GB 18671-2009 PDF EnglishUS$85.00 · In stock · Download in 9 seconds
GB 18671-2009: Intravenous needles for single use Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB 18671: Historical versions
Similar standardsGB 18671-2009: Intravenous needles for single use---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/GB18671-2009GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.20 C 31 Replacing GB 18671-2002 Intravenous needles for single use Issued on. MAY 6, 2009 Implemented on. MARCH 1, 2010 Issued by. General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration Committee. Table of ContentsForeword... 3 Introduction... 5 1 Scope... 6 2 Normative references... 6 3 Structure and naming... 7 4 Examples of marking... 8 5 Materials... 8 6 Physical requirements... 8 7 Chemical requirements... 11 8 Biological requirements... 11 9 Marks... 12 10 Packaging... 14 Annex A... 15 Annex B... 17 Annex C... 18 Annex D... 19 References... 24ForewordAll technical content of this Standard is mandatory. This Standard replaces GB 18671-2002 “Intravenous infusion needles for single use.” The main differences between this Standard and GB 18671-2002 are as follows. - the applicable scope was expanded to infusion needles for. gravity feed- type infusion sets, infusion sets used with pressure infusion equipment, and transfusion sets; the corresponding requirements were added; - added infusion needle with 0.36 mm needle tube specification and corresponding requirements; - changed product mark to specification mark; - made connection base requirements mandatory; - re-categorized the requirement relating to inner diameter for quick evaluation of needle tube openness to flow; it is now a requirement in informational Annex form for further evaluation of needle tube and needle tip quality; eliminated the qualitative needle tip puncture force test methods; - changed pH test to titrimetric method; - eliminated the ethylene oxide residue quantity requirement for infusion needles sterilized with ethylene oxide; added a requirement that packaging make use of dialytic materials; - revised mark and packaging requirements; - eliminated the exit-factory inspection. Annex A and Annex B of this Standard are normative. Annex C and Annex D are informative. This Standard was proposed by China State Food and Drug Administration. This Standard shall be under the jurisdiction of China National Technical Committee on Standardization of Medical Infusion Devices. Drafting organizations of this Standard. Zhejiang Kangdelai Medical Apparatus Stock Co., Ltd., Jinan Quality Supervision and Inspection Centre for Medical Devices of China State Food and Drug Administration. Main drafters of this Standard. Zhang Honghui, Song Jinzi, Wu Ping, Jia Fei. This Standard replaces the following previous version. - GB 18671-2002.IntroductionThere are two main forms in which intravenous infusion needles are supplied. One is supplied to hospitals together with infusion and transfusion sets.; the other is supplied to hospitals as independent commercial products. The first one accounts for the great majority of such needles in China. The sterility, packaging, and labelling requirements of this Standard do not apply to intravenous infusion needles supplied together with infusion and transfusion sets. To meet different clinical needs, this Standard does not limit combinations of needle tube outer diameter and length. However, in view of the need to provide identification for product sales and clinical use, this Standard requires labelling of needle tube length, tube wall type, and needle tip type in addition to labelling of needle tube outer diameter. As a transitional measure, GB 18671-2002 classified the G/T 1962 requirement on inner conical fittings as a suggested requirement. Seeing as many enterprises have gradually adopted semi-rigid 6% inner conical fittings, this version has reclassified the requirement as mandatory. Intravenous needles for single use1 ScopeThis Standard specifies requirements for single-use intravenous infusion needles (hereinafter referred to as “infusion needles”) of which the nominal outer diameter is 0.36 mm ~ 1.2 mm to ensure adaptability to gravity feed-type infusion sets, infusion sets used with pressure infusion equipment, and transfusion sets. This Standard provides a guide to the properties and quality norms for the materials used in infusion needles. Clause 3 to 8.1, and 8.3 of Clause 8 of this Standard give quality norms for infusion needles supplied with infusion and transfusion sets.2 Normative referencesThe following standards contain the provisions which, through reference in this Standard, constitute the provisions of this Standard. For dated references, subsequent amendments (excluding corrections) or revisions do not apply to this Standard. However, the parties who enter into agreement based on this Standard are encouraged to investigate whether the latest versions of these documents are applicable. For undated reference documents, the latest versions apply to this Standard. GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment - Part 1.General requirements (GB/T 1962.1- 2001, idt ISO 594-1.1986) GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment - Part 2.Lock fittings (GB/T 1962.2-2001, idt ISO 594-2.1998) GB/T 6682 Water for analytical laboratory use-Specifications and test methods (GB/T 6682-1992, idt ISO 3696.1987) GB 8368-2005 Infusion sets for single use - Gravity feed (ISO 8536-4.2004 MOD)3 Structure and namingFigure 1 shows the structure, names of parts, and needle tube length (L) of a typical infusion needle.4 Examples of marking4.1 Infusion needle specification mark is presented in terms of needle tube nominal diameter, nominal length, tube wall type, and angle (α) of first bevel of needle tip. The outer diameter and length are expressed in “mm”. 