This International ISO 8536-13 standard specifies requirements for non-sterile, disposable graduated flow regulators used as subcomponents in sterilized infusion sets to control the flow of intravenous infusion solutions by fluid contact under gravity feed conditions.
In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
Graduated flow regulators (GFR) will be designed for constant flow and constant flow regulation. The graduated flow regulator shall be designed for safe use and clearly indicate open and closed (closed) positions to prevent accidental changes in flow rate.
The nomenclature to be used for components of infusion sets and a separate air intake device should be specified. These figures show examples of configuration of infusion sets and air intake devices; other configurations may be used, provided they produce the same results. Infusion sets should only be used for collapsible plastic containers.
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