NF EN ISO 1135-4

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.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2012

Number of pages

24 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 - 30/07/2012

International kinship

ISO 1135-4:2012

European kinship

EN ISO 1135-4:2012
Sumary
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.

Replaced standards (1)
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.

Standard replaced by (2)
NF EN ISO 1135-4
April 2016
Standard Current
Transfusion equipment for medical use - Part 4 : transfusion sets for single use, gravity feed

ISO 1135-4:2015 specifies requirements for single use transfusion gravity 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 1135-4:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.

NF EN ISO 1135-5
April 2016
Standard Current
Transfusion equipment for medical use - Part 5 : transfusion sets for single use with pressure infusion apparatus

ISO 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment. Secondary aims of ISO 1135-5:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components. Platelet components should not be transfused under pressure using these sets. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-5:2015.

Table of contents
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Exigences générales
    2
  • 3.1 Nomenclature des composants d'un 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
    5
  • 5.9 Débit du sang et de ses composants
    5
  • 5.10 Site d'injection
    5
  • 5.11 Raccord conique mâle
    5
  • 5.12 Capuchons protecteurs
    5
  • 6 Exigences chimiques
    5
  • 6.1 Matière réductrice (oxydable)
    5
  • 6.2 Ions métalliques
    5
  • 6.3 Acidité ou alcalinité de titrage
    6
  • 6.4 Matière sèche
    6
  • 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
    8
  • Annexe A (normative) Essais physiques
    9
  • Annexe B (normative) Essais chimiques
    13
  • Annexe C (normative) Essais biologiques
    15
  • Bibliographie
    16
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