NF EN ISO 10555-6

NF EN ISO 10555-6

August 2017
Standard Current

Intravascular catheters - Sterile and single-use catheters - Part 6 : Subcutaneous implanted ports

ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2017

Number of pages

29 p.

Reference

NF EN ISO 10555-6

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-031-6

Print number

1

International kinship

ISO 10555-6:2015

European kinship

EN ISO 10555-6:2017
Sumary
Intravascular catheters - Sterile and single-use catheters - Part 6 : Subcutaneous implanted ports

ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.

ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.

Replaced standards (1)
NF ISO 10555-6
July 2015
Standard Cancelled
Intravascular catheters - Sterile and single-use catheters - Part 6 : subcutaneous implanted ports

ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use. ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences requises de la chambre à cathéter implantable et du cathéter
  • 5 Compatibilité avec l'imagerie par résonance magnétique (IRM)
  • 6 Informations à fournir par le fabricant
  • Annexe A Méthode d'essai pour vérifier l'absence de fuite d'air
  • Annexe B Détermination du volume de rinçage
  • Annexe C Préconisations concernant les essais de caractérisation complémentaires: pénétration et retrait de l'aiguille
  • Annexe D Méthode d'essai permettant de démontrer l'absence de fuite après de multiples ponctions
  • Annexe E Force maximale de traction
  • Bibliographie
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