Name: EN 30993-4 : 1993
Brand: CEN

EN 30993-4 : 1993

Superseded

View Superseded by

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

Superseded date

01-10-2002

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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

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

Committee	TC 206
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 10993-4:2017

Standards	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

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

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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EN 30993-4 : 1993

Superseded

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory

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