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NBN EN ISO 10993-4 : 2009

Current

Current

The latest, up-to-date edition.

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

Published date

12-01-2013

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Types of devices in contact with blood
  (as categorised in ISO 10993-1)
  5.1 Non-contact devices
  5.2 External communicating devices
  5.3 Implant devices
6 Characterization of blood interactions
  6.1 General requirements
  6.2 Categories of tests and blood interactions
  6.3 Types of test
Annex A (informative) Preclinical evaluation of
        cardiovascular devices and prostheses
Annex B (informative) Laboratory tests - Principles,
        scientific basis and interpretation
Annex C (informative) Evaluation of haemolytic properties
        of medical devices and their components
Bibliography

Gives general requirements for evaluating the interactions of medical devices with blood.

DevelopmentNote
Supersedes NBN EN 30993-4. (06/2007)
DocumentType
Standard
PublisherName
Belgian Standards
Status
Current

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