NF EN ISO 8536-11

NF EN ISO 8536-11

June 2005
Standard Cancelled

Infusion equipment for medical use - Part 11 : infusion filters for use with pressure infusion equipment

ISO 8536-11:2004 applies to sterilized infusion filters for single use up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs.

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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 8536-11

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-123-11

Print number

1 - 21/06/2005

International kinship

ISO 8536-11:2004

European kinship

EN ISO 8536-11:2004
Sumary
Infusion equipment for medical use - Part 11 : infusion filters for use with pressure infusion equipment

ISO 8536-11:2004 applies to sterilized infusion filters for single use up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs.

Standard replaced by (1)
NF EN ISO 8536-11
November 2015
Standard Current
Infusion equipment for medical use - Part 11 : infusion filters for single use with pressure infusion equipment

ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536‑8. It does not include the effectiveness of filters for separation of particles or germs.

Table of contents
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Désignation
    1
  • 4 Conception
    1
  • 5 Matériaux
    1
  • 6 Exigences physiques
    2
  • 6.1 Transparence
    2
  • 6.2 Contamination particulaire
    2
  • 6.3 Résistance à la rupture
    2
  • 6.4 Étanchéité
    2
  • 6.5 Adaptateurs à raccords coniques mâle et/ou femelle
    2
  • 6.6 Protecteurs
    2
  • 7 Exigences chimiques
    2
  • 8 Exigences biologiques
    2
  • 8.1 Stérilité
    2
  • 8.2 Recherche des pyrogènes
    2
  • 8.3 Hémolyse
    3
  • 9 Emballage
    3
  • 10 Étiquetage
    3
  • 10.1 Emballage primaire
    3
  • 10.2 Emballage secondaire
    3
  • Annexe A (normative) Essais physiques
    5
  • Annexe B (normative) Essais chimiques
    6
  • Annexe C (normative) Essais biologiques
    7
  • Bibliographie
    8
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