EN ISO 8536-4:2013

Name: EN ISO 8536-4:2013
Brand: CEN
SKU: EN ISO 8536-4:2013
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Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010) EN ISO 8536-4:2013

Publication date: Mar 19, 2013

General information

Current stage: 99.60 Withdrawal effective Jan 29, 2020

Originator: CEN

Owner: CEN/TC 205 Non-active medical devices

Type: European Norm

ICS: 11.040.20 Transfusion, infusion and injection equipment

Buying

Status: Withdrawn

Scope

ISO 8536‑4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of ISO 8536‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8536-4:2010

NOW

WITHDRAWN
EN ISO 8536-4:2013
99.60 Withdrawal effective
Jan 29, 2020

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN ISO 8536-4:2013/A1:2013

REVISED BY

PUBLISHED
EN ISO 8536-4:2020