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EN ISO 8536-13:2016

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

Publication date:   Jan 18, 2017

General information

99.60   Withdrawal effective   Sep 25, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

NOW

WITHDRAWN
EN ISO 8536-13:2016
99.60 Withdrawal effective
Sep 25, 2024

REVISED BY

PUBLISHED
EN ISO 8536-13:2024




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