EN 30993-4 : 1993

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD

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Superseded date: 01-10-2002

Language(s):

Published date: 12-01-2013

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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

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Committee	TC 206
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 10993-4:2017

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Equivalent Standard(s)	Relationship
UNE-EN 30993-4:1994	Identical
ISO 10993-4:2017	Identical
NF EN 30993-4 : 1994	Identical
SN EN 30993-4 : 1994	Identical
NBN EN 30993-4 : 1994	Identical
UNI EN 30993-4 : 1995	Identical
BS EN 30993-4:1994	Identical
I.S. EN 30993-4:1994	Identical
NEN ISO 10993-4 : 1994	Identical
NS ISO 10993-4 : 1994	Identical
DIN EN 30993-4:1994-06	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

EN 12011 : 1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
I.S. EN 12442-1:2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
BS EN 12442-1:2000	Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk
I.S. EN 12011:1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
BS EN 12011:1998	Instrumentation to be used in association with non-active surgical implants. General requirements
EN 12442-1 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK

Standards Referencing This Book - (Show below) - (Hide below)

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
BS 5736-11:1990	Evaluation of medical devices for biological hazards Method of test for haemolysis
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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