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GB 2024-2016: Acupuncture needles
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PDF similar to GB 2024-2016
Basic data | Standard ID | GB 2024-2016 (GB2024-2016) | | Description (Translated English) | Acupuncture needles | | Sector / Industry | National Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 21,261 | | Date of Issue | 6/14/2016 | | Date of Implementation | 2018-07-01 | | Older Standard (superseded by this standard) | GB 2024-1994 | | Quoted Standard | GB/T 191; GB/T 2828.1-2012; GB/T 2829-2002; GB/T 4340.1; GB/T 6682; GB/T 9969; GB/T 14233.2; GB 18278.1; YY/T 0466.1; GB 18279.1; GB/T 18279.2; GB 18280.1; GB 18280.2; GB/T 18280.3 | | Regulation (derived from) | National Standard Announcement No. 8 of 2016 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This standard specifies the classification, requirements, test methods, inspection rules, packaging, marking, instruction manual, transportation and storage of acupuncture needles. This standard applies to acupuncture needles for acupuncture therapy. | GB 2024-2016: Acupuncture needles---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Acupuncture needles)
ICS 11.040.99
C31
National Standards of People's Republic of China
Replacing GB 2024-1994
Acupuncture needles
Issued on. 2016-06-14
2018-07-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
All the technical contents of this standard is mandatory.
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces GB 2024-1994 "acupuncture needle", and GB 2024-1994 compared to the main technical changes are as follows.
--- Increased with plastic handle and metal tube handle type of acupuncture needle;
--- Modify the hardness requirement specifies the upper limit of the hardness of the needle;
--- Modify the requirements acupuncture needle handle length, only the provisions of the minimum length requirements;
--- Increasing the needle body surface should not visible aggregation lubricant requirements;
--- Increased packaging requirements;
--- Added Appendix A material guide;
--- Added Appendix D inspection rules.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical syringe (needle) Standardization Technical Committee (SAC/TC95) centralized.
This standard was drafted. Medical supplies factory in Suzhou Co., Ltd.
The main drafters of this standard. Cao Yang, Xu Aimin, Jiang heart then.
This standard replaces the standards previously issued as follows.
--- GB 2024-1980, GB 209-1983, GB 2024-1987, GB 2024-1994.
Introduction
This standard for professional acupuncturist acupuncture needles used in acupuncture.
Acupuncture needles used clinically before use disinfection of non-sterile acupuncture needles, and the factory sterilized, can be dismantled
Open primary package directly disposable two sterile acupuncture needles.
To avoid stifling innovation, this standard is not limited to a combination of acupuncture needle diameter and length. But taking into account the clinical needs, requirements of the standard are still
Given package product specifications (pin diameter and length of the needle) on the product packaging and labeling.
Acupuncture needle tip sharpness and puncture resistance has very important clinical significance of this Appendix B of this standard gives strength and frontal tip
Lee index test method.
Because each manufacturer's design, production process and sterilization methods are different, so the choice of the manufacturer does not provide acupuncture needle handle material
Material, needle and needle handle material should have good biocompatibility. GB/T 16886.1 provided corresponding to the biological evaluation of medical devices and
Test, recommended that manufacturers consider the contents of this standard in the assessment of the product, to ensure the safety of the product in order to facilitate and promote the improvement of product quality.
At the same time, manufacturers should be within the product's entire life cycle, and national and regional regulatory requirements related to medical devices historical data, clinical
Practice, the use of risk analysis techniques, risk management products, to ensure the safety and efficacy of the product. YY/T 0316 provides
The manufacturer of medical devices and the use of risk-related framework for effective management.
Acupuncture needles
1 Scope
This standard specifies the classification of acupuncture needles, requirements, test methods, inspection rules, packaging, signs, instructions, transport and storage.
This standard applies to acupuncture needles for acupuncture use.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB/T 2828.1-2012 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch test sample
plan
GB/T 2829-2002 periodic inspection Sampling procedures and tables (suitable for process stability test)
GB/T 4340.1 metallic materials - Vickers hardness test - Part 1. Test methods
Laboratory use specifications and test methods GB/T 6682 Analysis
GB/T 9969 General Instructions industrial products
GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods
GB 18278.1 heat sterilization of health care products - Part 1. Development of medical equipment sterilization process, validation and routine control
Claim
Ethylene oxide sterilization GB 18279 (all parts), health care products
GB 18280 (all parts) Radiation Sterilization of health care products
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
Category 3
The typical structure of acupuncture needles and 3.1 Part Names should meet the requirements of Figure 1.
Figure 1 Schematic diagram of a typical acupuncture needles
Varieties 3.2 acupuncture needles into non-sterile acupuncture needles (acupuncture needles) and disposable sterile acupuncture needles (sterile acupuncture needles) two.
3.3 acupuncture needle into the needle handle type ring shank needles, flat handle needles, stalks needle, plastic handle needles, needles and other metal pipe handle, as shown in FIG.
a) ring shank pin
b) needle flat shank
c) stalk needle
d) plastic handle needle
e) metal tube handle needle
Explanation.
d --- needle diameter;
D --- needle shank diameter;
l1 --- needle length;
l2 --- needle handle length.
Note. the type shown in the figure, shows the typical structure of several types.
Figure 2 acupuncture needles needle shank type
3.4 disposable sterile acupuncture needles into the type into the syringe into the tube and not two kinds of needles, acupuncture needle into the needle tube of the type shown in Figure 3
FIG.
Note. The needle tube fixation without uniform regulations.
Figure 3 disposable sterile acupuncture needles (needle into the tube) of the type
3.5 Specifications of acupuncture needles needle body diameter × length of the needle body.
Example. φ0.30mm × 40mm
4 Requirements
4.1 Basic dimensions
4.1.1 needle diameter should be in accordance with Table 1.
Table 1 needle diameter basic dimensions in millimeters
Nominal pin diameter d tolerance
0.12≤d < 0.25 ± 0.008
0.25≤d < 0.50 ± 0.015
0.50≤d≤0.80 ± 0.020
4.1.2 needle body length should be in accordance with Table 2.
Table 2 needle length basic dimensions in millimeters
Nominal needle length tolerance l1
5 \u003cl1≤25 ±0.5
25 \u003cl1≤75 ±1.0
75 \u003cl1≤100 ±1.5
100 \u003cl1≤200 ±2.0
4.1.3 acupuncture needles needle shank length l2 shall not be less than 18mm.
4.1.4 wire around the handle should meet the requirements of Table 3; plastic handle, metal pipes and other shank diameter should be in accordance with Table 4.
Table 3 around the shank diameter of the wire in millimeters
The nominal diameter d around the needle shank diameter of the wire
0.12≤d < 0.20 0.30
0.20≤d < 0.30 0.35
0.30≤d < 0.40 0.40
0.40≤d < 0.50 0.45
0.50≤d≤0.80 0.50
Diameter in Table 4 plastic handle, handle as the metal pipe mm
Needle handle type pin shank diameter D
Metal pipe handle, plastic handles, etc. 0.80 to 2.50
4.2 Hardness
Acupuncture needles needles hardness shall conform to Table 5.
Table 5 pin hardness
Nominal pin diameter d
mm
hardness
0.12≤d < 0.25 480HV0.2 ~ 650HV0.2
0.25≤d≤0.45 460HV0.2 ~ 650HV0.2
0.45 \u003cd≤0.80 420HV0.2~530HV0.2
4.3 Performance tip
Acupuncture needle tip portion shall not round the positive side, no glitches, hooks and other defects, applying a predetermined force is in contact with the top pressure steel block, its puncture force should
Not more than specified in Table 6.
Table 6 pressure and piercing
Nominal pin diameter d
mm
Top pressure
Piercing
0.12≤d≤0.25 0.4 0.7
0.25 \u003cd≤0.35 0.5 0.8
0.35 \u003cd≤0.45 0.6 0.9
0.45 \u003cd≤0.80 0.7 1.0
4.4 needle toughness
The needle should have good toughness, there should be no cracks after winding test, breaking and delamination.
4.5 surface quality
Needle body surface should be smooth, clean and free of impurities in the metal processing; surface appearance quality and surface roughness parameters Ra value should meet
Co specified in Table 7.
Table 7 appearance quality and value Ra
Product variety disposable sterile acupuncture needles are not sterilized acupuncture needles
Appearance quality no obvious scars, marks and curved wire pattern defects may not have scars, marks the music, pitting
Ra value ≤0.63μm ≤0.4μm
4.6 needle and needle handle connections fastness
Connection needle and the needle should be firmly handle the force specified in Table 8 in value mainly as tension test, both the axial displacement is not greater than 3mm.
Table 8 Tensile test values
Nominal pin diameter d
mm
pull
0.12≤d≤0.18 8
0.18 \u003cd≤0.25 10
0.25 \u003cd≤0.35 15
0.35 \u003cd≤0.45 20
0.45 \u003cd≤0.55 25
0.55 \u003cd≤0.80 30
4.7 helical coil arrangement
Needle handle acupuncture needles, such as the use of winding wire, which should be uniformly arranged spiral ring.
4.8 needle handle
Acupuncture needle shank can not have glitches.
4.9 flat
Acupuncture needles should be straight.
4.10 color
Acupuncture needle shank surface color should be uniform. Shank such as the use of the coating can not have from the floor, off phenomenon.
4.11 Lubricant
Needle surface is coated with a lubricant such as needle body surface should not visible lubricant convergence.
4.12 needle corrosion resistance
The needle should have good corrosion resistance.
4.13 sterile
Disposable sterile acupuncture needles should have been confirmed by a sterilization process for sterilization, ensure sterility of the product.
Note. Suitable sterilization methods see references, GB 18278.1, GB 18279, GB 18280 provides confirmation of medical equipment sterilization process and routine control of
Claim.
4.14 biocompatibility
Acupuncture needles should be given in Annex A guide to select suitable materials, and evaluation of biocompatibility.
5 Test methods
5.1 Basic dimensions
Gaging with general or special.
5.2 Hardness
According to GB/T 4340.1 Test methods.
5.3 Performance tip
5.3.1 tip Appearance
10 times magnifying glass to check, needle appearance should meet the requirements of 4.3.
5.3.2 tip sharpness and strength tests
Appendix B performed according to the method of tip sharpness and strength tests.
5.4 needle toughness
The needle body is wound around a tight spiral turns, along a helical direction in a diameter of 3 times the diameter of the mandrel pin, is not larger than the length of the needle
15mm 2 laps winding, other lengths wound 5 turns.
5.5 surface quality
With 10 times the magnifying glass and inspect the surface roughness comparison specimen test.
5.6 needle and needle handle connections fastness
Measure the length of the needle, and the needle body is fixed in the fixture, the axial end surface of the needle along the needle handle slowly added masterpiece no impact tensile test
Test to force a predetermined value of 4.6, and then measure the length of its needles.
5.7 helical coil arrangement
Observed with normal or corrected vision.
5.8 needle handle
Touch acupuncture needle shank should be feeling glitches.
5.9 flat
Observed with normal or corrected vision.
5.10 color
Observed with normal or corrected vision.
5.11 Lubricant
Observed with normal or corrected vision.
5.12 needle corrosion resistance
According to the requirements of Appendix C test.
5.13 sterile
Sterility test method GB/T 14233.2 specified conduct.
Note. This method is not suitable for factory inspection.
6 Package
6.1 primary package
6.1.1 Acupuncture needles should be the primary package.
6.1.2 There should be within the disposable sterile acupuncture needles primary package visible foreign matter. Packaging material shall not harmful contents
The impact of this packing material and design should ensure that.
a) in a dry, clean and well ventilated storage conditions, to ensure that the contents were maintained sterility in the period;
b) when removed from the package, the contents of the risk of contamination by the minimum;
c) In a normal move, during transport and storage of the contents adequate protection;
d) Once opened, the package can not be easily re-sealed, and should be obvious signs of being torn.
