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BS EN 30993-4:1994

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Biological evaluation of medical devices Selection of tests for interactions with blood
Available format(s)

Hardcopy , PDF

Superseded date

11-14-2002

Language(s)

English

Published date

04-15-1994

Publisher

British Standards Institution

Cooperating organizations
National foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Abbreviations
5 Devices contacting blood
6 Tests
Annex A (informative) - Evaluation of cardiovascular devices
        and prostheses during in vivo function
Annex B (informative) - Laboratory tests: principles and
        scientific basis
Annex C (informative) - Bibliography
National annex NA (informative) - Committees responsible
National annex NB (informative) - Cross-reference

Provides guidance to agencies, manufacturers, research laboratories and others for evaluating the interactions of medical devices with blood.

Committee
CH/194
DevelopmentNote
Supersedes BS 5736-11(1990) & 91/55175 DC. (12/2008)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
SN EN 30993-4 : 1994 Identical
NBN EN 30993-4 : 1994 Identical
ISO 10993-4:2017 Identical
UNI EN 30993-4 : 1995 Identical
UNE-EN 30993-4:1994 Identical
NF EN 30993-4 : 1994 Identical
I.S. EN 30993-4:1994 Identical
EN 30993-4 : 1993 Identical
DIN EN 30993-4:1994-06 Identical

15/30290736 DC : 0 BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD

ASTM F 756 : 2017 : REDLINE Standard Practice for Assessment of Hemolytic Properties of Materials
ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
NFS 90 300 : 1981
AAMI CVP3 : 1981 CARDIAC VALVE PROSTHESES
ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
BS EN 30993-1:1994 Biological evaluation of medical devices Guidance on selection of tests
AAMI VP20 : 2ED 94 CARDIOVASCULAR IMPLANTS - VASCULAR GRAFT PROSTHESES
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 5841-3:2013 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
DIN 58361-4:1980-09 TRANSFUSION, INFUSION, TRANSFUSION CONTAINERS AND ACCESSORIES, PLASTIC CONTAINERS FOR BLOOD, REQUIREMENTS, TESTS, SUPERVISION AND LABELLING
ISO 5841-1:1989 Cardiac pacemakers Part 1: Implantable pacemakers

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PDF - English
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