NF EN ISO 1135-5
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.
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.
<p>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.</p> <p>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.</p> <p>In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2011.</p>
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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 Exigences générales
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5 Matériaux
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6 Exigences physiques
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7 Exigences chimiques
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8 Exigences biologiques
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9 Étiquetage
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10 Emballage
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11 Élimination
- Annexe A Essais physiques
- Annexe B Essais chimiques
- Annexe C Essais biologiques
- Annexe D Volume stocké
- Bibliographie
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