BS 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
30-09-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/84
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| DevelopmentNote |
Supersedes 00/560526 DC and 88/55196 DC. (01/2002) 1995 version incorporates 8750 amendment to BS 7547(1991). Renumbers and supersedes BS 7547(1991). (10/2005) Supersedes 15/30296386 DC. (09/2016)
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| DocumentType |
Standard
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| Pages |
34
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| PublisherName |
British Standards Institution
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| Status |
Current
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| Supersedes |
This International Standard applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.
This International Standard 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.
This International Standard specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4mm (10 Gauge) to 0,18mm (34 Gauge).
It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in this International Standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this International Standard.
| 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 |
| 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 |
| I.S. EN ISO 9626:2016 | Identical |
| NBN EN ISO 9626 : 2016 | Identical |
| DIN EN ISO 9626:2015-03 (Draft) | Identical |
| ISO 9626:2016 | Identical |
| BS 5081-2(1993) : 1993 AMD 9104 | STERILE HYPODERMIC SYRINGES AND NEEDLES - SPECIFICATION FOR STERILE HYPODERMIC NEEDLES FOR SINGLE USE |
| 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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