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SRPS EN ISO 9626:2017

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

Sep 25, 2017

General information

60.60     Sep 25, 2017



European Norm

11.040.25     11.040.20  


plan 2017.



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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.

Life cycle


SRPS EN ISO 9626:2011


SRPS EN ISO 9626:2017
60.60 Standard published
Sep 25, 2017

Related project

Adopted from EN ISO 9626:2016

Adopted from ISO 9626:2016