NF EN ISO 8536-4

NF EN ISO 8536-4

January 2011
Standard Cancelled

Infusion equipment for medical use - Part 4 : infusion sets for single use, gravity feed

ISO 8536‑4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.Secondary aims of ISO 8536‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2011

Number of pages

25 p.

Reference

NF EN ISO 8536-4

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-123-4

Print number

1 - 13/12/2010

International kinship

ISO 8536-4:2010

European kinship

EN ISO 8536-4:2010
Sumary
Infusion equipment for medical use - Part 4 : infusion sets for single use, gravity feed

ISO 8536‑4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.

Secondary aims of ISO 8536‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.

Replaced standards (1)
NF EN ISO 8536-4
January 2008
Standard Cancelled
Infusion equipment for medical use - Part 4 : infusion sets for single use, gravity feed

ISO 8536-4:2007 specifies requirements for single-use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of ISO 8536-4:2007 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-4:2007.

Standard replaced by (1)
NF EN ISO 8536-4
August 2013
Standard Cancelled
Infusion equipment for medical use - Part 4 : infusion sets for single use, gravity feed

ISO 8536‑4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of ISO 8536‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.

Table of contents
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Exigences générales
    2
  • 4 Désignation
    4
  • 4.1 Appareil de perfusion
    4
  • 4.2 Dispositif de prise d'air
    4
  • 5 Matériaux
    4
  • 6 Exigences physiques
    5
  • 6.1 Contamination particulaire
    5
  • 6.2 Fuites
    5
  • 6.3 Résistance à la traction
    5
  • 6.4 Dispositif perforateur de la fermeture
    5
  • 6.5 Dispositif de prise d'air
    5
  • 6.6 Tubulure
    6
  • 6.7 Filtre à fluide
    6
  • 6.8 Chambre compte-gouttes et tube de goutte-à-goutte
    6
  • 6.9 Régulateur de débit
    6
  • 6.10 Débit du liquide de perfusion
    6
  • 6.11 Site d'injection
    6
  • 6.12 Raccord conique mâle
    6
  • 6.13 Capuchons protecteurs
    7
  • 7 Exigences chimiques
    7
  • 7.1 Matière réductrice (oxydable)
    7
  • 7.2 Ions métalliques
    7
  • 7.3 Titrage de l'acidité ou de l'alcalinité
    7
  • 7.4 Résidus non volatiles
    7
  • 7.5 Absorption UV de la solution d'extrait
    7
  • 8 Exigences biologiques
    7
  • 8.1 Généralités
    7
  • 8.2 Stérilité
    7
  • 8.3 Pyrogénicité
    8
  • 8.4 Hémolyse
    8
  • 8.5 Toxicité
    8
  • 9 Étiquetage
    8
  • 9.1 Présentation individuelle
    8
  • 9.2 Présentation en boite ou en emballage groupé
    9
  • 10 Emballage
    9
  • Annexe A (normative) Essais physiques
    10
  • Annexe B (normative) Essais chimiques
    14
  • Annexe C (normative) Essais biologiques
    16
  • Bibliographie
    17
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