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EN ISO 8536-5:2013

Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004) EN ISO 8536-5:2013

Publication date:   Mar 19, 2013

General information

60.60 Standard published   Feb 6, 2013

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Published

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

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Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8536-5:2011

NOW

PUBLISHED
EN ISO 8536-5:2013
60.60 Standard published
Feb 6, 2013

REVISED BY

IN_DEVELOPMENT
prEN ISO 8536-5 rev

Relations

Adopted from ISO 8536-5:2004 IDENTICAL