ISO 9626:2016

Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods

Publication date: 2 gush 2016

General information

Current stage: 90.92 Effective date: 5 gush 2024

Originator: ISO

Owner: ISO/TC 84

Type: International Standard

ICS: 11.040.25

Gjuha: anglisht frëngjisht

Buying

Statusi: Publikuar

PDF - 14 925 Lekë

Paper - 14 925 Lekë

CD - 14 925 Lekë

Language

Language in which you want to receive the document.

Scope

ISO 9626:2016 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 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.
It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).
It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.