INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS (ISO 10555-5:2013)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2013

Publisher

National Standards Authority of Ireland

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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.

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
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC amended by Directive 2007/47/EEC

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.

DocumentType	Standard
Pages	25
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 10555-5:1998

Standards	Relationship
UNI 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
UNE-EN ISO 10555-5:2014	Identical
BS EN ISO 10555-5:2013	Identical
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

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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I.S. EN ISO 10555-5:2013

Current

Table of Contents

Abstract

General Product Information

International Equivalents

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