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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

General information

60.60     Jul 17, 2017

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

Life cycle

NOW

PUBLISHED
SSH EN ISO 8536-13:2016
60.60 Standard published
Jul 17, 2017

Related project

Adopted from EN ISO 8536-13:2016

Adopted from ISO 8536-13:2016

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