NF EN ISO 8536-9

NF EN ISO 8536-9

June 2005
Standard Cancelled

Infusion equipment for medical use - Part 9 : fluid lines for use with pressure infusion equipment

ISO 8536:2004 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).The following items are covered by ISO 8536:2004:syringe pump lines (SPL);connecting lines (CL); andlines with integrated injection cannula (LIC).

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

June 2005

Number of pages

14 p.

Reference

NF EN ISO 8536-9

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-123-9

Print number

1 - 21/06/2005

International kinship

ISO 8536-9:2004

European kinship

EN ISO 8536-9:2004
Sumary
Infusion equipment for medical use - Part 9 : fluid lines for use with pressure infusion equipment

ISO 8536:2004 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).

The following items are covered by ISO 8536:2004:

  • syringe pump lines (SPL);
  • connecting lines (CL); and
  • lines with integrated injection cannula (LIC).
Standard replaced by (1)
NF EN ISO 8536-9
November 2015
Standard Current
Infusion equipment for medical use - Part 9 : fluid lines for single use with pressure infusion equipment

ISO 8536-9:2015 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by ISO 8536-9:2015: a) syringe pump lines (SPL); b) connecting lines (CL); c) lines with integrated injection cannula (LIC).

Table of contents
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Désignation
    2
  • 4 Matériaux
    2
  • 5 Exigences physiques
    2
  • 5.1 Transparence
    2
  • 5.2 Contamination particulaire
    2
  • 5.3 Résistance à la rupture
    2
  • 5.4 Étanchéité
    2
  • 5.5 Adaptateurs à raccords coniques mâle et/ou femelle
    2
  • 5.6 Accessoires
    3
  • 5.7 Filtres
    3
  • 5.8 Volume résiduel
    3
  • 5.9 Aiguilles à injection
    3
  • 5.10 Protecteurs
    3
  • 6 Exigences chimiques
    3
  • 7 Exigences biologiques
    3
  • 7.1 Stérilité
    3
  • 7.2 Pyrogènes
    3
  • 7.3 Hémolyse
    3
  • 8 Emballage
    3
  • 9 Étiquetage
    4
  • 9.1 Emballage primaire
    4
  • 9.2 Emballage secondaire
    4
  • Annexe A (normative) Essais physiques
    5
  • Annexe B (normative) Essais chimiques
    6
  • Annexe C (normative) Essais biologiques
    7
  • Bibliographie
    8
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