4.2 For an infusion needle that is compliant with This Standard, that has a needle tube nominal outer diameter of 0.7 mm, a nominal length (L) of 30 mm, and a tube wall type of thin wall, and that has a needle tip first bevel angle that is a long bevel angle, the specification mark is.5 MaterialsThe needle tubing used to manufacture infusion needles shall comply with the requirements of GB 18457.6 Physical requirements6.1 Color labelling The color of the needle handle and/or sheath of an infusion needle shall be used to label the nominal outer diameter of the needle tube. The color shall comply with the requirements of YY/T 0296. 6.3 Firmness of connections 6.3.1 When subject to 20 N axial static pulling force for 10 continuous seconds, the connection between the infusion needle handle and the needle tube shall not break or become loose. 6.4 Leakage The inner cavity of the infusion needle shall have a good seal. It shall not leak when tested in accordance with Clause A.2. Infusion needles used together with infusions sets used with pressure infusion equipment shall comply with the requirements in 6.3 of YY0286.4-2006. 6.5 Flow When tested in accordance with Clause A.3, the outflow of water under 20 kPa pressure shall be no lower than what is specified in Table 1. 6.6 Length of needle tube When the nominal length of the needle tube is less than or equal to 15 mm, the needle tube length (L in Figure 1) shall be the nominal value ± 1.0 mm. When the nominal length is greater than 15 mm, the needle tube length shall be the nominal value +1.5 mm/-2.0 mm. 6.8 Lubricant If a needle tube is coated with a lubricant, examine the needle with normal or corrected vision. There shall be no visible lubricant accumulations on the outer surface of the needle tube. 6.9 Connecting base The conical fitting of the connecting base shall comply with the requirements of GB/T 1962.1 or GB/T 1962.2. The connecting base of an infusion needle used in an infusion set used with pressure infusion equipment shall employ a lock fitting. 6.11 Flexible tube The flexible tube of the infusion needle shall be soft, transparent, bright and clean, and free of obvious mechanical impurities, foreign matter, and kinks. It shall be transparent enough to allow observation of bubbles and drawn blood.7 Chemical requirements7.1 Reducing substances When testing in accordance with Clause B.2, the difference between volumes of potassium permanganate solution [c(KMnO4) = 0.002 mol/L] consumed by the test solution and by the blank solutions shall not exceed 2.0 mL. 7.2 Metal ions When conducting an assay according to the atomic absorption spectroscopy (AAS) in B.3.1 or according to an equivalent method, the total barium, chromium, copper, lead, and cadmium content in the test liquid shall not exceed 1 μg/mL. The cadmium content shall not exceed 0.1 μg/mL. 7.3 pH When tested according to Clause B.4, the amount of the standard solution needed to change the indicator color grey shall in no case exceed 1 mL. 7.4 Evaporation residue When tested according to Clause B.5, the total amount of evaporation residue shall not exceed 2 mg.8 Biological requirements8.1 Biocompatibility The infusion needle shall not release any substance that would cause a side effect in the patient. GB/T 16886.1 presents a guide for biocompatibility evaluations and tests. The results of evaluations and tests shall indicate that the infusion needle is non-toxic. 8.2 Sterility Infusion needles in primary packaging shall undergo confirmed sterilization processes to make the product sterile. 8.3 Bacterial endotoxins When testing according to GB/T 14233.2, draw 5 mL of extracting medium into a syringe and connect it to an infusion needle. After injecting until the inner cavity of the infusion needle is full, seal the head end of the needle.9 Marks9.1 Primary package The primary package shall have at least the following information. 9.2 Intermediate package The intermediate package shall have at least the following information. 9.3 Shipping package The shipping package shall have at least the following labels.10 PackagingEach infusion needle shall be sealed in a primary package. The materials and design of this package shall ensure that. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of GB 18671-2009 be delivered?Answer: The full copy PDF of English version of GB 18671-2009 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of GB 18671-2009_English with my colleagues?Answer: Yes. The purchased PDF of GB 18671-2009_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- GB 18671-2009 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.Question 5: Should I purchase the latest version GB 18671-2009?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB 18671-2009 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.How to buy and download a true PDF of English version of GB 18671-2009?A step-by-step guide to download PDF of GB 18671-2009_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).Step 2: Search keyword "GB 18671-2009". Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart. Step 4: Select payment option (Via payment agents Stripe or PayPal). Step 5: Customize Tax Invoice -- Fill up your email etc. Step 6: Click "Checkout". Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively. Step 8: Optional -- Go to download PDF. Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice. See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9 |
