ISO 1135-3:2016
Transfusion equipment for medical use — Part 3: Blood-taking sets for single use
ISO 1135-3:2016 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.
ISO 1135-3:2016 also aims to provide
a) specifications relating to the quality and performance of materials used in transfusion equipment, and
b) a unified presentation of terms for such equipment.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-3:2016.
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Foreword
1 Scope
2 Normative references
3 General requirements
3.1 Types of sets
3.2 Blood taking assembly
3.3 Air-outlet assembly
3.4 Sterilization
3.5 Maintenance of sterility
4 Materials
5 Physical requirements
5.1 Particulate contamination
5.2 Leakage
5.3 Tensile strength
5.4 Bottle needle
5.5 Air-outlet needle
5.6 Blood-taking needle
5.7 Tubing
5.8 Flow regulator
5.9 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 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 Types of sets
3.2 Blood taking assembly
3.3 Air-outlet assembly
3.4 Sterilization
3.5 Maintenance of sterility
4 Materials
5 Physical requirements
5.1 Particulate contamination
5.2 Leakage
5.3 Tensile strength
5.4 Bottle needle
5.5 Air-outlet needle
5.6 Blood-taking needle
5.7 Tubing
5.8 Flow regulator
5.9 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 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