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I.S. EN ISO 9626:2016

I.S. 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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
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

Pertains to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.

DocumentType
Standard
Pages
40
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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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Hardcopy - English
PDF - English
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