NF EN ISO 10555-1

NF EN ISO 10555-1

August 2013
Standard Cancelled

Intravascular catheters - Sterile and single-use catheters - Part 1 : general requirements

ISO 10555-1:2013 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2013

Number of pages

34 p.

Reference

NF EN ISO 10555-1

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-031-1

Print number

2 - 01/04/2014

International kinship

ISO 10555-1:2013

European kinship

EN ISO 10555-1:2013
Sumary
Intravascular catheters - Sterile and single-use catheters - Part 1 : general requirements

ISO 10555-1:2013 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.

Replaced standards (1)
NF EN ISO 10555-1
August 2009
Standard Cancelled
Sterile, single-use intravascular catheters - Part 1 : general requirements

Le présent document fixe des prescriptions générales relatives aux cathéters intravasculaires stériles non réutilisables. Il ne s'applique pas aux accessoires.

Standard replaced by (1)
NF EN ISO 10555-1
November 2023
Standard Current
Intravascular catheters - Sterile and single-use catheters - Part 1 : general requirements

This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application. This document does not apply to intravascular catheter accessories, e.g. those covered by ISO 11070.

Table of contents
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
  • 3 Termes et définitions
    1
  • 4 Exigences
    4
  • 4.1 Généralités
    4
  • 4.2 Radiodétectabilité
    4
  • 4.3 Biocompatibilité
    4
  • 4.4 Surface
    4
  • 4.5 Résistance à la corrosion
    4
  • 4.6 Force maximale de rupture
    4
  • 4.7 Absence de fuite
    5
  • 4.8 Embases
    5
  • 4.9 Débit
    5
  • 4.10 Injection sous pression
    5
  • 4.11 Orifices latéraux
    5
  • 4.12 Extrémité distale
    5
  • 5 Désignation de la dimension nominale
    5
  • 5.1 Diamètre extérieur
    5
  • 5.2 Longueur utile nominale
    6
  • 6 Informations à fournir par le fabricant
    6
  • 6.1 Généralités
    6
  • 6.2 Marquage du dispositif et/ou du conditionnement primaire
    6
  • 6.3 Mode d'emploi
    7
  • 6.4 Marquage du conditionnement secondaire
    7
  • Annexe A (normative) Méthode d'essai de résistance à la corrosion
    8
  • Annexe B (normative) Méthode de détermination de la force de rupture
    9
  • Annexe C (normative) Méthode d'essai de fuite de liquide sous pression
    11
  • Annexe D (normative) Méthode d'essai de fuite d'air au niveau de l'assemblage de l'embase pendant l'aspiration
    13
  • Annexe E (normative) Détermination du débit au travers du cathéter
    15
  • Annexe F (normative) Essai de pression d'éclatement en conditions statiques
    17
  • Annexe G (normative) Essai d'injection sous pression pour le débit et la pression dans le dispositif (produits indiqués pour l'injection sous pression uniquement)
    20
  • Annexe H (informative) Unités de systèmes de mesure autres que ceux spécifiés dans la présente partie de l'ISO 10555 et qui peuvent être utilisées en complément
    23
  • Bibliographie
    25
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