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SSH EN ISO 8536-5:2013

Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)

Apr 23, 2014

General information

60.60     Apr 23, 2014

DPS

DPS/KT 205

European Norm

11.040.20  

English  

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Scope

ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment.
ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials.
In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 8536-5:2011

NOW

PUBLISHED
SSH EN ISO 8536-5:2013
60.60 Standard published
Apr 23, 2014

Related project

Adopted from EN ISO 8536-5:2013