NA 176

DIN Standards Committee Health Technologies

Project

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

Abstract

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.

Begin

2024-08-10

WI

00205408

Planned document number

DIN EN ISO 9626 rev

Project number

17600117

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 84/WG 10 - Needles  

previous edition(s)

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016
2016-12

Order from DIN Media

Contact

Dipl.-Ing. (FH)

Björn Hermes

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2404
Fax: +49 30 2601-42404

Send message to contact