Home Cart Quotation About-Us
www.ChineseStandard.net
SEARCH

GB/T 18457-2024 PDF English

US$380.00 · In stock · Download in 9 seconds
GB/T 18457-2024: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
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/T 18457: Historical versions

Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
GB/T 18457-2024380 Add to Cart Auto, 9 seconds. Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods Valid
GB/T 18457-2015125 Add to Cart Auto, 9 seconds. Stainless steel needle tubing for the manufacture of medical devices Valid
GB 18457-200170 Add to Cart Auto, 9 seconds. Stainless steel needle tubing for manufacture of medical devices Obsolete

Similar standards

GB/T 19335   GB 15811   GB 18671   GB/T 14233.3   

GB/T 18457-2024: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods


---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/GBT18457-2024
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... 22

Foreword

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). 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.

1 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 composition

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Designated metric size The outer diameter of the needle tube as defined in Table 1. 3.2 Gauge English (Birmingham) size. Note. A specific gauge size corresponds to a designated metric size with specified outer diameter limits.

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

The needle tube shall be selected based on the specific use and intended use using a risk assessment approach. 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. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Image 1     Image 2     Image 3     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of English version of GB/T 18457-2024 be delivered?Answer: The full copy PDF of English version of GB/T 18457-2024 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/T 18457-2024_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 18457-2024_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+ countries

Question 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- GB/T 18457-2024 -- 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/T 18457-2024?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 18457-2024 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/T 18457-2024?

A step-by-step guide to download PDF of GB/T 18457-2024_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/T 18457-2024".
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