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EN ISO 8536-11:2015

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015) EN ISO 8536-11:2015

Publication date:   Sep 16, 2015

General information

60.60 Standard published   Jun 17, 2015

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536‑8. It does not include the effectiveness of filters for separation of particles or germs.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

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Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8536-11:2004

NOW

PUBLISHED
EN ISO 8536-11:2015
60.60 Standard published
Jun 17, 2015