EN ISO 1135-5:2015

European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Labelling
10 Packaging
11 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Annex D (normative) - Storage volume
Bibliography
Annex ZA (informative) - Relationship between this
          European Standard and the Essential
          Requirements of EU Directive 93/42/EEC on
          Medical devices

ISO 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment.Secondary aims of ISO 1135-5:2015 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 red cell and plasma blood components.Platelet components should not be transfused under pressure using these sets.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-5:2015.