纹规格
本标准仅规定了公制规格的牙科注射针的要求。然而，英制牙科注射针的存在形式应该引起注意，
目前正在生产英制螺纹规格的牙科注射针的制造商必须转换为公制螺纹，国际标准提示2005年为英制转公制的目标日期
本标准提及带螺纹针座的英制螺纹规格，为了患者安全的利益，英制螺纹规格应当为;0.218英寸(5.54mm)40TPI(螺纹数/英寸)惠氏螺纹牙样。
Translation - English D.1 Periodic Examination(Type Test)
D.1.1 Type test should be taken under the following conditions:
a) New product brought into production, alteration of material source or ormulation;
b) Major changes of the structure, key elements or technics;
c) No less than twice a year in processive production;
d) Resumption after cessation and regulation;
e) Regulations of the contract or requests of the administration section;
f) When the quality supervision departments are doing their duty;
D.1.2 The type examination should be full functional examination
D.1.3 The periodic examination should follow the provisions of GB/T2829
D.1.4 Sampling approach: to draw samples randomly from the qualified ones by exfactory inspection. The quantity should follow the stipulations of Table D.1. The periodic examination should adopt a same sampling plan. The classification of rejectable ones, experimental group, inspections, determining level
RQL(Rejectable Quality Level) should follow the stipulations of Table D.1
D.2 Exfactory Inspection(lot-by-lot inspection)(Recommended)
D.2.1 The exfactory inspection should follow GB/T2828 and take lot-by-lot inspection. Qulified ones can leave the factory.
D.2.2 Form the production lot by the same kind of dental needle.
D.2.3 The sampling plan should adopt single sampling. The strictness of the sampling method starts from the normal sampling method. The classification of rejectable ones, experimental group, inspections, determining level
RQL(Rejectable Quality Level) should follow the stipulations of Table D.2
Appendix E Biological Evaluation
When new products are brought into production, material or technics go through major alteration, the material and/or finial products should be evaluated biologically under the provisions of GB/T16886. 1. The basic contents are:
a) Toxicity
b) Pyrogen
Appendix F Screw Thread of British System
This standard just regulates the requirements for the dental injection needle of metric system. The existing mode of dental injection needle under british system should draw our attention.
The present producers should transform into metric system. International Standard points out that the target date of the transformation from British to metric is 2005.
This standard refers to the needle collar with screw thread of British system, for the interest of the patients, the specifications should be 0.218 inches(5.54mm)40TPI(No. of screw thread/inch) Whitworth form of thread
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