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prEN ISO 8536-13

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO/DIS 8536-13:2023) prEN ISO 8536-13

Publication date:   Aug 24, 2023

General information

45.99 Dispatch of FV draft to CCMC   May 12, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

Buying

Draft

Language in which you want to receive the document.

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.

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 8536-13:2016

NOW

IN_DEVELOPMENT
prEN ISO 8536-13
45.99 Dispatch of FV draft to CCMC
May 12, 2024