Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

19-02-2014

Publisher

Asociacion Espanola de Normalizacion

Foreword
1 Scope
2 Normative references
3 Definitions
4 Requirements
Annex A (normative) Test for freedom from leakage and
damage on inflation
Annex B (informative) Guidance on the selection of balloon
materials
Annex C (informative) Bibliography

Defines requirements for sterile, single use balloon dilatation catheters.

Committee	CTN 111
DocumentType	Standard
Pages	22
PublisherName	Asociacion Espanola de Normalizacion
Status	Current
Supersedes	UNE-EN ISO 10555-4:1997

Standards	Relationship
ISO 10555-4:2013	Identical
NF EN ISO 10555-4 : 2013	Identical
NBN EN ISO 10555-4 : 2013	Identical
NEN EN ISO 10555-4 : 2013	Identical
NS EN ISO 10555-4 : 2013	Identical
I.S. EN ISO 10555-4:2013	Identical
SN EN ISO 10555-4 : 2013	Identical
UNI EN ISO 10555-4 : 2013	Identical
BS EN ISO 10555-4:2013	Identical
EN ISO 10555-4:2013	Identical
DIN EN ISO 10555-4:2013-11	Identical
ONORM EN ISO 10555-4 : 2013	Identical

ISO 11070:2014	Sterile single-use intravascular introducers, dilators and guidewires
ISO 25539-2:2012	Cardiovascular implants Endovascular devices Part 2: Vascular stents
ISO 14630:2012	Non-active surgical implants General requirements
ISO/TS 12417:2011	Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
ISO 10555-1:2013	Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 594-2:1998	Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements

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UNE-EN ISO 10555-4:2014

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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