NEN EN ISO 1135-4 : 2016

1 Scope
2 Normative references
3 General requirements
   3.1 Nomenclature for components of the transfusion set
   3.2 Maintenance of sterility
   3.3 Designation
4 Materials
5 Physical requirements
   5.1 Particulate contamination
   5.2 Leakage
   5.3 Tensile strength
   5.4 Closure-piercing device
   5.5 Air-Inlet device
   5.6 Tubing
   5.7 Filter for blood and blood components
   5.8 Drip chamber and drip tube
   5.9 Flow regulator
   5.10 Flow rate of blood and blood components
   5.11 Injection site
   5.12 Male conical fitting
   5.13 Protective caps
6 Chemical requirements
   6.1 Reducing (oxidizable) matter
   6.2 Metal ions
   6.3 Titration acidity or alkalinity
   6.4 Residue on evaporation
   6.5 UV absorption of extract solution
7 Biological requirements
   7.1 General
   7.2 Sterility
   7.3 Pyrogenicity
   7.4 Haemolysis
   7.5 Toxicity
8 Labelling
   8.1 Unit container
   8.2 Shelf or multi-unit container
9 Packaging
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography

Defines 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.