Norm

NEN-EN-ISO 3826-1:2013 en

Opvouwbare containers van kunststof voor menselijk bloed en bloedbestanddelen - Deel 1: Conventionele containers

106,87

Over deze norm

Status Definitief
Aantal pagina's 23
Gepubliceerd op 01-06-2013
Taal Engels
This part of ISO 3826 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 part of ISO 3826 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 part of ISO 3826 apply to the plastics container as prepared ready for use. This part of ISO 3826 is not applicable to plastics containers with an integrated filter.

Details

ICS-code 11.040.20
Nederlandse titel Opvouwbare containers van kunststof voor menselijk bloed en bloedbestanddelen - Deel 1: Conventionele containers
Engelse titel Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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