NF EN ISO 1135-4
Transfusion equipment for medical use - Part 4 : transfusion sets for single use
ISO 1135-4:2004 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.ISO 1135-4:2004 also specifies requirements for air-inlet devices for use with rigid containers for blood and blood components.Secondary aims of ISO 1135-4:2004 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 1135-4:2004.
ISO 1135-4:2004 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.
ISO 1135-4:2004 also specifies requirements for air-inlet devices for use with rigid containers for blood and blood components.
Secondary aims of ISO 1135-4:2004 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 1135-4:2004.
La présente norme décrit les nécessaires pour transfusion en précisant principalement les caractéristiques dimensionnelles et mécaniques du matériel considéré ainsi que les essais permettant de vérifier l'aptitude à l'emploi. La présente norme est complémentaire des monographies de la Pharmacopée française sur le sujet.
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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