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GB 15811-2025 English PDF

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GB 15811-2025: Sterile hypodermic needles for single use
Status: Valid

GB 15811: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB 15811-2025	English	399	Add to Cart	4 days [Need to translate]	Sterile hypodermic needles for single use	Valid	GB 15811-2025
GB 15811-2016	English	135	Add to Cart	0--9 seconds. Auto-delivery	Sterile hypodermic needles for single use	Valid	GB 15811-2016
GB 15811-2001	English	599	Add to Cart	4 days [Need to translate]	Sterile hypodermic needles for single use	Obsolete	GB 15811-2001
GB 15811-1995	English	479	Add to Cart	4 days [Need to translate]	Sterile hypodermic needles for single use	Obsolete	GB 15811-1995

Basic data

Standard ID	GB 15811-2025 (GB15811-2025)
Description (Translated English)	Sterile hypodermic needles for single use
Sector / Industry	National Standard
Date of Implementation	2028-09-01
Older Standard (superseded by this standard)	GB 15811-2016

GB 15811-2016: Sterile hypodermic needles for single use

---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.
(One-time use of sterile needles) ICS 11.040.20 C31 National Standards of People's Republic of China Replacing GB 15811-2001 One-time use of sterile needles (ISO 7864.1993, NEQ) Issued on. 2016-06-14 2018-01-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 structure type and naming 1 4 marks Example 3 5 material 3 6 Physical Properties 3 Chemical properties 5 7 8 biological properties 6 9 Packaging 6 10 7 Flag 11 7 Inspection Rules 12 Storage 7 Appendix A (informative) flow test device 8 Annex B (informative) needled injection force test and evaluation methods 9 Annex C (normative) Biological Evaluation 11 Annex D (informative) Inspection Rules 12 References 13

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 15811-2001 "one-time use of sterile needles," Compared with GB 15811-2001, the main technical changes are as follows. --- Increased Chapter 5, "material"; --- Added Appendix A needle schematic flow test device; --- The needle puncture force requirements to Annex B (informative) gives the needle tip puncture force requirements and test methods; --- Remove the needle rigid 4.3.1, 4.3.2 and 4.3.3 syringe needle toughness corrosion Terms; --- Increasing the primary package should use paper and plastic packaging materials dialysis requirements; --- Revised Appendix D inspection rules. The standard reference method using redrafted ISO 7864.1993, "a one-time use of sterile hypodermic needle" preparation, and ISO 7864.1993 The non-equivalent. 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. Zhejiang Kindly Medical Devices Co., Ltd., Shanghai Medical Device detection. The main drafters. Zhang Honghui, Ding Biao. This standard replaces the standards previously issued as follows. --- GB 15811-1987, GB 15811-1995, GB 15811-2001. One-time use of sterile needles

1 Scope

This standard specifies the needle nominal diameter 0.3mm ~ 1.2mm to require a one-time use of sterile needles (hereinafter referred to as the needle) of. This standard specifies the needle is GB 15810 single-use sterile syringes supporting the use, but also for other appropriate to note Supporting the use of radio apparatus, as the human skin, subcutaneous, intramuscular, intravenous injection and other drug solution. This standard does not apply to single use dental needle. Non-sterile state for supporting the one-time use of sterile syringes disposable needle may refer to this standard.

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 1962.1-2015 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 1. General requirements Demand (ISO 594-1. 1986, IDT) GB/T 1962.2-2001 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock access Head (ISO 594-2.1998, IDT) GB/T 6682 analytical laboratory use specifications and test methods (GB/T 6682-2008, ISO 3696. 1987. MOD) GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods GB 15810 single-use sterile syringes (GB 15810-2001, eqvISO 7886-1.1993) GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and test (GB/T 16886.1- 2011, ISO 10993-1.2009, IDT) GB/T 18457-2015 manufacture of medical devices with a stainless steel needle (ISO 9626.1991, MOD) YY/T 0296 disposable needles color identification (YY/T 0296-2013, ISO 6009.1992, IDT) Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements (YY/T 0466.1-2009, ISO 15233-1.2007, IDT)

3 structure type and name

3.1 structure type shown in the needle, the name of each part of the terms and needle length L in Figure 1. Explanation. 1 --- needle seat; 2 --- connecting portion; 3 --- needle; 4 --- jacket; L --- needle length.

