This part of ISO 8536 specifies requirements for non-sterile, single-use graduated flow regulators used as a single component in sterilized, single-use infusion devices to control the flow of liquid-contact intravenous infusion solutions under gravity conditions. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
EN ISO 8536-13:2016 Referenced Document
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 1135-3:1986 Transfusion equipment for medical use; Part 3 : Blood-taking set
ISO 1135-4:2015 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
ISO 1135-5:2015 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus