ISO 1135-4:2015
Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
ISO 1135-4:2015 specifies 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.
Secondary aims of ISO 1135-4:2015 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 a range of cellular and plasma blood components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.
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Foreword
1 Scope
2 Normative references
3 General requirements
3.1 Nomenclature for components of the transfusion set
3.2 Maintenance of sterility
4 Materials
5 Physical requirements
5.1 Particulate contamination
5.2 Leakage
5.3 Tensile strength
5.4 Closure-piercing device
5.5 Tubing
5.6 Filter for blood and blood components
5.7 Drip chamber and drip tube
5.8 Flow regulator
5.9 Flow rate of blood and blood components
5.10 Injection site
5.11 Male conical fitting
5.12 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
7.6 Assessment of blood component depletion
7.7 Assessment of damage to blood components
8 Labelling
8.1 General
8.2 Unit container
8.3 Shelf or multi-unit container
9 Packaging
10 Disposal
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography
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Foreword
1 Scope
2 Normative references
3 General requirements
3.1 Nomenclature for components of the transfusion set
3.2 Maintenance of sterility
4 Materials
5 Physical requirements
5.1 Particulate contamination
5.2 Leakage
5.3 Tensile strength
5.4 Closure-piercing device
5.5 Tubing
5.6 Filter for blood and blood components
5.7 Drip chamber and drip tube
5.8 Flow regulator
5.9 Flow rate of blood and blood components
5.10 Injection site
5.11 Male conical fitting
5.12 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
7.6 Assessment of blood component depletion
7.7 Assessment of damage to blood components
8 Labelling
8.1 General
8.2 Unit container
8.3 Shelf or multi-unit container
9 Packaging
10 Disposal
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography