NF EN ISO 8536-13

Infusion equipment for medical use - Part 13 : graduated flow regulators for single use with fluid contact

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.

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- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

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