BS EN ISO 10993-10:2013
Biological evaluation of medical devices. Tests for irritation and skin sensitization

Standard No.
BS EN ISO 10993-10:2013
Release Date
2014
Published By
British Standards Institution (BSI)
Status
 2023-02
Replace By
BS EN ISO 10993-10:2023
Latest
BS EN ISO 10993-10:2023
Replace
BS EN ISO 10993-10:2010

BS EN ISO 10993-10:2013 Referenced Document

  • ASTM F2148-07 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)*2023-12-24 Update
  • EN ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)*2020-11-30 Update
  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*2022-11-03 Update
  • ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*2019-11-26 Update
  • ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
  • ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
  • ISO 9394 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes

BS EN ISO 10993-10:2013 history

  • 2023 BS EN ISO 10993-10:2023 Biological evaluation of medical devices. Tests for skin sensitization
  • 2014 BS EN ISO 10993-10:2013 Biological evaluation of medical devices. Tests for irritation and skin sensitization
  • 2010 BS EN ISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
  • 0000 BS EN ISO 10993-10:2009
  • 2002 BS EN ISO 10993-10:2002 Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity
  • 0000 BS EN ISO 10993-10:1996
Biological evaluation of medical devices. Tests for irritation and skin sensitization



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