NF EN ISO 10555-4

NF EN ISO 10555-4

August 2013
Standard Cancelled

Intravascular catheters - Sterile and single-use catheters - Part 4 : balloon dilatation catheters

ISO 10555-4:2013 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2013

Number of pages

22 p.

Reference

NF EN ISO 10555-4

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-031-4

Print number

1 - 02/08/2013

International kinship

ISO 10555-4:2013

European kinship

EN ISO 10555-4:2013
Sumary
Intravascular catheters - Sterile and single-use catheters - Part 4 : balloon dilatation catheters

ISO 10555-4:2013 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.

Replaced standards (1)
NF EN ISO 10555-4
December 1997
Standard Cancelled
Sterile, single-use intravascular catheters. Part 4 : balloon dilatation catheters.

Le présent document fixe les prescriptions relatives aux cathéters de dilatation à ballonnets, non réutilisables, fournis stériles. Il doit être lu en liaison avec la NF EN ISO 10555-1.

Table of contents
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  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences
    1
  • 4.1 Généralités
    1
  • 4.2 Radiodétectabilité
    1
  • 4.3 Désignation de la dimension nominale
    2
  • 4.4 Exigences physiques
    2
  • Annexe A (normative) Essai de la pression nominale d'éclatement du ballonnet
    3
  • Annexe B (normative) Essai de fatigue du ballonnet, absence de fuite et dommages dus au gonflage
    5
  • Annexe C (normative) Essai de temps de dégonflage du ballonnet
    7
  • Annexe D (normative) Essai du diamètre du ballonnet à la pression de gonflage
    9
  • Annexe E (informative) Guide de sélection des matériaux de ballonnets
    11
  • Bibliographie
    12
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