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
