Abstract

Describes a classification of medical and dental devices that are intended for use in contact with blood, the fundamental principles governing the evaluation of the interaction of devices with blood, and the rationale for structured selection of tests, together with the principles and scientific basis of these tests. Annex A describes evaluation of cardiovascular devices and prostheses during in vivo function.


General information 

  • Status
     :  Withdrawn
    Publication date
     : 1992-12
  • Edition
     : 1
    Number of pages
     : 19
  • Technical Committee
     : ISO/TC 194 Biological and clinical evaluation of medical devices
  • ICS
     :
    11.100 Laboratory medicine

Life cycle


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