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BS EN ISO 9626 : 2016

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BS EN ISO 9626 : 2016

STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016)

British Standards Institution

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Table of Contents

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

Abstract

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

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Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/84
Supersedes
  • BS 7547(1991) : 1991 AMD 8750
  • 15/30296386 DC : 0
  • 00/560526 DC : DRAFT JAN 2000
  • 88/55196 DC : LATEST