DS/EN ISO 3826-1:2019

Sammenklappelige plastbeholdere til humant blod og komponenter af humant blod – Del 1: Konventionelle beholdere


Status:
Gældende
Type:
Standard
Sprog:
Engelsk
Kategori:
Pris fra:
kr. 555,00

Beskrivelse

This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics 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 can 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.


Antal sider: 36

Udgivet: 2019-10-22

Godkendelsesdato: 2019-10-21

Internationale relationer : EN ISO 3826-1:2019 IDT ISO 3826-1:2019 IDT

ICS: 11.040.20 - Transfusions-, infusions- og injektionsudstyr

Varenummer: M322598


Udvalg og komiteer

Komite

  • CEN/TC 205
  • ISO/TC 76
  • ISO/TC 76/WG 1

Dansk udvalg

DS/S-093