Nezařazeno

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 7.05.2018
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This document 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 this document 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.

NOTE          In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 20.05.2018
Zobraz více Zobraz méně
 

This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged.

This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.

Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use.

This document is not applicable to plastics containers with an integrated filter.

NOTE          In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.