Note. GB/T 19633 provides requirements for the final medical device packaging materials and systems, manufacturers sit at a sterile acupuncture needle packaging design, evaluation confirmed
Taking into account the contents of this standard.
6.2 Packaging
More than one or one of the primary package should be loaded in a package.
During normal handling, transport and storage, the contents of the package should be fully protected.
6.3 packaging
More than one or in a package should be loaded in a packaging.
During normal handling, transport and storage, packaging should be sufficient to protect the contents.
7 signs, instructions
7.1 marks
Packaging labels, signs and symbols provide information shall comply with YY/T 0466.1 of.
7.2 single packages or units packed primary package
7.2.1 shall be marked with at least the beginning of the packaging or packaging unit.
a) manufacturer's name or trademark and;
b) the product name;
c) specification;
d) the number (for unit packaging);
e) the production date or production lot.
7.2.2 First use of sterile disposable acupuncture needles should have the following logos on the packaging.
a) sterilization, "sterile" and other words and/or symbols;
b) "single use" the words and/or symbols;
c) sterilization expiration date.
7.3 Packaging
7.3.1 package should have inspection certificate and operating instructions. At least the following marks on the packaging.
a) manufacturer's name, address and trademark;
b) the product name;
c) the type, size and number;
d) the production date or production lot;
e) license number according to regulatory requirements;
f) If the needle surface with a coating (such as lubricants), and should indicate the name or the coating composition;
g) warnings, such as. electro-acupuncture therapy acupuncture needle body might cause corrosion.
7.3.2 The use of sterile disposable acupuncture needles in the package must also add the following flags.
a) sterilization, "sterile" and other words and/or symbols;
b) "single use" the words and/or symbols;
c) sterilization expiration date;
Warning words before use to check the integrity of the primary package d) "packaging damaged prohibit the use of" and "destroyed after use", etc., unless the warning says
Ming has been given in the primary package.
7.4 packaging
7.4.1 If the same type, size of acupuncture needles in the outer package is loaded, the packaging should have at least the following flags.
a) manufacturer's name and address;
b) the product name;
c) the type, size and number;
d) the production date or production lot;
e) mass (gross mass, net mass);
f) the volume (length × width × height);
g) license number according to regulatory requirements;
h) "afraid of the rain" and other words or signs, should be consistent with GB/T 191 provisions. Words or logo on the packaging in order not to be last
Longer obscured.
7.4.2 disposable acupuncture needles sterile packaging must also add the following flags.
a) sterilization, "sterile" and other words and/or symbols;
b) "single use" the words and/or symbols;
c) the date of sterilization or sterilization lot number;
d) sterilization expiration date.
7.5 User's Guide
Instructions for the preparation shall comply with GB/T 9969's.
8 Inspection Rules
Appendix D gives the finished product batch test (factory inspection) and in the form of inspection (periodic inspection) inspection rules.
9 transport and storage
9.1 Transport
Acupuncture needles on the transport should be to prevent stress, sunlight and rain and snow Baptist leaching.
9.2 Storage
Packaged acupuncture needles should be stored at room temperature, relative humidity less than 80%, non-corrosive gases, well-ventilated and clean room.
Appendix A
(Informative)
Guide material
A.1 materials used in the manufacture of acupuncture needles should adapt its sterilization process.
A.2 material for the manufacture of acupuncture needles in the course of routine use of, shall not adversely affect the physical or chemical.
A.3 materials used in the manufacture of acupuncture needle body shall comply with 06Crl9Nil0 or other austenitic stainless steel wire GB/T 4240 stipulated.
A.4 acupuncture needle body when the material used is changed, the needle surface increase the coating (lubricant) or there are signs that the product used in a human hair
Adverse reactions caused by aquatic organisms security should be increased in accordance with the provisions of GB/T 16886.1 of the material and the final product biology Review
Price (no such case can be exempted), basic evaluation test as follows.
a) cytotoxicity;
b) sensitization;
c) stimulation.
Appendix B
(Normative)
Acupuncture needle tip sharpness and strength tests
B.1 definitions
Acupuncture needle tip strength. Acupuncture needle tip perpendicular load force acting on the steel block, the hook of the force does not appear.
