This standard specifies the product classification, technical requirements, test methods, inspection rules and requirements for marking, packaging, transportation and storage of acupuncture needles. This standard applies to non-sterile acupuncture needles and disposable sterile acupuncture needles for acupuncture therapy. GB 2024-1994 Acupuncture Needles GB2024-1994 Standard Download Decompression Password: www.bzxz.net

National Standard of the People's Republic of China
Acupuncture needles
Acupunclure needles
1 Subject content and scope of application
GB 2024-94
Replaces G 2024-87
This standard specifies the product classification, technical requirements, test methods, inspection rules and marking, packaging, transportation and storage requirements of acupuncture needles. This standard applies to sterilized acupuncture needles and disposable sterile acupuncture needles (hereinafter referred to as sterile acupuncture needles) for acupuncture therapy. 2 Reference standards
GB191 Packaging, storage and transportation pictorial marks
GB/T2828 Batch inspection, counting, drawing, sampling procedures and sampling tables (applicable to continuous batch inspection)GB/T4240 Stainless steel wire
GB/T4342 Metal micro-Vickers hardness test methodGB/T4506 Needle tip sharpness and strength test method3 Product classification
3.1 Acupuncture needles are divided into sterilized acupuncture needles (disposable non-shaded acupuncture needles) and fire-resistant bacteria acupuncture needles (acupuncture needles). 3.2 The needle handle types of acupuncture needles are divided into flat handle needles, ring handle needles, and flower handle needles. 3.3 The types of sterilized acupuncture needles are divided into two types: with needle tube and without needle tube. 3.4 The specifications of acupuncture needles are expressed as the diameter of the needle body × the length of the needle body. 3.5 The types of acupuncture needles are shown in the figure below, and their basic dimensions should comply with the provisions of Table 1. Approved by the State Administration of Technical Supervision on April 12, 1994 178
Implemented on October 1, 1994
GB2024-94
Flat handle needle
Ring handle needle
Huaqi needle
Tongding insert
Huoyin needle Hot needle (with needle tube)
Types of acupuncture needles
Note: The types shown in the figure only illustrate several typical structural types. The needle handle type and the fixing method of the needle tube of the flat handle needle are not unified Yao Ding KAONrKAca=
Product specificationswww.bzxz.net
0. 18×13
0.30×100
Basic size
Limit deviation
GB 2024—94
Basic size
Limit deviation
Basic size
52(50)
75(65)
52(50)
75(65)
85(80)
52(50)
75( 65)
85(80)
110(105)
52(50)
75(65)
85(80)
110(105)
150(140)
Limit deviation
±1,75
Wire diameter of handle
Product specifications
0. 35 × 75
0. 35×100
C, 40×100
0,45×40
0.45×100
Basic dimensions
Limit deviation
Note: ①The dimensions in brackets are the total length of the flat handle needle. ② The roundness of the needle body diameter should not be greater than 0.005 αm. ③ Special types and specifications are subject to ordering regulations. 4 Technical requirements
GB2024—94
Continued Table 1
Basic dimensions
Limit deviation
Basic dimensions
52(50)
75(65)
85(80)
110(105)
150(140)
52(50)
75(6 5)
85(80)
110(115)
150(140)
75（65)
85(80)
110(105)
150(140)
Limit Deviation
4.1 Acupuncture needles shall comply with the requirements of this standard and be manufactured in accordance with the drawings and technical documents approved by the prescribed procedures. 4.2 The basic dimensions of acupuncture needles shall comply with the provisions of Article 3.5. 4.3 The body of acupuncture needles shall be made of 0C℃119Ni9 or other aspheric stainless steel wire specified in GB/T4240. Note: The material of the needle handle is not uniformly specified. If plastic is used, it must be medical non-toxic plastic. 4.4 The hardness of the body of acupuncture needles shall comply with the provisions of Table 2. Table 2
Hardness HVo.2 kg
0. 16,0.18,0. 20,0. 25,0, 30C.35,0,40.0.45
Sterile acupuncture needle
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Porcelain wire diameter
mSterile moxibustion needle
GB 2024—94
4.5 The tip of the acupuncture needle should be round and straight, without burrs, hooks and other defects. After the specified force and hardness contact and top pressure, the puncture force should not be greater than that specified in Table 3.
0.16,n.18.0.20.0.25
0. 30,0.35
0.40,0.45
Item pressure N
4.6 The needle body should have good toughness. After the winding test, there should be no cracks, breaks or delamination. 4.7
The surface of the needle body should be smooth, and its appearance quality and surface roughness parameter R should comply with the requirements of Table 4. Table
Product reputation
Appearance quality
Milted acupuncture needles
Shall not have obvious defects such as injuries, bends and silk patterns 0.63
Puncture force.
Unfired acupuncture needles
Shall not have injuries, bends and pitting
The connection between the needle body and the needle handle should be firm. Carry out a pull test under the force value specified in Table 5. The axial displacement of the two shall not be greater than 3mm. 4.8
0.16,0.18
0.20,0.25
03. 30,0. 35
0.40.0.25
Sterile acupuncture needle
Tensile force N
Non-sterile needle
4.9 If the handle of acupuncture needle is made of winding wire, its spiral coils should be arranged evenly without obvious distance. 4.10 The handle of acupuncture needle shall not have burrs. Acupuncture needle shall be straight and shall not have obvious bending. 4. 11
4.12 The surface color of the handle of acupuncture needle shall be uniform. If the handle is silver-plated, the coating shall be silvery white and shall not have delamination. 4.13 The needle body shall have good corrosion resistance. 4. 14
Sterile acupuncture needle shall be sterile.
