GB/T 18457-2024 PDF English
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| GB/T 18457-2015 | 125 | Add to Cart | Auto, 9 seconds. | Stainless steel needle tubing for the manufacture of medical devices | Valid |
| GB 18457-2001 | 70 | Add to Cart | Auto, 9 seconds. | Stainless steel needle tubing for manufacture of medical devices | Obsolete |
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GB/T 18457-2024: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
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GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.20 CCS C 31 Replacing GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626.2016, MOD) Issued on. AUGUST 23, 2024 Implemented on. SEPTEMBER 01, 2025 Issued by. State Administration for Market Regulation; National Standardization Administration.
Table of Contents
Foreword... 4 1 Scope... 7 2 Normative references... 7 3 Terms and definitions... 7 4 Materials... 8 5 Requirements and test methods... 8 5.1 General... 8 5.2 Surface roughness and appearance... 8 5.3 Cleanliness... 9 5.4 pH limit... 9 5.5 Size identification... 9 5.6 Size... 9 5.7 Stiffness... 11 5.8 Toughness... 12 5.9 Corrosion resistance... 13 Appendix A (Informative) Stainless steel designations... 14 Appendix B (Normative) Test solution preparation method... 16 B.1 Principle... 16 B.2 Apparatus and reagents... 16 B.3 Preparation procedure... 16 Appendix C (Normative) Test method for stiffness of needle tube... 17 C.1 Principle... 17 C.2 Instrument... 17 C.3 Test procedure... 17 C.4 Test report... 18 Appendix D (Normative) Test method for needle tube toughness... 19 D.1 Principle... 19 D.2 Instrument... 19 D.3 Steps... 19 D.4 Test report... 19 Appendix E (Normative) Needle tube corrosion resistance test method... 21 E.1 Principle... 21 E.2 Reagents and instruments... 21 E.3 Experimental procedure... 21 E.4 Test report... 21 References... 22Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020 "Directives for standardization - Part 1.Rules for the structure and drafting of standardizing documents". This document replaces GB/T 18457-2015 "Stainless steel needle tubing for the manufacture of medical devices". Compared with GB/T 18457-2015, in addition to structural adjustments and editorial changes, the main technical changes are as follows. a) CHANGE the scope, ADD the size of 0.18 mm (34G) (see Chapter 1; Chapter 1 of the 2015 edition); b) ADD the terms and definitions (see Chapter 3); c) CHANGE the requirements for materials (see Chapter 4; Chapter 4 of the 2015 edition); d) ADD the size requirements for ultra-thin walls and very thin walls of some specifications (see Chapter 5); e) ADD the specific size requirements for the nominal outer diameter of 0.18 mm needle tubes (see Table 1); f) CHANGE the requirements for size marking (see 5.5; Chapter 5 of the 2015 edition); g) CHANGE the needle tube size and stiffness parameter table (see 5.7; Chapter 9 of the 2015 edition); h) CHANGE the relevant requirements for the preparation method of the test solution (see Appendix B; Appendix B of the 2015 edition); i) DELETE the "Test method for pH of needle tubes" (see Appendix C of the 2015 edition); j) CHANGE the test method and requirements for needle tube stiffness (see Appendix C; Appendix D of the 2015 edition); k) CHANGE the test method and requirements for needle tube toughness (see Appendix D; Appendix E of the 2015 edition); l) CHANGE the requirements for the needle tube corrosion resistance test report (see E.4; F.4 of the 2015 edition). This document modifies and adopts ISO 9626.2016 "Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods". Compared with ISO 9626.2016, this document has made the following structural adjustments. - DELETE 5.7 of ISO 9626.2016, the subsequent article numbers have been moved forward; - ADD the Appendix A; - Appendix B corresponds to Appendix A of ISO 9626.2016; - Appendix C corresponds to Appendix B of ISO 9626.2016; - Appendix D corresponds to Appendix C of ISO 9626.2016; - Appendix E corresponds to Appendix D of ISO 9626.2016; - DELETE the Appendix E of ISO 9626.2016. The technical differences between this document and ISO 9626.2016, as well as their reasons, are as follows. - CHANGE the material requirements, to meet domestic technical conditions (see Chapter 4; Chapter 4 of ISO 9626.2016); - DELETE the requirements of 5.7 "Sample size" in ISO 9626.2016, to avoid ambiguity with 5.1 General; - USE the normative reference GB/T 6682 to replace ISO 3696 (see B.2.1), to adapt to China’s national conditions; - CHANGE the toughness requirements, to meet domestic technical requirements (see Appendix D; Appendix C of ISO 9626.2016). This document has made the following editorial changes. - DELETE the notes in Chapter 4 of ISO 9626.2016; - ADD the "Stainless steel designations" (see Appendix A); - DELETE the informative Appendix E of ISO 9626.2016 "Basic principles of needle tube stiffness test method". Please note that some contents of this document may involve patents. The issuing agency of this document does not assume the responsibility for identifying patents. This document was proposed by the State Food and Drug Administration. This document shall be under the jurisdiction of the National Technical Committee for Standardization of Medical Syringes (Needles) (SAC/TC 95). The drafting organizations of this document. Zhejiang Kangdeli Medical Devices Co., Ltd., Shanghai Medical Device Inspection Institute, Shandong Weigao Group Medical Polymer Products Co., Ltd., Shanghai Ess Medical Technology Co., Ltd., Jiangxi Sanxin Medical Technology Co., Ltd., B. Braun Medical (Shanghai) International Trade Co., Ltd. The main drafters of this document. Zhang Qian, Lu Liyuan, Hua Songhe, Cong Rinnan, Li Lu, Sun Hongrong, Liu Mian, Wang Ganying, Chang Ming. This standard replaces the standard previously issued as follows. - It was first published in 2001 as GB 18457-2001; it was revised for the first time in 2015; - This is the second revision. Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods1 Scope
This document specifies the requirements for stainless steel needle tubes (hereinafter referred to as needle tubes), which have designated metric sizes ranging from 0.18 mm (34G) to 3.4 mm (10G); describes the test methods.2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, for dated references, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies to this document. GB/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682- 2008, ISO 3696.1987, MOD) ISO 15510.2014 Stainless steels - Chemical composition3 Terms and definitions
The following terms and definitions apply to this document. The material thickness between the inner and outer diameters of the needle tube.4 Materials
The needle tube shall be made of austenitic stainless steels such as X2CrNi18-9, X5CrNi18-10, X6CrNiNb18-10, X5CrNiMo17-12-2, X6CrNiMoTi17-12-2, X6CrNiMoNb17-12-2 in accordance with ISO 15510.2014, or other austenitic stainless steels equivalent to the above steels.5 Requirements and test methods
When observed with normal or corrected vision, the outer surface of the needle tube shall be smooth and free of defects; the needle tube shall be straight and regularly rounded. When observed with normal or corrected vision, the surface of the needle tube shall be free of metal chips and impurities generated during processing. Prepare the test solution according to Appendix B and measure it with a pH meter.Appendix A
(Informative) Stainless steel designations The chemical composition of the stainless steel designations given in this Appendix and the comparison with the stainless steel designations in other international standard and national standard are shown in Tables A.1 ~ A.3. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