1 typical needle and sheath schematic diagram

3.2 the needle tip geometry shown in Figure 2 and naming. Explanation. d0 --- needle tube diameter; d1 --- needle tube diameter; A --- tip length; B0 --- first ramp nominal length; B1 --- right first ramp length; B2 --- left the first slope length; C0 --- second ramp nominal length; C1 --- right second ramp length; C2 --- left second slope length; α --- first bevel angle; φ --- second slope angle; β --- tip angle; θ1 --- right second bevel angle of rotation; θ2 --- left second bevel angle of rotation; γ --- combined with a second bevel angle. Figure 2 A typical tip geometry and naming

4 tag example

4.1 needle product labeling (specifications) needle tube nominal diameter, nominal length (Figure 1 L), the type of the wall and the first bevel angle (α) Composition, diameter and length of the unit to "mm", said the type of wall to RW (regular wall), TW (thin wall) or ETW (thin-walled), said first Bevel angle LB (long ramp angle) or SB (short bevel angle) represented. 4.2 comply with this standard syringe nominal outer diameter of 0.7mm, the length (L) of 30mm, thinner wall type, the first bevel angle Injection needle bevel angle mark length is. 0.7 × 30TWLB.

5 material

5.1 manufacture needle syringe should be consistent with GB/T 18457-2015 requirements of. Note. Each production batch should be rigid syringe, toughness and corrosion resistance information. 5.2 manufacturing hub material shall meet the requirements of Chapter 7, Chapter 8.

6 Physical Properties

6.1 Cleaning In 300lx ~ 700lx illuminance, with normal or corrected vision observe the needle tube surface, and by 2.5 magnification zoom bar without conditions Member observed hub surface should be clean and free of foreign matter. 6.2 color The needle should be needle holder and/or needle sheath color as indicated nominal diameter, should be consistent with YY/T 0296 requirements of. 6.3 Integrity Sight of the rest hub and needle tube connection should be honest, the needle should not have a significant skew. 6.4 Connecting fastness Needle holder and needle should be firmly connected to the injection needle tube fixed on a dedicated instrument to set aside the direction of the needle holder, under load specified in Table 1 Do not impact the pull-out test, the two can not be loose or separated. Table 1 pull-out test load forces Nominal outside diameter of the needle mm pull 0.3 22 22 0.33 22 0.36 0.4 22 22 0.45 0.5 22 34 0.55 Table 1 (continued) Nominal outside diameter of the needle mm pull 0.6 34 0.7 40 0.8 44 0.9 54 1.1 69 1.2 69 6.5 unimpeded Needle pinhole should be smooth. a) specified in Table 2 can pass freely through the needle; b) or not more than 100kPa pressure, the flow rate should be not less than the same outer diameter and length in line with GB/T 18457-2015 in Regulation 80% of the specified minimum inner diameter of the needle traffic. Appendix A provides a schematic flow test device. Table 2 millimeters in diameter through the needle Nominal outside diameter of the needle The diameter of the needle through 0-0.01 Normal thin-walled thin-walled wall 0.3 0.11 0.13 - 0.33 0.11 0.15 - 0.36 0.11 0.15 - 0.4 0.15 0.19 - 0.45 0.18 0.23 - 0.5 0.18 0.23 - 0.55 0.22 0.27 - 0.6 0.25 0.29 0.30 0.7 0.30 0.35 0.37 0.8 0.40 0.42 0.44 0.9 0.48 0.49 0.50 1.1 0.58 0.60 0.68 1.2 0.70 0.73 0.83 6.6 hub with sheath Injection needle holder and the sheath should be a good fit, the jacket can not fall off naturally, the needle holder is fixed on a dedicated instrument from the protective sleeve pull-out direction, For no impact drawing, two separate power should not exceed 15N. 6.7 tip Conditions under magnification of 2.5 times, with normal or corrected vision inspection should pinpoint sharp, no burrs and hooks and other defects. Note 1. The first tip bevel angle [alpha] (Figure 2) usually used (11 ± 2) °, known as long ramps; or the use of (17 ± 2) °, known as short bevel angle; Note 2. Appendix B shows the needle puncture force test and evaluation methods. 6.8 needle 6.8.1 needle surface lubricant, with normal or corrected to normal vision to observe the inner needle (tip portion) outer surface should not visible Lubricant accumulation. 6.8.2 inner needle should be clean, glycerin and alcohol evenly mixed 1, then with clean syringes to inject a mixture of 5mL by injection Shot needle. With normal or corrected to normal vision observation, the mixture flows through the tube wall of the needle should be no foreign matter and dirt. 6.8.3 Measuring with the general inspection, the outer diameter of the needle should be consistent with GB/T 18457-2015 provisions in Table 1. Needle tube length (Fig. 1 L) and Deviation should be in accordance with Table 3. Table 3 needle length and deviation in millimeters Needle tube nominal length L limit deviations L < 25 1-2 25≤L < 40 1.5-2.5 L = 40 0-4 L > 40 1.5-2.5 6.9 needle seat 6.9.1 observed with normal or corrected vision, the hub should be no burrs, such as injection molding of plastic flow and bubble defects. 6.9.2 The union conical needle seat shall comply with GB/T 1962.1-2015 requirements. GB/T 1962.1-2015 gives the conical fitting Standard Test Method for Performance. Needle seat for the locking tab type shall comply with GB/T 1962.2-2001 requirements. GB/T 1962.2-2001 gives Test methods for locking joint performance.

