NF S94-370

NF S94-370

April 1999
Standard Current

Surgical implants. Implantable catheter chambers. Intravenous, intraaterial, intraperitoneal, intrathecal and epidural use.

Le présent document détermine les caractéristiques des chambres à cathéter implantables, ainsi que les méthodes d'essai.

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Main informations

Collections

National standards and national normative documents

Publication date

April 1999

Number of pages

22 p.

Reference

NF S94-370

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-370

Print number

1 - 19/03/1999
Sumary
Surgical implants. Implantable catheter chambers. Intravenous, intraaterial, intraperitoneal, intrathecal and epidural use.

Le présent document détermine les caractéristiques des chambres à cathéter implantables, ainsi que les méthodes d'essai.
Table of contents
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  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Définitions
    5
  • 4 Caractéristiques de la chambre à cathéter implantable
    5
  • 5 Caractéristiques de la membrane
    7
  • 6 Caractéristiques de la jonction ou du cathéter
    7
  • 7 Stérilisation
    8
  • 8 Protecteur individuel de stérilité - Emballage primaire
    8
  • 9 Étiquetage
    9
  • 10 Marquage
    9
  • 11 Notice d'instructions
    9
  • Annexe A (normative) Essai d'étanchéité
    11
  • Annexe B (normative) Essai de comportement au rinçage
    12
  • Annexe C (normative) Essai de pénétration et de retrait de l'aiguille
    15
  • Annexe D (normative) Caractère auto-obturant
    16
  • Annexe E (normative) Essai de résistance de la jonction
    17
  • Annexe F (informative) Bibliographie
    18
  • Annexe G (informative) Exemple de modèle possible de Carnet de Surveillance
    19
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