Overview

This International Standard provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device. The purpose of this International Standard is: a) to include specifications for stainless steel cannula tubes of metric sizes 0,18 mm, 0,2 mm, 0,23 mm, and 0,25 mm, and considerations regarding the introduction of thinner tubes for greater comfort during injection, particularly for infants and pediatric use; b) to include designations of wall thickness in addition to normal-walled and thin-walled; c) to include minimum inside diameters for additional products where possible; and d) to revise the nature of the specification of steels to be used. This International Standard applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in this International Standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this International Standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this International Standard. Guidance on transition periods for implementing the requirements of this standard is given in ISO/TR 19244 "Guidance on transition periods for standards", which has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and catheters". This document has been prepared by Technical Committee ISO/TC 84 (secretariat: DS, Denmark) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN. The responsible committee for this International Standard is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at DIN Standards Committee Medicine (NAMed).

Document: references other documents

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices