This part of ISO 8536 specifies requirements for types of single-use infusion sets for medical use in order to ensure compati-bility of use with containers for infusion Solutions and intra-venous equipment.
The materials and components of the sets are validated by various test methods (type tests) and, in addition, tests are performed for the release of lots of finished sets (lot tests).
The manufacturer shall select appropriate test methods to comply with the requirements laid down in this part of ISO 8536.
Secondary aims of this part of ISO 8536 are to provide
a) specifications relating to the quality and performance of materials used in infusion sets;
b) a unified presentation of terms and designations for infusion sets.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence ?ver this part of ISO 8536.
This part of ISO 8536 specifies requirements applicable to sterilized infusion sets intended for single use.