NEN-EN-ISO 14155-1
Clinical investigation of medical devices for human subjects - Part 1: General requirements
inactive
| Organization: | NEN |
| Publication Date: | 1 March 2003 |
| Status: | inactive |
| Page Count: | 32 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
Defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to: - protect human subjects;- ensure the scientific conduct of the clinical investigation;- assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.
Document History
August 1, 2009
Clinical investigation of medical devices for human subjects - Part 1: General requirements
This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to protect human subjects, ensure...
NEN-EN-ISO 14155-1
March 1, 2003
Clinical investigation of medical devices for human subjects - Part 1: General requirements
Defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to: - protect human subjects;- ensure the scientific...
July 1, 2001
Clinical investigation of medical devices for human subjects - Part 1: General requirements
Defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to: - protect human subjects;- ensure the scientific...