GB 2024-2016 (GB 2024-1994) PDF English
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GB 2024-1994: Acupuncture needles---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/GB2024-1994
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
Replacing GB 2024-87
Acupuncture needles
针灸针
Issued on: APRIL 12, 1994
Implemented on: OCTOBER 01, 1994
Issued by. State Bureau of Technical Supervision
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Product categories... 4
4 Technical requirements... 7
5 Test methods... 9
6 Inspection rules... 11
7 Marking, packaging, transport, storage... 11
8 Others... 13
Acupuncture needles
1 Scope
This standard specifies the product classification, technical requirements, test
methods, inspection rules and marking, packaging, transport and storage
requirements of acupuncture needles.
This standard applies to unsterilized acupuncture needles and disposable
acupuncture needles for acupuncture therapy (hereinafter referred to as sterile
acupuncture needles).
2 Normative references
GB 191 Packaging - Pictorial marking for handling of goods
GB/T 2828 Sampling procedures and tables for lot-by-lot inspection by
attributes (Apply to inspection of successive lots or batches)
GB/T 4240 Stainless steel wires
GB/T 4342 Metallic materials - Vickers microhardness test
GB/T 4506 Method for the test of sharpness and strength of needles tips
3 Product categories
3.1 The acupuncture needles are divided into two types. sterile acupuncture
needles (disposable sterile acupuncture needles) and unsterilized acupuncture
needles (acupuncture needles).
3.2 The handle type of acupuncture needle is divided into flat-handle needle,
ring-handle needle, flower-handle needle.
3.3 The sterile acupuncture needle is divided into two types. with needle-
inserting tube, without needle-inserting tube.
3.4 The specifications of the acupuncture needle are expressed by the diameter
of the needle x the length of the needle.
3.5 The type of acupuncture needle is as shown in the Figure below. The basic
size shall meet the requirements of Table 1.
the provisions of clause 4.4.
5.4.2 Sharpness test of needle’s tip
It is performed according to the requirements of GB/T 4506.It shall comply with
the provisions of clause 4.5.
5.4.3 Toughness test of needle’s body
Wind the needle’s body in a tight spiral around the mandrel having a diameter
of 3 times the diameter of the needle’s body along the spiral direction. If the
length of the needle’s body is 13 mm, wind the needle for two circles; for the
needle’s body of other lengths, wind it for five circles. The results shall comply
with the provisions of clause 4.6.
5.4.4 Test of the connection firmness between the needle’s body and the
needle’s handle
First measure the length of the needle’s body, then fix the needle’s body in the
clamp. On the end face of the needle’s handle, use the force as specified in
clause 4.8 to perform shockless pulling test along the axial direction of the
needle’s body, then measure the length of the needle’s body. The results shall
meet the requirements of clause 4.8.
5.4.5 Test of needle handle’s burr
Use hands to touch the handle of the acupuncture needle, it shall not have the
sense of burrs.
5.4.6 Test of corrosion resistance of needle’s body
Remove the oil from the needle’s body. Immerse it in 10% citric acid solution
for 5 h at room temperature. Take it out. Place it in steaming water to boil it for
30 min. Cool it at room temperature for 48 h. Then remove it and let it evaporate
naturally in the air; or use hot air to dry it. Visually observe the surface of the
needle’s body. It shall be free from rusting.
5.4.7 Sterility test
From each batch of sterile products, randomly take 40 samples. Randomly
divide them into two groups, each group contains 20 samples. Perform parallel
test.
The sterility test shall be carried out in accordance with the sterility test method
in the Appendix of the 1990 version of the Pharmacopoeia of the People's
Republic of China. The results shall comply with the provisions of clause 4.14.
c. Type, specifications.
7.3 Acupuncture needles of the same specification shall be packed in a
medium-sized carton. The inspection certificate shall be placed in the carton.
The carton shall have the following markings.
a. Manufacturer’s name and trademark;
b. Product name;
c. Type, specification, quantity;
d. This standard number.
7.3.1 The medium-sized packaging box for the sterile acupuncture needles
shall also have the following markings.
a. It is prohibited to use if the small package is damaged;
b. Date of sterilization;
c. Effective period of sterilization.
7.3.2 The inspection certificate shall have the following markings.
a. Manufacturer’s name;
b. Inspector’s code;
c. Date of inspection.
7.3.3 There shall be a seal on the box, there shall be a packer’s code on the
seal.
7.4 Acupuncture needles of the same specifications are packed into large-sized
corrugated boxes.
7.4.1 The carton shall have the following markings.
a. Manufacturer’s name and address;
b. Product name;
c. Model, specification, quantity;
d. Date of manufacture and exit-factory batch number;
e. Gross weight;
f. Volume (length x width x height);
g. This standard number;
h. Words or signs such as “Handle with care”, “Avoid heat”, which shall
comply with the provisions of GB 191.
The words or signs on the carton shall be guaranteed not to be obscured after
long-time.
7.4.2 The large-sized packing carton for sterile acupuncture needles shall also
has the following markings.
a. Date of sterilization (instead of date of manufacture);
b. Method of sterilization;
c. Effective period of sterilization.
7.4.3 The carton shall be affixed with a seal, on which there shall be the packer’s
code.
7.5 Packaging quantity and the packaging with special needs are as specified
in the order contract.
7.6 Transport requirements are as specified in the order contract.
7.7 Acupuncture needles shall be stored in a corrosive-gas-free, well-ventilated,
clean room with a relative humidity of not more than 80%.
8 Others
8.1 After the packaging, the acupuncture needles shall be rust-free within two
years from the date of exit-factory, subject to the provisions of storage.
8.2 Sterile acupuncture needles shall, subject to the provisions of storage, have
a sterilization period of two years from the date of sterilization.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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