NF EN ISO 8536-11

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.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2015

Number of pages

20 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

International kinship

ISO 8536-11:2015

European kinship

EN ISO 8536-11:2015
Sumary
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.

Replaced standards (1)
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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Conception
  • 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) Essais biologiques
  • Annexe ZA(informative) Relation entre la présente norme européenne et les exigences essentielles de la Directive UE 93/42/CEE applicables aux dispositifs médicaux
  • Bibliographie
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