BS EN ISO 1135-4:2015

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

Describes 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.

This part of ISO 1135 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 this part of ISO 1135 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 this part of ISO 1135.