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SSH 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)

Oct 20, 2017
95.99 Withdrawal of Standard   Jul 28, 2025

General information

95.99     Jul 28, 2025

DPS

DPS/KT 205

European Norm

11.040.20  

English  

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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 directives

Directives related to this standards.

93/42/EEC

Medical devices

Directive 93/42/EEC

Life cycle

NOW

WITHDRAWN
SSH EN ISO 8536-13:2016
95.99 Withdrawal of Standard
Jul 28, 2025

REVISED BY

PUBLISHED
SSH EN ISO 8536-13:2024

Related project

Adopted from EN ISO 8536-13:2016

Adopted from ISO 8536-13:2016