Standard

NS-EN ISO 9626:2016

Nov 2016 Published

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Language English

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Abstract

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.

Document information

Standard from SN
Published: 1 November 2016
Edition: 2016-08
Version: 1
Document type: NAT
ISBN:

ICS 11.040.20
ICS 11.040.25
National Committee CEN/TC 205

Product Relations

Refers: ISO 15510:2014
Refers: ISO 15510:2014
Refers: ISO 15510:2014
Replaces: NS-EN ISO 9626:1995
Refers: ISO 3696:1987
Adopted from: EN ISO 9626:2016 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 9626:1995/A1:2001

Withdrawn

NS-EN ISO 9626:1995
Current product

Published

NS-EN ISO 9626:2016

NS-EN ISO 9626:2016

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