Abstract 

Specifies methodologies for the evaluation of the systemic toxicity potential of medical devices which release constituents into the body. Includes, in addition, pyrogenicity testing. The methods cited are from international standards, national standards, directives and regulations.


General information

  • Status :  Withdrawn
    Publication date : 1993-12
  • Edition : 1
    Number of pages : 8
  • Technical Committee
    :
    ISO/TC 194
    Biological and clinical evaluation of medical devices
  • ICS :
    11.100.20
    Biological evaluation of medical devices

Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda

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