Acupuncture needle tip sharpness. Acupuncture needle tip perpendicular to the force required to pierce the foil.
B.2 acupuncture needles and sharp tip strength tester technical requirements
B.2.1 acupuncture needles and sharp tip strength tester shown in Figure B.1, other devices can also be used with the same performance and accuracy (including
Mounted on the apparatus for measuring amplifiers, data processing and display units, printers and floppy disks and other devices).
B.2.2 full load of equipment, the minimum speed indication and should meet the requirements of Table B.1.
Explanation.
1 --- Power switch;
2-4 --- Job control switch;
5 --- aluminum fixture;
6 --- needle clamp;
7 --- adjusting pendulum;
8 --- Level.
Figure B.1 acupuncture needle sharp tip tester
Table B.1 instrument full load, the minimum value and the speed shown
Flag Project
Full load of 1.2N
Minimum indication 0.01N
Speed ≤10mm/s
B.2.3 instrument indication error should be less than 0.01N.
B.2.4 instrument calibration should be level and anti-shock device, the needle holder holding acupuncture needle sites should be able to adjust, stable and should be used.
B.2.5 instrument gearing should be sensitive and reliable.
Starting inductance B.2.6 instrument should be less than 0.02N.
B.2.7 instrument foil clamp aperture φ5mm, aluminum foil sandwiched after not loose, aluminum foil inside the aperture should be flat.
B.3 steel test block
Test acupuncture needle tip strength steel block surface should be smooth, no rust.
B.4 acupuncture needle tip sharpness tests with aluminum foil technical requirements
B.4.1 foil surface should be clean, smooth, non-overlapping or severe wrinkles, mildew and dense rows of trachoma.
B.4.2 soft material of aluminum foil to a thickness of 0.05mm ± 0.002mm, purity of not less than 99.5%.
B.4.3 tensile strength of the aluminum foil is not less than 3kg/mm2, elongation of not less than 3%.
B.5 Test Method
B.5.1 tip strength test
The sample holder acupuncture needles in needle clamp (acupuncture needle tip is exposed needle clamp 5mm or more), acting on the tip vertical steel block, press B.2.2
Speed prescribed load to a predetermined force value 4.3, holding 5s ~ 10s after removal of the load. The sample was then acupuncture needle 5x magnifying glass
Observation, the tip may not have a hook or drag on cotton with a needle without the fibers.
B.5.2 tip sharpness test
B.5.2.1 appropriate size aluminum foil sandwiched between aluminum foil jig, without any significant tensile or compressive force applied to the aluminum foil.
B.5.2.2 The sample after acupuncture needle holding strength test in the needle clamp, press the control switch, so that the measured transmission by acupuncture needles hanging
Straight gradually augmented on an aluminum foil, corresponding rotation of the pendulum, when used as a tip force exceeds the strength of aluminum foil, aluminum foil needle piercing that is, the instrument automatically stops
Only afterburner, this time value (or value displayed on the instrument) is the point of a needle piercing force measured acupuncture needle swing lever indicated by the pointer.
B.5.2.3 job control switch button is pressed, the instrument of the pendulum and pointer (display instrument indication) reset.
B.5.2.4 relax aluminum fixture, moving the fixture inside the foil, so that the spacing between puncture hole is larger than the diameter of the sample to be tested more than 3 times.
B.5.2.5 B.5.2.1 ~ B.5.2.4 Repeat the above steps, and measured three times, and the arithmetic mean of the measured value is the sharpness of acupuncture needles
Puncture force.
B.5.3 Schematic
Tip sharpness and strength test principle of the method shown in Figure B.2.
Figure B.2 tip sharpness and strength test method schematic
twenty one
Appendix C
(Normative)
Corrosion test methods --- citric acid test method
C.1 Lab
Glass beaker.
C.2 Reagents
Citric acid (chemically pure).
C.3 citric acid solution preparation
In line with GB/T 6682 regulations formulated tertiary water 100g/L citric acid solution.
C.4 Specimen preparation
Austenitic stainless steel acupuncture needle body or the manufac...
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