CSA ISO 10993-4 : 1997

Cancelled

Cancelled Standard has been cancelled.

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

Publisher: Canadian Standards Association

Published:

Available Formats: PDF - English, Hardcopy - English
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Table of Contents - (Show below) - (Hide below)

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

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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Published
Document Type	Standard
Status	Cancelled
Publisher	Canadian Standards Association
Pages
ISBN

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

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

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

DIN 58361-4 : 1980	TRANSFUSION, INFUSION, TRANSFUSION CONTAINERS AND ACCESSORIES, PLASTIC CONTAINERS FOR BLOOD, REQUIREMENTS, TESTS, SUPERVISION AND LABELLING

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