UNI EN ISO 10555-5 : 2013
Current
The latest, up-to-date edition.
INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS
19-09-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (normative) - Determination of strength of
union of needle hub and needle tube
Annex B (informative) - Colours for opaque catheter
hubs
Annex C (informative) - Needle point geometries
Annex D (normative) - Determination of liquid leakage
from vent fitting
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
amended by Directive 2007/47/EEC
Bibliography
Defines requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10555-5:2013 | Identical |
| NBN EN ISO 10555-5 : 2013 | Identical |
| EN ISO 10555-5:2013 | Identical |
| DIN EN ISO 10555-5:2013-11 | Identical |
| BS EN ISO 10555-5:2013 | Identical |
| SN EN ISO 10555-5:2013 | Identical |
| NEN EN ISO 10555-5 : 2013 | Identical |
| NS EN ISO 10555-5 : 2013 | Identical |
| NF EN ISO 10555-5 : 2013 | Identical |
| I.S. EN ISO 10555-5:2013 | Identical |
| UNE-EN ISO 10555-5:2014 | Identical |
| ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and guidewires |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| NFX 08 002 : 1983 FD | LIMITED COLLECTION OF COLOURS - DESIGNATION AND CATALOGUE OF CCR COLOURS - SECONDARY STANDARDS |
| DIN 6164-1:1980-02 | DIN COLOUR CHART; SYSTEM BASED ON THE 2 DEGREE STANDARD COLORIMETRIC OBSERVER |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ISO 14972:1998 | Sterile obturators for single use with over-needle peripheral intravascular catheters |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| FED-STD-595 Revision C:2008 | COLORS USED IN GOVERNMENT PROCUREMENT |
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