Foreword
1 Scope
2 Normative references
3 General requirements
4 Designation
4.1 Infusion set
4.2 Air-inlet device
5 Materials
6 Physical requirements
6.1 Particulate contamination
6.2 Leakage
6.3 Tensile strength
6.4 Closure-piercing device
6.5 Air-inlet device
6.6 Tubing
6.7 Fluid filter
6.8 Drip chamber and drip tube
6.9 Flow regulator
6.10 Flow rate of infusion fluid
6.11 Injection site
6.12 Male conical fitting
6.13 Protective caps
7 Chemical requirements
7.1 Reducing (oxidizable) matter
7.2 Metal ions
7.3 Titration acidity or alkalinity
7.4 Residue on evaporation
7.5 UV absorption of extract solution
8 Biological requirements
8.1 General
8.2 Sterility
8.3 Pyrogenicity
8.4 Haemolysis
8.5 Toxicity
9 Labelling
9.1 Unit container
9.2 Shelf or multi-unit container
10 Packaging
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography