Abstract

Specifies requirements and guidance on procedures to be followed in the preparation of samples of medical devices for testing in biological systems. Includes test material selection, selection of representative portions from a device and selection of reference materials to demonstrate the suitability of the test system.


General information 

  • Status
     :  Withdrawn
    Publication date
     : 1996-09
  • Edition
     : 1
    Number of pages
     : 11
  • Technical Committee
     : ISO/TC 194 Biological and clinical evaluation of medical devices
  • ICS
     :
    11.100 Laboratory medicine

Life cycle


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