60.60 Standard published Mar 6, 2019
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document 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.
NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.
Legislation related to this standard
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
WITHDRAWN
EN ISO 15747:2011
PUBLISHED
EN ISO 15747:2019
60.60
Standard published
Mar 6, 2019
IN_DEVELOPMENT
prEN ISO 15747 rev