NF EN ISO 1135-4

NF EN ISO 1135-4

August 2010
Standard Cancelled

Transfusion equipment for medical use - Part 4 : transfusion sets for single use

ISO 1135‑4:2010 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.Secondary aims of ISO 1135‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135‑4:2010.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2010

Number of pages

23 p.

Reference

NF EN ISO 1135-4

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-253-4

Print number

1 - 12/08/2010

International kinship

ISO 1135-4:2010

European kinship

EN ISO 1135-4:2010
Sumary
Transfusion equipment for medical use - Part 4 : transfusion sets for single use

ISO 1135‑4:2010 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.

Secondary aims of ISO 1135‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135‑4:2010.

Replaced standards (1)
NF EN ISO 1135-4
January 2005
Standard Cancelled
Transfusion equipment for medical use - Part 4 : transfusion sets for single use

Le présent document spécifie les exigences relatives aux appareils de transfusion non réutilisables à usage médical, afin d'assurer leur compatibilité d'emploi avec les récipients pour le sang et les produits du sang et les dispositifs de ponctions veineuses.

Standard replaced by (1)
NF EN ISO 1135-4
August 2012
Standard Cancelled
Transfusion equipment for medical use - Part 4 : transfusion sets for single use

ISO 1135-4:2011 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Secondary aims of ISO 1135-4:2011 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2011.

Table of contents
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Exigences générales
    2
  • 3.1 Nomenclature des composants de l'appareil de transfusion
    2
  • 3.2 Maintien de la stérilité
    3
  • 3.3 Désignation
    3
  • 4 Matériaux
    3
  • 5 Exigences physiques
    3
  • 5.1 Contamination particulaire
    3
  • 5.2 Fuite
    3
  • 5.3 Résistance à la traction
    3
  • 5.4 Dispositif de percement d'opercule
    3
  • 5.5 Tubulure
    4
  • 5.6 Filtre pour le sang et ses composants
    4
  • 5.7 Chambre compte-gouttes et tube compte-gouttes
    4
  • 5.8 Régulateur de débit
    4
  • 5.9 Débit de sang et de composants du sang
    5
  • 5.10 Site d'injection
    5
  • 5.11 Raccord conique mâle
    5
  • 5.12 Capuchons de protection
    5
  • 6 Exigences chimiques
    5
  • 6.1 Matière réductrice (oxydable)
    5
  • 6.2 Ions métalliques
    5
  • 6.3 Acidité ou alcalinité de titrage
    5
  • 6.4 Matière sèche
    5
  • 6.5 Absorption UV de la solution d'extrait
    6
  • 7 Exigences biologiques
    6
  • 7.1 Généralités
    6
  • 7.2 Stérilité
    6
  • 7.3 Pyrogénicité
    6
  • 7.4 Hémolyse
    6
  • 7.5 Toxicité
    6
  • 8 Étiquetage
    6
  • 8.1 Conteneur unitaire
    6
  • 8.2 Boite ou conteneur de plusieurs unités
    7
  • 9 Emballage
    7
  • 10 Élimination
    7
  • Annexe A (normative) Essais physiques
    8
  • Annexe B (normative) Essais chimiques
    12
  • Annexe C (normative) Essais biologiques
    14
  • Bibliographie
    15
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