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).

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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
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