I.S. EN ISO 9626:2016
Current
The latest, up-to-date edition.
STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
01-01-2016
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.
Dates of withdrawal of national standards are available from NSAI.
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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 |
| Standards | Relationship |
| UNE-EN ISO 9626:2017 | Identical |
| NF EN ISO 9626 : 2016 | Identical |
| NEN EN ISO 9626 : 2016 | Identical |
| EN ISO 9626:2016 | Identical |
| BS EN ISO 9626:2016 | Identical |
| DIN EN ISO 9626 E : 2016 | Identical |
| SN EN ISO 9626:2016 | Identical |
| UNI EN ISO 9626 : 2002 | Identical |
| NS EN ISO 9626 : 1995 | Identical |
| NBN EN ISO 9626 : 2016 | Identical |
| DIN EN ISO 9626:2015-03 (Draft) | Identical |
| ISO 9626:2016 | Identical |
| 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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