BS EN ISO 3826-1:2013

Superseded

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Plastics collapsible containers for human blood and blood components Conventional containers

Available format(s)

Hardcopy , PDF

Superseded date

11-04-2023

Language(s)

English

Published date

30-06-2013

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 A (normative) - Chemical tests
Annex B (normative) - Physical tests
Annex C (normative) - Biological tests
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on Medical devices

Describes 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.

Committee	CH/212
DevelopmentNote	Supersedes 99/563577 DC. (12/2003) Together with BS EN ISO 1135-4 and BS EN ISO 3826-3, supersedes BS 2463-1(1990) and BS 2463-2(1989). (04/2007)
DocumentType	Standard
Pages	34
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 3826-1:2019+A1:2023 BS EN ISO 3826-1:2019
Supersedes	BS EN ISO 3826-1:2003 99/563577 DC : DRAFT JULY 1999 BS 2463-1:1990 BS 2463-2:1989

Standards	Relationship
ONORM EN ISO 3826-1 : 2013	Identical
NS EN ISO 3826-1 : 2013	Identical
SN EN ISO 3826-1 : 2013	Identical
UNE-EN ISO 3826-1:2013	Identical
ISO 3826-1:2013	Identical
DIN EN ISO 3826-1:2013-09	Identical
I.S. EN ISO 3826-1:2013	Identical
UNI EN ISO 3826-1 : 2013	Identical
NBN EN ISO 3826-1 : 2013	Identical
EN ISO 3826-1:2013	Identical
NEN EN ISO 3826-1 : 2013	Identical
NF EN ISO 3826-1 : 2013	Identical

ISO 3826-2:2008	Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets
ISO 10993-4:2017	Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 3826-3:2006	Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
ISO 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 1135-4:2015	Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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BS EN ISO 3826-1:2013

Superseded

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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