Plastics collapsible containers for human blood and blood components Blood bag systems with integrated features

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-04-2008

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions and designation
5 Design
6 Requirements
7 Packaging
8 Labelling
9 Anticoagulant and/or preservative solution
Annex ZA (informative) - Relationship between
                         this European Standard
                         and the Essential Requirements
                         of EU Directive 93/42/EEC
                         Medical Device

Describes requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems).

This part of ISO3826 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this document.

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 ISO3826-1, which specifies the requirements of conventional containers, this part of ISO3826 specifies additional requirements for blood bag systems using multiple units. This part of ISO3826 does not cover automated blood collection systems.

Unless otherwise specified, all tests specified in this part of ISO3826 apply to the plastic container as prepared ready for use. Use chemical, physical and biological tests in accordance with ISO3826-1, where applicable.

Committee	CH/212
DevelopmentNote	Renumbers and supersedes BS ISO 3826-3. 2007 version incorporates corrigendum to BS ISO 3826-3. Together with BS EN ISO 1135-4 and BS EN ISO 3826-1, supersedes BS 2463-1(1990) and BS 2463-2(1989). Supersedes 07/30166744 DC. (04/2008)
DocumentType	Standard
Pages	20
PublisherName	British Standards Institution
Status	Current
Supersedes	BS ISO 3826-3 : 2006 07/30166744 DC : 0 BS 2463-1:1990 BS 2463-2:1989

Standards	Relationship
DIN EN ISO 3826-3:2008-03	Identical
NS EN ISO 3826-3 : 1ED 2007	Identical
NEN EN ISO 3826-3 : 2008	Identical
ISO 3826-3:2006	Identical
SN EN ISO 3826-3:2008	Identical
NF EN ISO 3826-3 : 2008	Identical
I.S. EN ISO 3826-3:2007	Identical
EN ISO 3826-3:2007	Identical
NBN EN ISO 3826-3 : 2008	Identical

ISO 3826-1:2013

Plastics collapsible containers for human blood and blood components Part 1: Conventional containers

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BS EN ISO 3826-3:2007

Plastics collapsible containers for human blood and blood components Blood bag systems with integrated features

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory