Name: UNI EN ISO 10555-4 : 2013
Brand: UNI

UNI EN ISO 10555-4 : 2013

Superseded

View Superseded by

INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS

Superseded date

02-20-2024

Published date

09-19-2013

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (normative) - Test for balloon rated burst pressure
        (RBP)
Annex B (normative) - Balloon fatigue test for freedom from
        leakage and damage on inflation
Annex C (normative) - Test for balloon deflation time
Annex D (normative) - Test for balloon diameter to inflation
        pressure
Annex E (informative) - Guidance on the selection of balloon
        materials
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 balloon dilatation catheters supplied in the sterile condition, and intended for single use.

Committee	CT 44
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 10555-4:2024
Supersedes	UNI EN ISO 10555-4 : 1998

Standards	Relationship
SN EN ISO 10555-4 : 2013	Identical
NF EN ISO 10555-4 : 2013	Identical
I.S. EN ISO 10555-4:2013	Identical
ISO 10555-4:2013	Identical
BS EN ISO 10555-4:2013	Identical
NS EN ISO 10555-4 : 2013	Identical
UNE-EN ISO 10555-4:2014	Identical
NEN EN ISO 10555-4 : 2013	Identical
NBN 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