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SSH EN ISO 15747:2011

Plastic containers for intravenous injections (ISO 15747:2010)

Mar 26, 2012
95.99 Withdrawal of Standard   Apr 2, 2020

General information

95.99     Apr 2, 2020

DPS

DPS/KT 316

European Norm

11.040.20  

English  

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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 directives

Directives related to this standards.

93/42/EEC

Medical devices

Harmonized
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

NOW

WITHDRAWN
SSH EN ISO 15747:2011
95.99 Withdrawal of Standard
Apr 2, 2020

REVISED BY

PUBLISHED
SSH EN ISO 15747:2019

Related project

Adopted from EN ISO 15747:2011