DS/EN ISO 3826-4:2015

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

Status:

Current

Type:

Standard

Language:

English

Subject:

Sundhed

Price from:

€ 86.05

Legislation:

CE Harmonized

Legislation

Harmonized under:

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:

http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.htm

Scope

This part of EN ISO 3826 specifies requirements, including performance requirements, for apheresis blood bag systems with integrated features. Apheresis blood bag systems need not contain all of the integrated features identified in this document.
The integrated features refer to:
 needle stick protection device;
 leucocyte filter;
 sterile barrier filter;
 pre-collection sampling device;
 red blood cell storage bag;
 plasma storage bag;
 platelet storage bag;
 polymorphonucleic (stem) cell storage bag;
 post collection sampling devices;
 connections for storage solutions, anticoagulant and replacement fluid.
This part of ISO 3826 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. This part of ISO 3826 can be used on automated or semi-automated blood collection systems.

Number of pages: 46

Published: 2015-10-01

Date of approval: 2015-09-15

International relationships : EN ISO 3826-4:2015 IDT ISO 3826-4:2015 IDT

ICS: 11.040.20 - Transfusion, infusion and injection equipment

Item number: M275000

Committees

Committee

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

Danish committee