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EVS-EN ISO 9626:2016

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

General information
Valid from 04.10.2016
Base Documents
ISO 9626:2016; EN ISO 9626:2016
Directives or regulations
None
Standard history
Status
Date
Type
Name
04.10.2016
Main
09.01.2002
Amendment
01.01.2000
Main
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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