Standard No.:	GB/T 18457-2015
English Name:	Stainless steel needle tubing for the manufacture of medical devices
Chinese Name:	制造医疗器械用不锈钢针管
Professional Classification:	GB    National Standard
Source Content Issued by:	AQSIQ;SAC
Issued on:	2015-12-10
Implemented on:	2017-1-1
Status:	superseded
Superseded by:	GB/T 18457-2024 Stainless steel needle tubing for the manufacture of medical devices—Requirements and test methods
Superseded on:	2025-9-1
Superseding:	GB 18457-2001 Stainless steel needle tubing for manufacture of medical devices
Target Language:	English
File Format:	PDF
Word Count:	8500 words
Translation Price(USD):	120.0
Delivery:	via email in 1 business day

1 Scope This standard specifies the dimensions, surface and mechanical properties of normal-walled and thin-walled stainless steel tubing of designated metric sizes 0.2 mm~3.4 mm and of extra-thin-walled tubing of designated metric sizes 0.6 mm~2.1 mm. This standard applies to intradermal, subcutaneous, muscle and vein hypodermic needle tubing for human use and rigid stainless tubing (hereinafter referred to as tubing) for other medical devices. It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in this standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this standard. 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 6682 Water for Analytical Laboratory Use-Specification and Test Methods(GB/T 6682-2008, ISO 3696: 1987: MOD) GB/T 14233.1-2008 Test Methods for Infusion Transfusion Injection Equipments for Medical Use - Part 1: Chemical Analysis Methods ISO/TS 15510: 2003 Stainless Steels - Chemical Composition 3 Materials Tubing shall be made from austenitic stainless steel of types X2CrNi18-9, X5CrNi18-9, X6CrNiNb18-10, X5CrNiMo17-12-2, X6CrNiMoTi17-12-2 or X6CrNiMoNb17-12-2 in accordance with ISO/TS 15510: 2003 or from other equivalent austenitic stainless steel. Annex A gives the comparison table for designations and chemical compositions of equivalent austenitic stainless steel. 4 Dimensions The outside diameter, inside diameter and dimensions of tubing shall be in accordance with those specified in Table 1. Table 1 Dimensions of Tubing

Foreword I 1 Scope 2 Normative References 3 Materials 4 Dimensions 5 Size Designation 6 Surface Finish 7 Cleanliness 8 Acidity or Alkalinity 9 Stiffness 10 Resistance to Breakage 11 Resistance to Corrosion Annex A (Informative) Stainless Steel Designations Annex B (Normative) Method of Preparation of Extracts Annex C (Normative) Determination of Acidity or Alkalinity of Tubing Annex D (Normative) Test Method for Stiffness of Tubing Annex E (Normative) Test Method for Resistance of Tubing to Breakage Annex F (Normative) Test Method for Resistance to Corrosion