Shopping cart 0
Standard

ISO 10993-1:2009

Withdrawn

Note: This standard has a draft: ISO/FDIS 10993-1

Preview

Corrigendums and amendments are bought separately.

Language
Services

Abstract

ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device; the assessment of the biological safety of the medical device.

Document information

  • Standard from ISO
  • Published:
  • Withdrawn:
  • Expires:
  • Edition: 4
  • Version: 1
  • Document type: IS
  • Pages
  • ICS 11.100.20
  • ISO TC ISO/TC 194

Product Relations

Product life cycle