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UNE-EN ISO 9626:2017

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Published date

12-04-2017

€94.80
Excluding VAT

ISO 9626 provides requirements and test methods for the tube 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.This International Standard specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (G10) to 0,18 mm (G34).This International Standard 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 does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in this International Standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this International Standard.

Committee
CTN 111
DevelopmentNote
Supersedes UNE 111497. (07/2003)
DocumentType
Standard
Pages
33
PublisherName
Asociación Española de Normalización
Status
Current

ISO 15510:2014 Stainless steels — Chemical composition
ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ISO 14971:2007 Medical devices — Application of risk management to medical devices

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€94.80
Excluding VAT