Test method
5.1 Appearance
Observe visually.
Note: the test in Article 4.5 shall be carried out with a 10x magnifying glass. 5.2 Surface roughness: Compare with the surface roughness standard. 5.3 Dimensions
Measured with a general or special measuring tool.
5.4 Performance
5.4.1 Hardness test
GB 2024—94
Performed in accordance with the requirements of GB/T4342 standard and shall comply with the provisions of Article 4.4. 5.4.2 Needle sharpness test
Performed in accordance with the requirements of GB/T4506 standard and shall comply with the provisions of Article 4.5. 5.4.3 Needle body toughness test
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Wrap the needle body in a tight spiral along the spiral line on a core row with a diameter of 3 times the diameter of the needle body. Wrap the needle body with a length of 13mm twice, and wrap other lengths t times. It should comply with the provisions of Article 4.6. 5.4.4 Needle body and needle handle connection-solidity test First measure the length of the needle body, then fix the needle body in the fixture, and perform a non-impact pull test on the end face of the needle handle along the needle body axis according to the force specified in Article 4.8, and then measure the length of the needle body. It should comply with the provisions of Article 4.8. 5.4.5 Needle handle burr test
Touching the handle of the acupuncture needle with your hand should not feel burrs. 5.4.6 Anti-corrosion test of needle body
Remove oil stains from the needle body, immerse it in 10-degree citric acid solution at room temperature for 5 hours, take it out, boil it in distilled water for 30 minutes, cool it at room temperature and keep it for 48 hours, then take it out and let it evaporate naturally in the air or blow it dry with hot air. Visually observe the surface of the needle body, and there should be no rust.
5.4.7 Sterility test
Randomly select 40 samples from each batch of sterilization products and randomly divide them into two groups, with 20 samples in each group, and conduct the test. The sterility test shall be carried out in accordance with the sterility test method in the appendix of the 1990 edition of the Pharmacopoeia of the People's Republic of China: it shall comply with the provisions of Article 4.14. 6 Inspection rules
6.1 Acupuncture needles shall be inspected by the technical inspection department of the manufacturer and can only be submitted for acceptance after they are qualified. 6.2 Acupuncture needles must be submitted for inspection in batches, and the inspection shall be batch-by-batch inspection (factory inspection). 6.3 Batch-by-batch inspection shall be carried out in accordance with the provisions of GB/T2828. 6.4 The sampling plan adopts a sub-sampling, and the strictness of the sampling plan starts from the normal inspection sampling plan: the classification of unqualified products, the items, the inspection level and the qualified quality level (AQI.) shall be in accordance with the provisions of Table 6. Table 6
General classification
Unqualified product classification group
Inspection items
Inspection level
Qualified quality level
All qualified
Note: The sterilization batch of sterilized acupuncture needles shall be provided with a sterility test report. 4.4
6.5 Acupuncture needles: The batch size of a batch submitted for inspection shall not exceed 150,000. 7 Marking, packaging, transportation, storage
(Sharpness of needle tip)
7.1 The unit packaging container of sterilized acupuncture needles should have good sealing. Packaging: After opening, the container should not be easily re-sealed, and it can be clearly seen that the container has been opened.
7.2 The small package should have the following marks:
Manufacturer name or trademark;
b. Product name,
Type, specification.
GB 2024—94
7.3 Acupuncture needles of the same specification should be packed into a medium packaging carton, and the inspection certificate should be kept in the box. The box should have the following marks:
Manufacturer name and trademark:
Product name;
Type, specification and quantity;
This standard push number.
The following marks shall be added to the packaging box of fire fungus acupuncture needles: 7.3.1
Small packages are damaged and cannot be used;
Sterilization date;
Expiration date of sterilization.
The following marks shall be on the inspection certificate:
Manufacturer name:
Inspector code;
Inspection date.
The box shall be sealed. The seal shall have the packer code. 7.4 The same standard acupuncture needles shall be packed in large corrugated boxes. 7. 4. 1
The following marks should be on the carton:
Manufacturer name and address;
Product name,
Model, specification, quantity;
Manufacture date and factory batch number;
Gross weight;
Volume (length × width × height);
Standard number;
“Handle with care”, “Don’t be afraid of heat” and other words or marks. It should comply with GB 191. The words or marks on the box should be guaranteed not to be blurred after a long time. 7.4.2 The following marks shall be added to the sterilized acupuncture needle packaging carton: a.
Sterilization date (instead of manufacturing month);
Sterilization method:
Sterilization validity period.
7.4.3. The carton should be affixed with a seal, and the seal should have the packer's code. 7.5 The packaging quantity and special packaging requirements shall be in accordance with the order contract. 7.6 Transportation requirements shall be in accordance with the order contract.
7.7 Acupuncture needles should be stored in a room with a relative humidity not exceeding 80%, no corrosive gases, good ventilation and cleanliness. 8 Others
8.1 Packaged acupuncture needles should be guaranteed not to rust within two years from the date of leaving the factory under the condition of complying with the storage rules. 8.2 Sterilized acupuncture needles, under the condition of complying with the storage rules, have a sterilization validity period of two years from the date of sterilization. 484
Additional notes:
This standard was proposed by the State Drug Administration. GB 2024-94
This standard is under the jurisdiction of the Technical Management Unit for Medical Device Standardization of the State Drug Administration. This standard was drafted by Suzhou Medical Supplies. The main drafter of this standard is Li Qingyang.
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