GB 2024-2016 English PDFUS$419.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 2024-2016: Acupuncture needles Status: Valid GB 2024: Historical versions
Basic dataStandard 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11.040.99 Word Count Estimation: 21,261 Date of Issue: 6/14/2016 Date of Implementation: 2018-07-01 Older Standard (superseded by this standard): GB 2024-1994 Quoted Standard: GB/T 191; GB/T 2828.1-2012; GB/T 2829-2002; GB/T 4340.1; GB/T 6682; GB/T 9969; GB/T 14233.2; GB 18278.1; YY/T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 ForewordAll 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.IntroductionThis 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 needles1 ScopeThis 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 referencesThe 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 × 40mm4 Requirements4.1 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 methods5.1 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 Package6.1 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 RulesAppendix D gives the finished product batch test (factory inspection) and in the form of inspection (periodic inspection) inspection rules.9 transport and storage9.1 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 0.0......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 2024-2016_English be delivered?Answer: Upon your order, we will start to translate GB 2024-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB 2024-2016_English with my colleagues?Answer: Yes. The purchased PDF of GB 2024-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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