SRPS EN ISO 8536-13:2017

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)

Scope

ISO 8536-13:2016 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.