NF EN ISO 8536-9

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).

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Main informations

Collections

National standards and national normative documents

Publication date

November 2015

Number of pages

23 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

International kinship

ISO 8536-9:2015

European kinship

EN ISO 8536-9:2015
Sumary
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).

Replaced standards (1)
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).

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Matériaux
  • 5 Exigences physiques
  • 6 Exigences chimiques
  • 7 Exigences biologiques
  • 8 Emballage
  • 9 Étiquetage
  • 10 Mise au rebut
  • Annexe A (normative) Essais physiques
  • Annexe B (normative) Essais chimiques
  • Annexe C (normative) Volume résiduel
  • Annexe ZA(informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 93/42/CEE relative aux dispositifs médicaux
  • Bibliographie
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