EN ISO 15747:2010

Plastic containers for intravenous injections (ISO 15747:2010)

Publication date:   Dec 17, 2010

General information

99.60 Withdrawal effective   Oct 19, 2011

CEN

CEN/BT

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
ISO 15747:2010 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15747:2005

NOW

WITHDRAWN
EN ISO 15747:2010
99.60 Withdrawal effective
Oct 19, 2011

REVISED BY

WITHDRAWN
EN ISO 15747:2011