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CSA ISO 10993-4 : 1997

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
Available format(s)

Hardcopy , PDF

Withdrawn date

09-01-2009

Language(s)

English

Published date

01-01-2006

Publisher

Canadian Standards Association

1 Scope
2 Normative reference
3 Definitions
4 Abbreviations
5 Devices contacting blood
   5.1 Non-contact devices
   5.2 External communicating devices
   5.3 Implant devices
6 Tests
   6.1 General recommendations
   6.2 Test methods
   6.3 Types of tests
Annexes
A Evaluation of cardiovascular devices and prostheses
   during in vivo function
B Laboratory tests: principles and scientific basis
C Bibliography

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

DocumentType
Standard
Pages
35
PublisherName
Canadian Standards Association
Status
Withdrawn
Supersedes

Standards Relationship
ISO 10993-4:2017 Identical

CSA Z8638 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
CSA ISO 10993-13 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
CSA ISO 10993-16 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
CSA ISO 10993-9 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
CSA Z8637 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS

ASTM F 756 : 2017 : REDLINE Standard Practice for Assessment of Hemolytic Properties of Materials
ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
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)
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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