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Clinical research on medical devices for human use

Clinical research on medical devices for human use, Total:7 items.

In the international standard classification, Clinical research on medical devices for human use involves: Laboratory medicine.


Danish Standards Foundation, Clinical research on medical devices for human use

  • DS/EN 540:1993 Clinical investigation of medical devices for human subjects

International Organization for Standardization (ISO), Clinical research on medical devices for human use

  • ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1

VN-TCVN, Clinical research on medical devices for human use

  • TCVN 7740-1-2007 Clinical investigation of medical devices for human subjects.Part 1: General requirements
  • TCVN 7740-2-2007 Clinical investigation of medical devices for human subjects.Part 2: Clinical investigation plans

European Committee for Standardization (CEN), Clinical research on medical devices for human use

  • EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

German Institute for Standardization, Clinical research on medical devices for human use

  • DIN EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11




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