ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.