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CEN
EN ISO 9626:2016

EN ISO 9626:2016

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)

Published date

08-31-2016

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Requirements
Annex A (normative) - Methods for preparation
        of extracts
Annex B (normative) - Test method for stiffness
        of tubing
Annex C (normative) - Test method for resistance
        of tubing to breakage
Annex D (normative) - Test method for resistance
        to corrosion
Annex E (informative) - Rationale with respect to
        test method for stiffness of tubing
Bibliography

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.

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
I.S. EN ISO 8537:2016 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
I.S. EN ISO 7864:2016 STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
UNE-EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
BS EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

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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