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PREN ISO 3826-1 : DRAFT 2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
Superseded date

06-01-2013

Published date

01-12-2013

Publisher

Comite Europeen de Normalisation

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

Defines 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
TC 205
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

PREN 15986 : DRAFT 2009 SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
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 1135-3:2016 Transfusion equipment for medical use Part 3: Blood-taking sets for single use
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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