7 chemical properties

7.1 Preparation of test solution The 25 pulling the needle sheath immersed in 250mL made in line with the new GB/T 6682 stipulated level 3 water at 37 ℃ ± 1 ℃ Under constant temperature 1h, remove the needle to obtain test solution; the same time according to the same method of preparation and hold the needle blank solution. PH 7.2 When the test method according to GB/T 14233.1-2008 provisions, the difference between pH of test solution with the same batch control solution must not be greater than 1. 7.3 Total content of heavy metals (metal ions) When using atomic absorption spectrophotometry (AAS) or equivalent method of measurement, the total content of the test liquid barium, chromium, copper, lead and tin Shall not exceed 5μg/mL. Cadmium content should not exceed 0.1μg/mL. When the test method according to GB/T 14233.1-2008 specified in 5.6.1, the test liquid whose colors should not exceed a concentration of 5μg/mL The standard color control solution.

8 biological properties

8.1 Preparation of test solution The 25 pulling the needle sheath immersed in 250mL sterile, non-hot 0.9% sodium chloride solution in the original, at 37 ℃ ± 1 ℃ under constant temperature 1h, remove the needle to obtain fluid test, storage test solution should not exceed 2h. 8.2 Sterile Each package by the beginning of the injection needle should select the appropriate method of sterilization, the sterilization process to deal with validation and routine control to ensure that the production Bacterial survival probability product is less than 10-6. Confirm the sterilization process shall be documented. Note. GB/T 14233.2 specified in the sterility test method, which is suitable for the type test does not apply to factory inspection. Suitable sterilization and sterile factory Test methods see references in GB 18279 or GB 18280. 8.3 bacterial endotoxin Press GB/T 14233.2-2005 Test method, bacterial endotoxin content should be less than 20EU/support. 8.4 hemolysis Press GB/T 14233.2-2005 test method, the needle hemolysis rate should be less than 5%. 8.5 biocompatibility Shall GB/T 16886.1 requirements of the injection needle biological evaluation, the evaluation results should show no biological hazard. Appendix C to The basic requirements for a biological evaluation of the injection needle.

9 Packing

9.1 primary package Each needle should be encapsulated in a primary package. This packaging material and design should ensure that one of the visible color. When using ethylene oxide sterilization, syringes should be used early dialysis paper side of another sheet of dough or whole dialysis paper packaging materials, the standard drum Reed dialysis better packaging materials. Packaging material shall not adversely affect the contents. This packaging material and design should ensure that. a) in a dry, clean and well ventilated storage conditions, to ensure that the contents sterile; b) when removed from the packaging, the risk of contamination of the contents of the minimum; c) moving at normal, during transport and storage, on the primary package contents should be adequately protected; d) Once opened, the packaging can not be easily re-sealed, and should be obvious signs of being torn. 9.2 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. 9.3 Bulk More than one or in a package should be loaded into a large package. During normal handling, transport and storage, the packaging should be sufficient to protect the contents. 10 logo 10.1 General Glyph should comply with YY/T 0466.1 of. 10.2 primary package Should be the primary package at least the following flags. a) the product names and marks according to the requirements of Chapter 4; b) "sterile" or equivalent word mark; c) the lot number or the word "grant" LOT beginning; d) failure of years; e) "single use" or equivalent mark; f) the manufacturer and/or supplier name. 10.3 Packaging The packaging should have at least the following flags. a) the product names and marks according to the requirements of Chapter 4; b) the words or equivalent mark "sterile" and sterilization methods; c) "single use" or equivalent word mark; d) the lot number or the word "grant" LOT beginning; e) failure of years; f) the manufacturer and/or supplier's name and address. 10.4 Bulk If the package is loaded Bulk, shall have at least the following marks on Bulk. a) the product names and marks according to the requirements of Chapter 4; b) "sterile" or its logo; c) "single use" or equivalent word mark; d) the lot number or the word "grant" LOT beginning; e) failure of years; f) handling, storage and transport requirements; g) the manufacturer and/or supplier's name and address. 10.5 transport packaging materials If you do not use large packaging, but the packaging is packaged together for transport and 10.4 required content should be marked on the transport packaging material, or We should be able to see the content requirements of 10.4 through the packaging material. 11 inspection rules Appendix D gives the finished product type test (cycle test) testing rules. 12 Storage Sterilized needles should be stored in a non-corrosive gases and ventilated room, and the injection needle have adequate protection.

Appendix A

(Informative) Flow test device Figure A.1 shows a schematic flow test device, any other equivalent method. Explanation. 1 --- a check valve of the inflatable ball; 2 --- blood pressure table; 3 --- liquid line; 4 --- switch; 5 --- 6% taper joints; 6 --- weighing container. Figure A.1 schematic flow test device

Appendix B

(Informative) An injection needle through force test and evaluation methods B.1 Principle Puncture force test device with the injection needle at a predetermined speed, vertical assessed injected through the skin analog maximum peak force measured Needle piercing power. B.2 Test equipment and materials B.2.1 Test apparatus Shown in Figure B.1 other devices can also be used with the same performance and accuracy. Explanation. 1 --- transmission unit with a pressure measuring device; 2 --- test needle; 3 --- simulation skin; 4 --- simulation skin fixture; 5 --- measuring amplifier; 6 --- data processing and display unit; 7 --- printer; 8 --- memory. Figure B.1 Typical test apparatus for measuring and recording piercing force Technical indicators B.2.2 Test B.2.2.1 linear drive speed. 50mm/min ~ 250mm/min, average speed accuracy ≤ ± 5% (setting). B.2.2.2 pressure sensor measuring range. 0 ~ 50 (0 ~ 5) N, the accuracy of ± 0.5% (full scale). B.2.3 simulate skin material B.2.3.1 Material. polyurethane film. B.2.3.2 Thickness. 0.35mm ± 0.05mm. B.2.3.3 Hardness. Shore A (85 ± 10). B.2.3.4 exposed area after clamping .() equal to φ10mm. B.3 Test procedure B.3.1 The test pin and analog skin for at least 24h at 22 ℃ ± 2 ℃, and tested at the same temperature. B.3.2 Press measuring apparatus shown in Fig. B.1, the appropriate size simulation skin (B.2.3) clip in the fixture, without any significant stretching or Compressive force is applied to the simulation of the skin. B.3.3 The test needle mounted on the testing device (B.2.1), its axis is perpendicular to the simulated skin (B.2.3) surface, the tip pointing circular puncture area Center field. B.3.4 The test device (B.2.1 The) is set to the moving speed of 100mm/min. B.3.5 start testing device. B.3.6 puncture the membrane process, while the measured maximum peak force or record force/displacement map. NOTE. Do not use a circular needle puncture region has done a film. B.4 puncture force Recommended injection needle through the force are shown in Table B.1. Table B.1 Recommended needle puncture force specification mm Puncture force 0.3 ~ 0.6 ≤0.70 0.7 ~ 0.9 ≤0.85 1.1 ~ 1.2 ≤1.15

Appendix C

(Normative) Biological Evaluation When new products into production, materials and production processes have significant changes, should be GB/T 16886.1 of materials and/or end-product raw Substance evaluation, basic evaluation test as follows. a) cytotoxicity; b) sensitization; c) stimulation; d) hemolysis; e) acute systemic toxicity.

Appendix D

(Informative) Inspection rules The finished project-based standard type inspection Chapter 6 to Chapter 8, 9.1,10.1 the requirements. Chapters 6 and 9.1,10.1 requirements were randomly selected five, should be fully qualified. If there is a failure, the other pump 10 reinspection shall be full Ministry qualified. twenty one references [1] GB 15810-2001 disposable sterile syringes [2] GB 18671-2002 disposable intravenous infusion needle [3] GB 18281.2-2000 Sterilization of health care products - Biological indicators - Part 2; ethylene oxide sterilization Biological indicators [4] GB 18278-2000 Sterilization of health care products industry validation and routine control of sterilization warm [5] GB 18279-2000 ethylene oxide sterilization of medical devices - Validation and routine control [6] GB 18280-2000 Sterilization of health care products Requirements for validation and routine control of radiation sterilization [7] GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals [8] ISO 8537.1991 with or without the one-time use of sterile insulin syringe needle

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