NF ISO 10555-6

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.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

July 2015

Number of pages

21 p.

Reference

NF 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
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.

Standard replaced by (1)
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.

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
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