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Pre-standard

ISO/TS 10993-20:2006-08

Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices

German title
Biologische Beurteilung von Medizinprodukten - Teil 20: Prinzipien und Verfahren für die immuntoxikologische Prüfung von Medizinprodukten
Publication date
2006-08
Original language
English
Pages
17

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Publication date
2006-08
Original language
English
Pages
17

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Content

Content (en)

  • Foreword
  • Introduction
  • Scope
  • Normative references
  • Terms and definitions
  • Risk assessment and risk management
  • Identification of hazards
  • Methods of assessment of immunotoxicity
  • Extrapolation of data provided by pre-clinical assays
  • Current state of knowledge (informative)
  • Clinical experience with medical devices (informative)
  • Flow chart for immunotoxicity testing (informative)
  • Bibliography
ICS
11.100.20

Cooperation at DIN

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