NEN EN ISO 1135-4 : 2016
Current
The latest, up-to-date edition.
12-01-2013
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
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