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Are there particular areas of laboratory medicine standardization that ISO/TC 212 is not involved in?

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The following areas are excluded from TC 212's scope of work:

  • Generic quality management standards addressed by ISO/TC 176
  • Quality management standards for medical devices addressed by ISO/TC 210
  • Reference material guidelines addressed by the ISO Committee on Reference Materials (REMCO)
  • Conformity assessment guidelines addressed by the ISO Committee on Conformity Assessment (CASCO)