DS/EN ISO 3826-3:2008

Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features

Status:
Current
Type:
Standard
Language:
English
Subject:
Sundhed
Price from:
€ 56.88
Legislation:

CE Harmonized

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

This part of ISO 3826 specifies requirements, including performance requirements, for integrated features on plastics collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this standard.
The integrated features refer to:
- leucocyte filter,
- pre-donation sampling device,
- top and bottom bag,
- platelet storage bag,
- needle stick protection device.
In addition to ISO 3826-1, which specifies the requirements of conventional containers, this part of ISO 3826 specifies additional requirements for blood bag systems using multiple units. This part of ISO 3826 does not cover automated blood collection systems.
Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the plastics container as prepared ready for use. Use chemical, physical and biological tests in accordance with ISO 3826-1, where applicable.

Replaces:

Number of pages: 24

Published: 2008-02-22

Date of approval: 2008-01-14

International relationships : EN ISO 3826-3:2007 IDT ISO 3826-3:2006 IDT

ICS: 11.040.20 - Transfusion, infusion and injection equipment

Item number: M219761

Committees

Committee

  • CEN/TC 205
  • ISO/TC 76/WG 1

Danish committee

DS/S-093