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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

60.60 Standard published   Oct 19, 2016

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

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Life cycle

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PUBLISHED
EN ISO 8536-13:2016
60.60 Standard published
Oct 19, 2016

REVISED BY

IN_DEVELOPMENT
prEN ISO 8536-13