Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO/DIS 9626:2025)

Comment end date 2026-01-29

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Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas

2. Projektas

3. Viešoji apklausa

From 2025-11-30 till 2026-01-29

4. Closure of enquiry

5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

11.040.25 - Syringes, needles and catheters

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 205

Number of comments

Comment start date

2025-11-30

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.

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Pakeis

prEN ISO 9626