DIN EN ISO 14155:2021
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020

Standard No.
DIN EN ISO 14155:2021
Release Date
2021
Published By
German Institute for Standardization
Status
 2020-12
Replace By
DIN EN ISO 14155:2020
DIN EN ISO 14155:2021-05
Latest
DIN EN ISO 14155:2020
DIN EN ISO 14155:2021-05
Scope
This standard addresses the technical aspects of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes by defining good clinical practices for their design, conduct, recording and reporting of clinica

DIN EN ISO 14155:2021 history

  • 2021 DIN EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
  • 2020 DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • 1970 DIN EN ISO 14155 E:2018-08 Good Clinical Practice for Clinical Investigation of Medical Devices in Anthropology (Draft)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020



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